IN.PACT™ AV IAV08004008PRecalls & reported problems

Summary

The FDA's MAUDE database contains 21 adverse event reports that list this exact device (DI 00763000232641), received between Oct 19, 2020 and Oct 21, 2025 — classified as 20 injuries, 1 malfunction.

The most frequently reported specific device problem is “Burst Container or Vessel” (1 report).

1 other recall cover devices cleared under the same FDA submission (P190008); they may or may not involve this specific model.

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.

Most reported problems

Recent adverse event reports

The 21 most recent of 21 reports, in the reporter's own words as published by the FDA.

• InjuryOct 21, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  DURING THE INDEX PROCEDURE AN IN.PACT AV ACCESS WAS USED TO TREAT THE LEFT ARM ANASTOMOSIS. APPROXIMATELY 2 YEARS 10 MONTHS POST PROCEDURE PATIENT SUFFERED STENOSIS OF JUXTA-ANASTOMOSIS. PROLONGED BLEEDING AND DECREASED FLOW DURING AND AFTER HD TREATMENTS. 7MM DIAMETER BALLOON USED TO PERFORM ANGIOPLASTY. POST-INTERVENTION GRAFTOGRAM DEMONSTRATED NO STENOSIS. PATIENT RECOVERED.

  Patient problems: Hemorrhage/Blood Loss/Bleeding; Reduced Blood Flow; Stenosis

  MAUDE report 23347845 ↗
• InjuryAug 19, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  DURING THE INDEX PROCEDURE AN IN.PACT AV ACCESS WAS USED TO TREAT THE LEFT ARM ANASTOMOSIS. APPROXIMATELY 18 MONTHS POST PROCEDURE PATIENT SUFFERED THROMBOSED DIALYSIS FISTULA. SUBJECT ADMITTED TO THE EMERGENCY DORM WITH CLOTTED FISTULA. UNDERWENT A SUCCESSFUL MECHANICAL THROMBOLYSIS AND ANGIOPLASTY. PATIENT RECOVERED.

  Patient problems: Thrombosis/Thrombus

  MAUDE report 22837015 ↗
• InjuryMar 31, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  DURING THE INDEX PROCEDURE TWO IN.PACT AV ACCESS BALLOONS WERE USED TO TREAT THE RIGHT ARM OUTFLOW VENOUS INTRA-GRAFT SEGMENT. A THIRD IN.PACT AV ACCESS BALLOON WAS LATER USED TO TREAT THE RIGHT ARM OUTFLOW VENOUS INTRA-GRAFT SEGMENT. APPROXIMATELY 23 MONTHS POST INDEX PROCEDURE PATIENT SUFFERED VESSEL RESTENOSIS OF OUTFLOW VEIN IN ARTERIOVENOUS GRAFT. CONTRAST INJECTION DEMONSTRATED SIMILAR MULTIFOCAL STENOSES SLUGGISH FLOW IN PERIPHERAL VEINS, THOUGH IMPROVED CONTRAST OPACIFICATION THROUGHOUT. STENT 6 X 100 75 CM MUSTANG USED TO PERFORM ANGIOPLASTY IN IMMEDIATE VENOUS OUTFLOW TRACT. ANGIOPLASTY WAS PERFORMED AT THE ARTERIAL END OF THE GRAFT NEAR THE BRACHIAL ANASTOMOSIS WITH A 6 X 40 MUSTANG. REPEAT ANGIOGRAPHY DEMONSTRATES OPACIFICATION THROUGHOUT THE INFLOW WITHOUT RESIDUAL STENOSIS. PATIENT RECOVERED.

  Patient problems: Stenosis

  MAUDE report 21730227 ↗
• InjuryMar 31, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  DURING THE INDEX PROCEDURE TWO IN.PACT AV ACCESS BALLOONS WERE USED TO TREAT THE RIGHT ARM VENOUS OUTFLOW. APPROXIMATELY 18 MONTHS POST PROCEDURE PATIENT SUFFERED VESSEL STENOSIS OF OUTFLOW VEIN IN ARTERIOVENOUS GRAFT. A STUDY OF VENOUS OUTFLOW WAS PERFORMED WHICH REVEALED MODERATE TO SEVERE MULTIFOCAL DISEASE THROUGHOUT THE AV GRAFT. THOUGH THERE WAS SOME IMPROVEMENT IN FLOW THROUGH THE AV GRAFT, THERE WERE PERSISTENT AREAS OF MODERATE STENOSIS THROUGHOUT THE AV GRAFT. A 7 MM X 4 CM BALLOON WAS USED TO PERFORM MULTI-STATION ANGIOPLASTY THROUGHOUT THE AV GRAFT VIA THE ANTEGRADE ACCESS. POST-TREATMENT FISTULOGRAM DEMONSTRATING IMPROVED FLOW AND LUMINAL GAIN. DIAGNOSTIC FISTULOGRAM REVEALED MULTIFOCAL AREAS OF STENOSIS IN OUTFLOW AXILLARY VEIN. SUCCESSFUL ANGIOPLASTY USING A 7 MM DORADO BALLOON. PATIENT RECOVERED.

  Patient problems: Stenosis

  MAUDE report 21730028 ↗
• InjuryFeb 4, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  DURING THE INDEX PROCEDURE AN INPACT AV ACCESS WAS USED TO TREAT THE RIGHT ARM VENOUS OUTFLOW . A SECOND INPACT AV ACCESS BALLOON WAS USED LATER TO TREAT THE RIGHT ARM. A THIRD INPACT AV ACCESS BALLOON WAS USED LATER. APPROXIMATELY 23 MONTHS POST INDEX PROCEDURE PATIENT SUFFERED VESSEL RESTENOSIS IN OUTFLOW VEIN OF ARTERIOVENOUS FISTULA.  ANGIOGRAPHY W/ CONTRAST DEMONSTRATED STENOSIS AND SLUGGISH FLOW IN TWO LESIONS LOCATED IN VENOUS OUTFLOW, FIRST LESION IDENTIFIED AS TARGET LESION #1, AND 2ND LESION # 2 ALSO IN VENOUS OUTFLOW. A 6 X 100 MUSTANG WAS USED TO PERFORM ANGIOPLASTY IN THE VENOUS OUTFLOW TRACT. REPEAT ANGIOGRAPHY ALONG OUTFLOW TRACT DEMONSTRATED PERSISTENT NARROWING. REPEAT BALLOON DILATION WAS PERFORMED WITH A 7 X 100 MUSTANG. FOLLOWING THIS, REPEAT FISTULOGRAM HAD FAST FLOW WITHOUT CENTRAL STENOSES OR FILLING DEFECTS. PATIENT RECOVERED.

  Patient problems: Stenosis

  MAUDE report 21307837 ↗
• InjuryFeb 4, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  DURING THE INDEX PROCEDURE TWO IN.PACT AV ACCESS BALLOONS WERE USED TO TREAT THE RIGHT ARM VENOUS OUTFLOW. ONE IN.PACT AV ACCESS WAS USED LATER TO TREAT RIGHT ARM. APPROXIMATELY 23 MONTHS POST PROCEDURE PATIENT SUFFERED THROMBOSIS IN ARTERIOVENOUS FISTULA. PHYSICIAN UNABLE TO COMPLETE PREVIOUS HEMODIALYSIS DUE TO CLOT. ANGIOGRAPHY PERFORMED DEMONSTRATED IN-STENT THROMBOSIS. THROMBECTOMY WAS PERFORMED USING A CLEANER DEVICE. FOGARTY BALLOON USED TO PULL ARTERIAL PLUG. ANGIOPLASTY USING 6 X 40 MUSTANG WAS PERFORMED NEAR BRACHIAL ANASTOMOSIS. REPEAT ANGIOPLASTY DEMONSTRATED OPACIFICATION THROUGHOUT INFLOW WITHOUT RESIDUAL STENOSIS. SUCCESSFUL DE-CLOT OF RIGHT UPPER EXTREMITY AV BRACHIO-AXILLARY GRAFT. TARGET LESION, VENOUS OUTFLOW, INVOLVED IN PROCEDURE.

  Patient problems: Thrombosis/Thrombus

  MAUDE report 21307734 ↗
• InjuryNov 7, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  DURING THE INDEX PROCEDURE TWO IN.PACT AV ACCESS WERE USED TO TREAT THE RIGHT ARM VENOUS OUTFLOW. ANOTHER IN.PACT AV ACCESS WAS USED TO TREAT THE RIGHT ARM. APPROXIMATELY 21 MONTHS POST INDEX PROCEDURE PATIENT SUFFERED VESSEL RESTENOSIS IN OUTFLOW VEIN OF ARTERIOVENOUS FISTULA. THE STUDY DEMONSTRATED SLOW FLOW AND MODERATE STENOSIS AT THE VENOUS OUTFLOW TARGET LESION. A 7MM MUSTANG BALLOON WAS ADVANCED ACROSS THE STENOSIS. POST DILATION ANGIOGRAPHY DEMONSTRATED MINIMAL RESIDUAL STENOSIS. A 7MM DRUG COATED LUTONIX BALLOON WAS ADVANCED ACROSS THE STENOSIS IN TARGET LESION. SUCCESSFUL ANGIOPLASTY OF VENOUS OUTFLOW TARGET LESION. PATIENT RECOVERED.

  Patient problems: Stenosis

  MAUDE report 20630580 ↗
• InjuryJul 25, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  DURING THE INDEX PROCEDURE TWO INPACT AV ACCESS WERE USED TO TREAT THE RIGHT ARM VENOUS OUTFLOW. A THIRD INPACT AV ACCESS WAS USED TO TREAT THE RIGHT ARM. APPROXIMATELY 18 MONTHS POST PROCEDURE PATIENT SUFFERED VESSEL RESTENOSIS OF OUTFLOW VEIN OF ARTERIOVENOUS FISTULA. A STUDY OF THE VENOUS OUTFLOW WAS PERFORMED WHICH REVEALED MODERATE TO SEVERE MULTIFOCAL STENOSIS. A 7MM X 4CM DORADO BALLOON WAS USED TO PERFORM ANGIOPLASTY THROUGHOUT VENOUS OUTFLOW. CONTRAST INJECTION DEMONSTRATED IMPROVED FLOW, THOUGH THERE WERE PERSISTENT AREAS OF MODERATE NARROWING. THE 7MM X 4CM DORADO BALLOON WAS USED TO PERFORM MULTI-STATION ANGIOPLASTY THROUGHOUT VENOUS OUTFLOW. POST-TREATMENT FISTULOGRAM DEMONSTRATED IMPROVED FLOW AND LUMINAL GAIN. SUCCESSFUL ANGIOPLASTY OF THE ENTIRETY OF VENOUS OUTFLOW. PATIENT RECOVERED.

  Patient problems: Stenosis

  MAUDE report 19829031 ↗
• InjuryJul 25, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  DURING THE INDEX PROCEDURE TWO IN. PACT AV ACCESS WERE USED TO TREAT THE RIGHT ARM VENOUS OUTFLOW. A THIRD IN. PACT AV ACCESS WAS USED TO TREAT THE RIGHT ARM. APPROXIMATELY 18 MONTHS POST PROCEDURE PATIENT SUFFERED THROMBOSIS IN ARTERIOVENOUS FISTULA. ANGIOGRAPHY WAS PERFORMED, DEMONSTRATING MULTIFOCAL STENOSIS OF AXILLARY OUTFLOW VEIN WITH THROMBOSIS OF RIGHT ARTERY TO AXILLARY VEIN AV GRAFT. THROMBECTOMY IN DIRECTION OF FLOW WAS PERFORMED USING ANGIOJET POSSIS DEVICE, FOR TOTAL OF 3 PASSES. FOGATARY BALLOON USED TO PULL ARTERIAL PLUS, ESTABLISHING ARTERIAL FLOW. 6MM X 6CM MUSTANG BALLOON USED TO PUSH THROMBUS CENTRALLY. SUCCESSFUL DECLOT OF THE RIGHT UPPER EXTREMITY AV GRAFT. PATIENT RECOVERED.

  Patient problems: Thrombosis/Thrombus

  MAUDE report 19828852 ↗
• InjuryJul 25, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  DURING THE INDEX PROCEDURE TWO INPACT AV ACCESS WERE USED TO TREAT THE RIGHT ARM VENOUS OUTFLOW. AN INPACT AV ACCESS WAS USED TO TREAT THE RIGHT ARM. APPROXIMATELY 18 MONTHS POST PROCEDURE PATIENT SUFFERED RESTENOSIS OF SUBCLAVIAN VEIN. MILD STENOSIS PRESENT WITHIN RIGHT CENTRAL SUBCLAVIAN VEIN. THE RIGHT CENTRAL SUBCLAVIAN VEIN WAS TREATED WITH A 10MM X 6CM MUSTANG BALLOON. POST ANGIOPLASTY VENOGRAM DEMONSTRATED LUMINAL PAIN AND IMPROVED FLOW WITHIN THE CENTRAL PORTION OF THE RIGHT SUBCLAVIAN VEIN. SUCCESSFUL ANGIOPLASTY OF THE CENTRAL SUBCLAVIAN VEIN TO 10MM. PATIENT RECOVERING.

  Patient problems: Stenosis

  MAUDE report 19828713 ↗
• InjuryJun 27, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  DURING THE INDEX PROCEDURE AN IN.PACT AV ACCESS WAS USED TO TREAT THE RIGHT ARM. ANOTHER IN.PACT AV ACCESS WAS USED TO TREAT THE RIGHT ARM SUBCLAVIAN VEIN. APPROXIMATELY 4 MONTHS POST PROCEDURE PATIENT SUFFERED VENOUS OUTFLOW-AXILLARY VEIN RESTENOSIS OF THE AV GRA FT. SUBJECT PRESENTED FOR ROUTINE FISTULOGRAM WITH COMPLAINTS OF CLOTTING DURING DIALYSIS AND POOR FLOW. VENOUS OUTFLOW-AXILLARY VEIN (INDEX LESION FOR STUDY ENROLMENT) TREATED WITH COVERED STENT GRAFT AND PLAIN BALLOON ANGIOPLASTY. NO IMMEDIATE COMPLICATIONS. DISCHARGED HOME SAME DAY. PATIENT RECOVERED.

  Patient problems: Stenosis

  MAUDE report 19624247 ↗
• InjuryJan 12, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  DURING THE INDEX PROCEDURE A IN.PACT AV ACCESS WAS USED TO TREAT THE LEFT ARM. APPROXIMATELY 21 MONTHS POST PROCEDURE PATIENT SUFFERED LEFT ARM AV - GRAFT VENOUS STENOSIS. PULSATILE THRILL OVER LEFT UPPER ARM AV GRAFT. C/O HIGH VENOUS PRESSURE DURING DIALYSIS. THE EVENT WAS TREATED WITH PERCUTANEOUS INTERVENTION. PATIENT RECOVERED.

  Patient problems: Stenosis

  MAUDE report 18501434 ↗
• InjuryOct 25, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  DURING THE INDEX PROCEDURE TWO IN.PACT AV ACCESS BALLOON CATHETERS WERE USED TO TREAT THE VENOUS OUTFLOW OF THE RIGHT ARM. APPROXIMATELY 7 MONTHS POST PROCEDURE THE PATIENT SUFFERED FROM VESSEL RESTENOSIS IN THE OUTFLOW VEIN OF THE ARTERIOVENOUS FISTULA. MILD STENOSIS IN THE PERIPHERAL AND CENTRAL GRAFT TO 3MM WAS NOTED. A 7 X 60MM NON MDT BALLOON WAS INTRODUCED AND AN ANGIOPLASTY WAS PERFORMED IN MULTIPLE STATIONS ACROSS THE ABOVE MENTIONED STENOSIS IN THE GRAFT WITH IMPROVEMENT IN LUMINAL DIAMETER TO 4MM OF BOTH STENOSES. THE PATIENT EXPERIENCED SYMPTOMS OF ELEVATED VENOUS PRESSURES AND PROLONGED BLEEDING. A 7 X 40MM IN.PACT AV ACCESS BALLOON WAS INTRODUCED AND 3 MINUTES OF ANGIOPLASTY TIME WAS APPLIED TO THE MORE PERIPHERAL OUTFLOW STENOSIS. A REPEAT ANTEGRADE FISTULOGRAPHY DEMONSTRATED IMPROVEMENT OF BOTH GRAFTS STENOSES TO 5MM LUMINAL DIAMETER COMPARED TO 3MM AT THE BEGINNING OF THE PROCEDURE. A 8 X 40MM NON MDT BALLOON WAS INTRODUCED AND CONVENTIONAL ANGIOPLASTY WAS PERFORMED IN MULTIPLE STATIONS OF THE MORE CENTRAL OUTFLOW GRAFT STENOSIS. IT WAS STATED THAT RESTENOSIS INVOLVED THE INDEX TARGET LESIONS. THE PATIENT IS RECOVERING.

  Patient problems: Insufficient Information; Stenosis

  MAUDE report 18003100 ↗
• InjurySep 20, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  DURING THE INDEX PROCEDURE ONE IN.PACT AV ACCESS BALLOON WAS USED TO TREAT THE IN CANNULATION ZONE OF THE LEFT ARM. DURING A SECOND PROCEDURE, THE ANASTOMOSIS OF THE LEFT ARM WAS TREATED USING A NON MDT BALLOON. DURING A THIRD PROCEDURE, THE CENTRAL VEIN AND THE ANASTOMOSIS OF THE LEFT ARM WERE TREATED WITH TWO IN.PACT AV ACCESS BALLOON AND TWO NON MDT BALLOONS. DURING A FOURTH PROCEDURE, THE ANASTOMOSIS OF THE LEFT ARM WAS TREATED USING TWO NON MDT BALLOONS. DURING A FIFTH PROCEDURE THE IN CANNULATION ZONE AND CENTRAL VEIN OF THE LEFT ARM WERE TREATED WITH ONE IN.PACT ADMIRAL BALLOON AND FOUR NON MDT BALLOONS. DURING A SIXTH PROCEDURE, THE IN CANNULATION ZONE OF THE LEFT ARM WAS TREATED WITH 6 NON MDT BALLOONS. DURING A SEVENTH PROCEDURE, THE CENTRAL VEIN OF THE LEFT ARM WAS TREATED WITH TWO NON MDT BALLOONS. APPROXIMATELY 17 MONTHS POST THE INDEX PROCEDURE, 14 MONTHS POST THE SECOND PROCEDURE, 11 MONTHS POST THE THIRD PROCEDURE, 10 MONTHS POST THE FOURTH PROCEDURE, 7 MONTH POST THE FIFTH PROCEDURE, 6 MONTHS POST THE SIXTH PROCEDURE AND 3 MONTHS POST THE SEVENTH PROCEDURE THE PATIENT SUFFERED FROM VENOUS OUTFLOW RESTENOSIS OF THE AVF. THE PATIENT PRESENTED FOR A ROUTINE FISTULOGRA

  Patient problems: Insufficient Information; Stenosis

  MAUDE report 17779625 ↗
• InjurySep 19, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  DURING THE INDEX PROCEDURE ONE IN.PACT AV ACCESS BALLOON WAS USED TO TREAT THE IN CANNULATION ZONE OF THE LEFT ARM. DURING A SECOND PROCEDURE, THE ANASTOMOSIS OF THE LEFT ARM WAS TREATED USING A NON MDT BALLOON. DURING A THIRD PROCEDURE, THE CENTRAL VEIN AND THE ANASTOMOSIS OF THE LEFT ARM WERE TREATED WITH TWO IN.PACT AV ACCESS BALLOON AND TWO NON MDT BALLOONS. DURING A FOURTH PROCEDURE, THE ANASTOMOSIS OF THE LEFT ARM WAS TREATED USING TWO NON MDT BALLOONS. DURING A FIFTH PROCEDURE THE IN CANNULATION ZONE AND CENTRAL VEIN OF THE LEFT ARM WERE TREATED WITH ONE IN.PACT ADMIRAL BALLOON AND FOUR NON MDT BALLOONS. DURING A SIXTH PROCEDURE, THE IN CANNULATION ZONE OF THE LEFT ARM WAS TREATED WITH 6 NON MDT BALLOONS. APPROXIMATELY 14 MONTHS POST THE INDEX PROCEDURE, 11 MONTHS POST THE SECOND PROCEDURE, 8 MONTHS POST THE THIRD PROCEDURE, 7 MONTHS POST THE FOURTH PROCEDURE, 4 MONTH POST THE FIFTH PROCEDURE AND 3 MONTHS POST THE SIXTH PROCEDURE, THE PATIENT SUFFERED FROM CENTRAL VEIN RESTENOSIS OF THE AV FISTULA. THE PATIENT PRESENTED FOR A ROUTINE FISTULOGRAM. THE IMAGING SHOWED 90% RESTENOSIS OF THE CENTRAL VEIN (NON INDEX LESION). THE EVENT WAS SUCCESSFULLY TREATED WITH A HIGH PRESSURE

  Patient problems: Insufficient Information; Stenosis

  MAUDE report 17772298 ↗
• InjuryMay 16, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  DURING THE INDEX PROCEDURE ONE IN.PACT AV ACCESS BALLOON CATHETER WAS USED TO TREAT THE ANASTOMOSIS OF THE LEFT ARM. APPROXIMATELY 6 MONTHS POST PROCEDURE THE PATIENT HAD A REVASCULARIZATION IN THE TARGET LIMB.

  Patient problems: Insufficient Information; Thrombosis/Thrombus

  MAUDE report 16937294 ↗
• InjuryMar 30, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  DURING THE INDEX PROCEDURE TWO IN PACT AV ACCESS BALLOON CATHETERS WERE USED TO TREAT THE VENOUS OUTFLOW OF THE RIGHT ARM. APPROXIMATELY 48 DAYS POST PROCEDURE THE PATIENT SUFFERED FROM VESSEL STENOSIS IN THE OUTFLOW VEIN OF THE ARTERIOVENOUS FISTULA. THE DIALYSIS CENTER REPORTED THAT THE PATIENT HAD A PROLONGED BLEEDING TIME FROM THE ACCESS SITE (NOT ANY LESION SITE) FOLLOWING DIALYSIS. A FISTULAGRAM WAS PERFORMED. ACCESS WAS AT THE ARTERIOVENOUS GRAFT EXTENDING FROM THE BRACHIAL ARTERY TO AXILLARY VEIN WHICH SHOWED ADEQUATE FLOW. MULTIFOCAL MILD TO MODERATE STENOSIS WAS NOTED IN THE LENGTH OF THE GRAFT. THE VENOUS ANASTOMOSIS STENT WAS PATENT. MILD STENOSIS WAS PRESENT IN THE RIGHT SUBCLAVIAN VEIN. A RETROGRADE ARTERIOGRAM SHOWED A WIDELY PATENT ANASTOMOSIS. THE EVENT WAS TREATED WITH AN ANGIOPLASTY. THE PATIENT RECOVERED.

  Patient problems: Hemorrhage/Blood Loss/Bleeding; Insufficient Information; Stenosis

  MAUDE report 16642053 ↗
• InjuryDec 12, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  DURING THE INDEX PROCEDURE ONE IN.PACT AV ACCESS BALLOON CATHETER WAS USED TO TREAT THE IN CANNULATION ZONE OF THE LEFT ARM. DURING A SECOND PROCEDURE, THE ANASTOMOSIS OF THE LEFT ARM WAS TREATED USING A NON MDT BALLOON. DURING A THIRD PROCEDURE, THE CENTRAL VEIN AND THE ANASTOMOSIS OF THE LEFT ARM WERE TREATED WITH ONE IN.PACT AV ACCESS BALLOON AND ONE NON MDT BALLOON EACH. DURING A FOURTH PROCEDURE, TWO NON MDT BALLOONS WERE USED TO TREAT THE ANASTOMOSIS OF THE LEFT ARM. APPROXIMATELY 11 MONTHS POST INDEX PROCEDURE, 8 MONTHS POST THE SECOND PROCEDURE, 4 MONTHS POST THE THIRD PROCEDURE AND 3 MONTHS POST THE FOURTH PROCEDURE, THE PATIENT SUFFERED FROM RESTENOSIS OF THE CANNULATION ZONE OF THE BRACHIO-BASILIC AVF. ANGIOGRAPHY SHOWED AREAS OF RESTENOSIS IN THE CANNULATION ZONE (INDEX TREATED LESION) AND RESTENOSIS OF THE CENTRAL VEIN. THE EVENT WAS TREATED WITH A PERCUTANEOUS INTERVENTION OF THE IN CANNULATION ZONE AND CENTRAL VEIN OF THE LEFT ARM USING ONE IN.PACT ADMIRAL BALLOON CATHETER, FOUR NON MDT BALLOONS AND A FOGARTY EMBOLECTOMY CATHETER. THE PATIENT RECOVERED. THE AE WAS ASSESSED AS POSSIBLY RELATED TO AN UNDERLYING CONDITION OR DISEASE.

  Patient problems: Stenosis

  MAUDE report 15958004 ↗
• InjuryDec 8, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  DURING THE INDEX PROCEDURE ONE IN.PACT AV ACCESS BALLOON CATHETER WAS USED TO TREAT THE VENOUS OUTFLOW OF THE LEFT ARM. APPROXIMATELY 09 MONTHS POST PROCEDURE PATIENT SUFFERED AV GRAFT RESTENOSIS OF THE LEFT ARM. IT WAS STATED THAT LOTS OF CLOTS WERE NOTED. THE EVENT WAS TREATED WITH A PERCUTANEOUS INTERVENTION OF THE VENOUS OUTFLOW (TARGET LESION). PATIENT RECOVERED. AE WAS ASSESSED AS POSSIBLY RELATED TO AN UNDERLYING CONDITION OR DISEASE.

  Patient problems: Insufficient Information; Stenosis

  MAUDE report 15944839 ↗
• InjuryJun 2, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  DURING THE INDEX PROCEDURE ONE IN.PACT AV ACCESS BALLOON CATHETER WAS USED TO TREAT THE VENOUS OUTFLOW OF THE LEFT ARM. APPROXIMATELY 3 MONTHS POST PROCEDURE THE PATIENT SUFFERED FROM LEFT ARM AV GRAFT VENOUS AND INTRAGRAFT STENOSIS. THE PATIENT'S LEFT UPPER EXTREMITY WAS REPORTED TO BE PAINFUL AND SWOLLEN. THE EVENT WAS TREATED WITH A PERCUTANEOUS INTERVENTION. THE PATIENT RECOVERED. THE AE WAS ASSESSED AS POSSIBLY RELATED TO AN UNDERLYING CONDITION OR DISEASE.

  Patient problems: Insufficient Information; Pain; Stenosis; Swelling/ Edema

  MAUDE report 14571786 ↗
• MalfunctionOct 19, 2020Burst Container or Vessel; Burst Container or Vessel

  PHYSICIAN WAS ATTEMPTING TO USE AN INPACT AV ACCESS PACLITAXEL ELUTING BALLOON ALONG WITH NON-MEDTRONIC 6/7FR SHEATH, AND 0.018" GUIDE WIRE DURING PROCEDURE TO TREAT A MODERATELY CALCIFIED FIBROUS LESION IN THE LEFT ARTERIOVENOUS WITH 70% STENOSIS. THE VESSEL WAS MODERATELY TORTUOUS. A NON-MEDTRONIC INFLATION DEVICE WAS USED TO INFLATE THE BALLOON. THERE WAS NO DAMAGE NOTED TO PACKAGING. THERE WAS NO ISSUE NOTED WHEN REMOVING THE DEVICE FROM THE HOOP/TRAY. THE DEVICE WAS PREPPED PER IFU WITH NO ISSUES IDENTIFIED. BALLOON BURST, LEAK, OR CATHETER LEAK OCCURRED. DURING BALLOON INFLATION, A LONGITUDINAL BALLOON RUPTURE OCCURRED AT 2-5ATM. ON THE FIRST INFLATION WAS APPLIED TO THE DEVICE PRIOR TO THE ISSUE OCCURRING. THE DEVICE PASSED THROUGH A PREVIOUSLY DEPLOYED STENT. IT WAS REPORTED THAT AS PHYSICIAN BEGAN TO INFLATE, THE BALLOON RUPTURED. A NEW DCB WAS USED TO COMPLETE THE PROCEDURE. THERE WAS NO PATIENT INJURY REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions; No Consequences Or Impact To Patient

  MAUDE report 10696204 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under P190008. One submission often covers many models, so check the product and lot details in each record.

• Z-1043-2022 · Mar 23, 2022 · Open, Classified
  Medtronic IN.PACT AV, Paclitaxel-coated PTA Balloon Catheter, REF: IAV06008008P, Sterile EO, Rx Only