Amplatz Super Stiff™ M001465260Recalls & reported problems

Summary

The FDA's MAUDE database contains 32 adverse event reports that list this exact device (DI 08714729295747), received between Aug 23, 2018 and Sep 16, 2026 — classified as 32 malfunctions.

The most frequently reported specific device problem is “Material Integrity Problem” (14 reports).

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 25 most recent of 32 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 16, 2026Difficult to Remove

  It was reported that removal difficulty occurred.The non-stenosed target lesion was located in the severely tortuous and non-calcified thoracic descending aorta. An Amplatz Super Stiff guidewire was selected for use. During the procedure, a non-BSC stent graft was inserted into the guidewire lumen, however, it was very difficult to remove after the graft had been placed. The catheter and guide wire were removed separately. There were no patient complications as a result of this event.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50788913 ↗
• MalfunctionDec 15, 2025Difficult to Remove; Difficult to Remove

  IT WAS REPORTED THAT REMOVAL DIFFICULTY OCCURRED. AN AMPLATZ SUPER STIFF GUIDEWIRE WAS SELECTED FOR USE DURING AN INTERVENTIONAL THERAPY PROCEDURE FOR HEART DISEASE. THE TARGET LESION WAS IN A 50% STENOSED, NON-CALCIFIED, CHALLENGING BUT MILDLY TORTUOUS AORTA. DURING THE PROCEDURE, THE GUIDEWIRE COULD NOT BE WITHDRAWN. THE GUIDEWIRE WAS REMOVED ALONG WITH THE CATHETER, AND THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. THERE WERE NO PATIENT COMPLICATIONS AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23809427 ↗
• MalfunctionNov 6, 2025Unraveled Material; Deformation Due to Compressive Stress; Detachment of Device or Device Component; Difficult to Open or Remove Packaging Material; Material Deformation; Adverse Event Without Identified Device or Use Problem; Unraveled Material; Deformation Due to Compressive Stress; Detachment of Device or Device Component; Difficult to Open or Remove Packaging Material; Material Deformation; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT GUIDEWIRE FRACTURE OCCURRED. AN AMPLATZ SUPER STIFF WAS SELECTED FOR USE. UPON REMOVING FROM THE PACKAGING TUBE, IT WAS NOTED THAT IT WAS STUCK INSIDE THE HYPOTUBE AND BECAME ELONGATED. A BREAK/FRACTURE WAS NOTED AT THE TIP OF THE GUIDEWIRE, AND A KINK WAS NOTED AT THE DISTAL PART OF THE GUIDEWIRE. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. THERE WERE NO PATIENT COMPLICATIONS AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23490646 ↗
• MalfunctionAug 14, 2025Unraveled Material; Difficult to Advance; Adverse Event Without Identified Device or Use Problem; Unraveled Material; Difficult to Advance; Adverse Event Without Identified Device or Use Problem

  REPORTABLE BASED ON DEVICE ANALYSIS COMPLETED ON 18JUL2025. IT WAS REPORTED THAT THE GUIDEWIRE WAS UNABLE TO ADVANCE AND BECAME UNRAVELED. AN AMPLATZ SUPER STIFF GUIDEWIRE WAS SELECTED FOR USE. DURING THE PROCEDURE, IT WAS NOTED THAT THE GUIDEWIRE COULD NOT MOVE ADVANCE IN THE LESION. THE DEVICE WAS REMOVED, AND IT WAS NOTED THAT THE GUIDEWIRE HAS BECOME LOOSE. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. THERE WERE NO PATIENT COMPLICATIONS AS A RESULT OF THIS EVENT. HOWEVER, DEVICE ANALYSIS REVEALED THAT THE CORE WIRE WAS DETACHED. THE DEVICE WAS RETURNED FOR EVALUATION. VISUAL INSPECTION REVEALED THAT THE DISTAL TIP WAS STRETCHED, MOREOVER THE CORE WIRE WAS DETACHED, AND THE SPRING TIP WAS UNRAVELED. NO OTHER ISSUES WERE IDENTIFIED DURING THE PRODUCT ANALYSIS. THERE IS A PICTURE ATTACHED IN THE PARENT RECORD, IT WAS POSSIBLE TO OBSERVED THAT THE DEVICE WAS STRETCHED. NO OTHER ISSUES WERE IDENTIFIED WITH THE DEVICE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22806874 ↗
• MalfunctionJul 8, 2025Entrapment of Device; Material Integrity Problem; Entrapment of Device; Material Integrity Problem

  IT WAS REPORTED THAT A COATING ISSUE OCCURRED. AN AMPLATZ SUPER STIFF WAS SELECTED FOR USE. IT WAS OBSERVED THAT THE GUIDEWIRE COATING BECAME LOOSE. AS IT WAS INSERTED INTO A CATHETER, THE GUIDEWIRE BECAME ENTRAPPED. IT OCCURRED ON SEVEN AMPLATZ GUIDEWIRES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22437239 ↗
• MalfunctionJun 16, 2025Material Integrity Problem; Material Integrity Problem

  IT WAS REPORTED THAT COATING ISSUE OCCURRED. THE NON-STENOSED TARGET LESION WAS LOCATED IN A NON-TORTUOUS AND NO-CALCIFIED VESSEL OF HEART. A 035/260 AMPLATZ SUPER STIFF GUIDE WIRE WAS SELECTED FOR USE. DURING THE PROCEDURE, IT WAS NOTED THAT THE COATING HAD PEELED OFF. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. THERE WERE NO PATIENT COMPLICATIONS AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22212042 ↗
• MalfunctionApr 18, 2025Difficult to Advance; Device Contamination with Chemical or Other Material; Difficult to Advance; Device Contamination with Chemical or Other Material

  IT WAS REPORTED THAT FOREIGN MATERIAL WAS OBSERVED. THE TARGET LESION WAS LOCATED IN A NOT VERY TORTUOUS AND NON-CALCIFIED VESSEL. A 035/260 AMPLATZ SUPER STIFF GUIDEWIRE WAS SELECTED FOR USE. DURING THE PROCEDURE, IT WAS NOTED THAT THE GUIDEWIRE WOULD NOT LOAD INTO CATHETER DUE TO SOME FOREIGN MATERIAL ON IT. THE PROCEDURE WAS COMPLETED WITH A DIFFERENT AMPLATZ GUIDEWIRE. THERE WERE NO PATIENT COMPLICATIONS AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21865727 ↗
• MalfunctionApr 2, 2025Material Integrity Problem; Adverse Event Without Identified Device or Use Problem; Material Integrity Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT TIP DETACHMENT OCCURRED. THE PATIENT WAS SUPINE AND UNDERWENT ANTEROGRADE PUNCTURE OF THE RIGHT FEMORAL ARTERY. MESENTERIC ARTERY STENOSIS WAS DETECTED BY ANGIOGRAPHY AND MESENTERIC ARTERY STENT IMPLANTATION WAS PERFORMED. AN AMPLATZ SUPER STIFF WAS SELECTED FOR USE. DURING PREPARATION, WHEN OPENED, IT WAS NOTED THAT THE TIP OF THE GUIDEWIRE WAS CRACKED. THE PROCEDURE WAS COMPLETED ANOTHER OF THE SAME DEVICE. NO COMPLICATIONS WERE REPORTED, AND THE PATIENT WAS STABLE POST PROCEDURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21753573 ↗
• MalfunctionMar 27, 2025Material Protrusion/Extrusion; Adverse Event Without Identified Device or Use Problem; Material Protrusion/Extrusion; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE WIRE PROTRUDED ABOUT 3 CM FROM THE TIP. THE 50% STENOSED TARGET LESION WAS LOCATED IN THE MILDLY TORTUOUS VESSEL. A 035/260 AMPLATZ SUPER STIFF GUIDEWIRE WAS SELECTED FOR ENDOVASCULAR THROMBECTOMY (EVT) PROCEDURE. DURING THE PROCEDURE, IT WAS NOTED THAT THE WIRE PROTRUDED ABOUT 3 CM FROM THE TIP. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. NO PATIENT INJURY WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21710995 ↗
• MalfunctionMar 25, 2025Difficult to Advance; Material Integrity Problem; Difficult to Advance; Material Integrity Problem

  IT WAS REPORTED THAT THE COATING HAD PEELED. AN AMPLATZ SUPER STIFF GUIDEWIRE WAS SELECTED FOR USE IN A COLONIC STENT IMPLANTATION. DURING IMPLANTATION OF A COLONIC STENT, THE STENT WOULD NOT SLIDE OVER THE AMPLATZ SUPER STIFF GUIDEWIRE. A NEW AMPLATZ SUPER STIFF WAS SELECTED FOR USE, BUT THE SAME ISSUE OCCURRED. UPON CLOSER INSPECTION OF THE TWO AMPLATZ SUPER STIFF GUIDEWIRES, IT APPEARED THAT THE COATING HAD PEELED OFF. A THIRD AMPLATZ SUPER STIFF GUIDEWIRE WAS USED, WHICH HAD A DIFFERENT BATCH NUMBER, AND THE PROCEDURE WAS SUCCESSFULLY COMPLETED. THERE WERE NO PATIENT COMPLICATIONS AS A RESULT OF THE EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21692098 ↗
• MalfunctionMar 25, 2025Difficult to Advance; Material Integrity Problem; Difficult to Advance; Material Integrity Problem

  IT WAS REPORTED THAT THE COATING HAD PEELED. AN AMPLATZ SUPER STIFF GUIDEWIRE WAS SELECTED FOR USE IN A COLONIC STENT IMPLANTATION. DURING IMPLANTATION OF A COLONIC STENT, THE STENT WOULD NOT SLIDE OVER THE AMPLATZ SUPER STIFF GUIDEWIRE. A NEW AMPLATZ SUPER STIFF WAS SELECTED FOR USE, BUT THE SAME ISSUE OCCURRED. UPON CLOSER INSPECTION OF THE TWO AMPLATZ SUPER STIFF GUIDEWIRES, IT APPEARED THAT THE COATING HAD PEELED OFF. A THIRD AMPLATZ SUPER STIFF GUIDEWIRE WAS USED, WHICH HAD A DIFFERENT BATCH NUMBER, AND THE PROCEDURE WAS SUCCESSFULLY COMPLETED. THERE WERE NO PATIENT COMPLICATIONS AS A RESULT OF THE EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21692097 ↗
• MalfunctionJan 9, 2025Detachment of Device or Device Component; Adverse Event Without Identified Device or Use Problem; Detachment of Device or Device Component; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT GUIDEWIRE DETACHMENT OCCURRED. AN AMPLATZ SUPER STIFF GUIDEWIRE WAS SELECTED FOR USE. DURING PREPARATION, IT WAS NOTED THE TIP WAS FRAYED AND SEPARATED. THE PROCEDURE WAS COMPLETED WITH A DIFFERENT DEVICE. NO COMPLICATIONS WERE REPORTED, AND THE PATIENT WAS STABLE POST PROCEDURE. IT WAS FURTHER REPORTED THAT THERE WAS VISUAL SEPARATION NOTED WITH THE DEVICE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21114413 ↗
• MalfunctionMay 22, 2024Entrapment of Device; Stretched; Entrapment of Device; Stretched

  IT WAS REPORTED THAT GUIDEWIRE TIP WAS STRETCHED AND STUCK OCCURRED. AN AMPLATZ SUPER STIFF GUIDEWIRE WAS SELECTED FOR USE ALONG WITH A NON-BOSTON SCIENTIFIC THROMBECTOMY SYSTEM. DURING THE SECOND THROMBECTOMY PROCEDURE, IT WAS NOTED THAT THE TIP OF THE WIRE WAS STRETCHED WHEN TRYING TO PASS THE CATHETER FOR THE SECOND TIME. THE WIRE BECAME STUCK WITH THE CATHETER AND WAS NOT MOVING. BOTH THE WIRE AND THROMBECTOMY DEVICE WERE REMOVED TOGETHER AS IT COULD NOT BE DETACHED FROM ONE ANOTHER. THE PROCEDURE WAS COMPLETED. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19370851 ↗
• MalfunctionMay 16, 2024Stretched; Adverse Event Without Identified Device or Use Problem; Stretched; Adverse Event Without Identified Device or Use Problem

  REPORTABLE BASED ON DEVICE ANALYSIS COMPLETED ON (B)(6) 2024. IT WAS REPORTED THAT GUIDEWIRE STRETCHED OCCURRED. AN AMPLATZ SUPER STIFF GUIDEWIRE WAS SELECTED FOR USE. UPON UNPACKING, IT WAS FOUND THAT THE GUIDEWIRE WAS STRETCHED AND COULD NOT BE USED NORMALLY. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. THERE WERE NO PATIENT COMPLICATIONS REPORTED. HOWEVER, RETURNED DEVICE ANALYSIS REVEALED CORE WIRE SEPARATION FROM BALD SOLDER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19336866 ↗
• MalfunctionMay 16, 2024Stretched; Adverse Event Without Identified Device or Use Problem; Stretched; Adverse Event Without Identified Device or Use Problem

  REPORTABLE BASED ON DEVICE ANALYSIS COMPLETED ON (B)(6) 2024. IT WAS REPORTED THAT GUIDEWIRE STRETCHED OCCURRED. THE TARGET LESION WAS LOCATED IN THE LIVER. AN AMPLATZ SUPER STIFF WAS SELECTED FOR PERCUTANEOUS ATRIAL SEPTAL DEFECT CLOSURE PROCEDURE. HOWEVER, THE WIRE WAS FOUND STRETCHED AND COULD NOT BE USED NORMALLY. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. THERE WERE NO PATIENT COMPLICATIONS REPORTED. HOWEVER, RETURNED DEVICE ANALYSIS REVEALED CORE WIRE SEPARATION FROM BALD SOLDER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19336603 ↗
• MalfunctionFeb 5, 2024Unraveled Material; Failure to Advance; Unraveled Material; Failure to Advance

  REPORTABLE BASED ON DEVICE ANALYSIS COMPLETED ON 11JAN2024. THE STENOSED TARGET LESION WAS LOCATED IN THE LEFT ILIAC ARTERY WHERE THE PATIENT UNDERWENT A BALLOON DILATION AND STENT IMPLANTATION. THE PATIENT WAS SUPINE DURING THE PROCEDURE AND THEIR RIGHT FEMORAL WAS PUNCTURED WHERE A 6-FRENCH SHEATH WAS USED FOR THE PUNCTURE FOLLOWED BY A NON-BOSTON SCIENTIFIC 7-FRENCH SHEATH. AN XCH/035/260 (BX/5) AMPLATZ GUIDEWIRE WAS ADVANCED, AND IT ENTERED THE ARTERY. THERE WAS DIFFICULTY IN MOVING FORWARD OR BACK AND IT FAILED TO CROSS THE LESION AFTER SEVERAL ATTEMPTS. THE DEVICE WAS REMOVED FROM THE PATIENT AND DISCOVERED TO BE BADLY STRETCHED. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME MODEL WHERE THE PATIENT STATUS WAS IN A STABLE CONDITION. NO COMPLICATIONS WERE REPORTED. HOWEVER, WHEN THE DEVICE WAS RETURNED FOR AN ANALYSIS, IT REVEALED THAT THE CORE WIRE WAS FOUND DETACHED/SEPARATED FROM THE DISTAL TIP OF THE BALD WELD. IN ADDITION, THE GUIDEWIRE WAS BENT IN THE DISTAL SECTION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18647234 ↗
• MalfunctionJan 18, 2024Material Integrity Problem; Material Integrity Problem

  IT WAS REPORTED THAT COATING ISSUE OCCURRED. A 035/260 (BX/5) AMPLATZ SUPER STIFF GUIDEWIRE WAS SELECTED FOR USE. DURING THE COURSE OF THE PROCEDURE, IT WAS NOTED THAT THE OUTER COATING CAME OFF OF THE MANDRILL. THE PROCEDURE WAS COMPLETED WITH A NEW WIRE. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18536052 ↗
• MalfunctionNov 15, 2023Material Deformation; Material Integrity Problem; Material Deformation; Material Integrity Problem

  REPORTABLE BASED ON DEVICE ANALYSIS COMPLETED ON 30OCT2023. IT WAS REPORTED THAT DEVICE WAS KINKED AND DAMAGED. THE TARGET LESION WAS LOCATED IN AORTA. AFTER UNPACKING A 035/260 AMPLATZ SUPER STIFF WIRE, IT WAS NOTED THAT THE TIP OF THE DEVICE WAS KINKED AND DAMAGED. THE DEVICE COULD NOT BE USED. THE PROCEDURE WAS COMPLETED WITH ANOTHER SAME DEVICE. THERE WERE NO PATIENT COMPLICATIONS REPORTED, AND THE PATIENT WAS STABLE POST-PROCEDURE. HOWEVER, RETURNED DEVICE ANALYSIS REVEALED THAT GUIDEWIRE WAS DETACHED/SEPARATED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18143774 ↗
• MalfunctionMar 20, 2023Device Contamination with Chemical or Other Material; Device Contamination with Chemical or Other Material

  IT WAS REPORTED THAT A FOREIGN MATERIAL WAS FOUND ON THE DEVICE. A 035/260 AMPLATZ SUPER STIFF GUIDEWIRE WAS SELECTED FOR USE. HOWEVER, DURING PREPARATION, A FOREIGN MATTER WAS FOUND IN INDIVIDUAL PRODUCT BAG. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. THERE WERE NO PATIENT COMPLICATIONS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16577164 ↗
• MalfunctionFeb 27, 2023Difficult to Advance; Material Integrity Problem; Difficult to Advance; Material Integrity Problem

  IT WAS REPORTED THAT GUIDEWIRE COATING ISSUE OCCURRED. THE OCCLUDED TARGET LESION WAS LOCATED IN A VESSEL IN THE LEG. A 035/260 AMPLATZ SUPER STIFF GUIDEWIRE WAS SELECTED FOR USE. HOWEVER, IT WAS NOTICED THAT THE GUIDEWIRE SEEMED TO BE IRREGULAR AND WOULD NOT ALLOW BALLOON TO TRACK OVER IT. WHEN LOOKED AT CLOSELY, IT SEEMED TO HAVE TEXTURE TO IT AND ACTUAL FRAYING TO THE WIRE. THE PROCEDURE WAS COMPLETED WITH ANOTHER DEVICE. THERE WERE NO PATIENT COMPLICATIONS NOR INJURIES REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16444338 ↗
• MalfunctionDec 8, 2022Device Contaminated During Manufacture or Shipping; Device Contaminated During Manufacture or Shipping

  IT WAS REPORTED THAT DEVICE CONTAMINATION OCCURRED. A 035/260 (BX/1) AMPLATZ SUPER STIFF GUIDEWIRE WAS SELECTED FOR USE; HOWEVER, A HAIRLIKE SUBSTANCE WAS NOTED WITHIN THE STERILIZATION BAG BEFORE THE DEVICE WAS OPENED. NO PATIENT INJURIES WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15941111 ↗
• MalfunctionJul 20, 2022Entrapment of Device; Difficult to Advance; Material Integrity Problem; Entrapment of Device; Difficult to Advance; Material Integrity Problem

  IT WAS REPORTED THAT COATING ISSUE AND GUIDEWIRE ENTRAPMENT OCCURRED. THE STENOSED TARGET LESION WAS LOCATED IN THE SUPERFICIAL FEMORAL ARTERY. A 035/260 AMPLATZ SUPER STIFF GUIDEWIRE WAS ADVANCED ACROSS THE LESION. A .035 NON-BOSTON SCIENTIFIC (BSC) STENT WAS ATTEMPTED TO TRACK OVER THE WIRE; HOWEVER, THE STENT WOULD ONLY TRACK A SHORT SEGMENT OF THE WIRE AND GOT STUCK. MULTIPLE ATTEMPTS WERE MADE AT FLUSHING THE DEVICE AND THEN PUSHING BACK OVER THE WIRE WITHOUT SUCCESS. BOTH THE WIRE AND THE STENT WERE REMOVED FROM THE PATIENT AS ONE UNIT AND THE PHYSICIAN NOTICED AN EXTRA THICK IN A CERTAIN SECTION OF THE WIRE AS IF THE COATING WAS BUNCHED UP ON THE WIRE. THE PROCEDURE WAS COMPLETED WITH A NON-BSC DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15065973 ↗
• MalfunctionFeb 8, 2022Entrapment of Device; Material Integrity Problem; Entrapment of Device; Material Integrity Problem

  IT WAS REPORTED THAT GUIDEWIRE ENTRAPMENT AND COATING ISSUE OCCURRED. THE TARGET LESION WAS LOCATED IN THE SEVERELY TORTUOUS AND MILDLY CALCIFIED ABDOMINAL AORTA. A S/S XCH/035/260 (BX/1) AMPLATZ - PI GUIDEWIRE WAS ADVANCED TO DELIVER A STENT GRAFT. HOWEVER, IT WAS OBSERVED THAT THE SHAFT WAS NOT SLIPPERY AND UPON REMOVAL AFTER THE STENT GRAFT WAS PLACED, THE GUIDEWIRE WAS STUCK. BOTH THE GUIDE WIRE AND STENT GRAFT WERE REMOVED TOGETHER. FURTHERMORE, THE SHAFT PART OF THE GUIDEWIRE WAS NOT COATED. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13490452 ↗
• MalfunctionFeb 7, 2022Material Deformation; Material Deformation

  REPORTABLE BASED ON DEVICE ANALYSIS COMPLETED ON 12-JAN-2022. IT WAS REPORTED THAT GUIDEWIRE DAMAGE WAS ENCOUNTERED. THE PATIENT PRESENTED WITH MAY-THURNER SYNDROME (MTS). A 035/260 (BX/1) AMPLATZ SUPER STIFF GUIDEWIRE WAS SELECTED FOR USE. HOWEVER, DURING UNPACKING, IT WAS NOTED THAT THE GUIDEWIRE WAS UNCOILED AND WAS NEVER INSERTED INTO THE PATIENT'S BODY. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF SAME DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED. HOWEVER, RETURNED DEVICE ANALYSIS REVEALED DISTAL END DETACHMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13474848 ↗
• MalfunctionJan 4, 2022Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT THE GUIDEWIRE DISTAL TIP DETACHED. A .035 X 260 CM AMPLATZ GUIDEWIRE WAS SELECTED FOR USE IN A FILTER RETRIEVAL. DURING PREPARATION, WHILE THE DEVICE WAS EXTERNAL TO THE PATIENT, THE DISTAL TIP WAS OBSERVED TO BE DETACHED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13155271 ↗