Indigo System CAT5-ARecalls & reported problems

Summary

The FDA's MAUDE database contains 26 adverse event reports that list this exact device (DI 00814548016092), received between Apr 6, 2016 and Oct 8, 2021 — classified as 26 malfunctions.

The most frequently reported specific device problem is “Break” (7 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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 25 most recent of 26 reports, in the reporter's own words as published by the FDA.

• MalfunctionOct 8, 2021Break; Break

  THE PATIENT WAS UNDERGOING A THROMBECTOMY PROCEDURE IN THE LEFT POSTERIOR TIBIAL ARTERY USING AN INDIGO SYSTEM ASPIRATION CATHETER 5 (CAT5), A NON-PENUMBRA SHEATH, AND A GUIDEWIRE. DURING THE PROCEDURE, THE PHYSICIAN COMPLETED ONE PASS USING THE CAT5. WHILE RETRACTING THE CAT5 OUT OF THE PATIENT¿S BODY TO CHECK IF THE CAT5 WAS CLOGGED, THE PHYSICIAN BROKE THE CAT5 APPROXIMATELY 12 INCHES FROM THE DISTAL TIP. THEREFORE, THE CAT5 WAS REMOVED, AND THE BROKEN DISTAL END OF THE CAT5 WAS REMOVED ALONG WITH THE GUIDEWIRE. THE PROCEDURE WAS COMPLETED USING AN ADDITIONAL CAT5 AND THE SAME SHEATH. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12599522 ↗
• MalfunctionApr 6, 2021Material Deformation; Material Twisted/Bent; Material Deformation; Material Twisted/Bent

  THE PATIENT WAS UNDERGOING A THROMBECTOMY PROCEDURE TO TREAT AN ARTERIOVENOUS (AV) FISTULA IN THE RIGHT ARM USING AN INDIGO SYSTEM CAT5 ASPIRATION CATHETER (CAT5), AN INDIGO SYSTEM SEPARATOR 5 (SEP5), A 5F SHEATH, AND A GUIDEWIRE. DURING THE PROCEDURE, THE PHYSICIAN ACCESSED THE FISTULA WITH THE SHEATH AND ADVANCED THE CAT5 OVER THE GUIDEWIRE AND PAST THE THROMBUS. SUBSEQUENTLY, THE PHYSICIAN PULLED THE CAT5 BACK INTO THE CLOT AND DECIDED TO USE THE SEP5. HOWEVER, THE SEP5 WOULD NOT ADVANCE TO THE END OF THE CAT5. THEREFORE, THE WHOLE SYSTEM WAS REMOVED, AND IT WAS FOUND THAT THE DISTAL END OF THE CAT5 WAS BENT AND KINKED. THE PROCEDURE WAS COMPLETED USING AN INDIGO SYSTEM CATD ASPIRATION CATHETER (CATD). THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11623632 ↗
• MalfunctionJun 24, 2019Material Deformation; Material Deformation

  THE PATIENT WAS UNDERGOING A THROMBECTOMY PROCEDURE IN THE FEMORAL ARTERY USING INDIGO SYSTEM CAT5 ASPIRATION CATHETER (CAT5). DURING THE PROCEDURE, WHILE ATTEMPTING TO ADVANCE THE CAT5 THROUGH A NON-PENUMBRA SHEATH, THE DISTAL END OF THE CAT5 BECAME KINKED AND, THEREFORE, IT WAS REMOVED. THE PROCEDURE WAS COMPLETED USING A NEW CAT5 AND THE SAME SHEATH. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8726837 ↗
• MalfunctionJun 20, 2019Break; Device Damaged Prior to Use; Break; Device Damaged Prior to Use

  DURING PREPARATION FOR A THROMBECTOMY PROCEDURE, THE PHYSICIAN FOUND THAT AN INDIGO SYSTEM CAT5 ASPIRATION CATHETER (CAT5) WAS BROKEN INTO TWO PIECES UPON REMOVAL FROM THE PACKAGING. THE DAMAGE TO THE CAT5 WAS FOUND PRIOR TO USE. THEREFORE, THE CAT5 WAS NOT USED IN THE PROCEDURE. THE PROCEDURE WAS COMPLETED USING A NEW CAT5.

  Patient problems: No Patient Involvement

  MAUDE report 8716722 ↗
• MalfunctionJun 5, 2019Device Damaged Prior to Use; Device Handling Problem; Device Damaged Prior to Use; Device Handling Problem

  DURING PREPARATION FOR A THROMBECTOMY PROCEDURE, AN INDIGO SYSTEM CAT5 ASPIRATION CATHETER (CAT5) WAS ACCIDENTALLY DROPPED ON THE FLOOR AFTER REMOVAL FROM THE PACKAGING. THE CAT5 WAS CONTAMINATED PRIOR TO USE AND, THEREFORE, IT WAS NOT USED IN THE PROCEDURE. THE PROCEDURE WAS COMPLETED USING A NEW CAT5.

  Patient problems: No Patient Involvement

  MAUDE report 8670919 ↗
• MalfunctionMay 1, 2019Material Deformation; Physical Resistance/Sticking; Material Deformation; Physical Resistance/Sticking

  THE PATIENT WAS UNDERGOING A THROMBECTOMY PROCEDURE IN THE POPLITEAL ARTERY USING AN INDIGO SYSTEM CAT5 ASPIRATION CATHETER (CAT5). DURING THE PROCEDURE, THE PHYSICIAN FELT RESISTANCE WHILE ADVANCING THE CAT5 INTO THE NON-PENUMBRA SHEATH AFTER MAKING TWO PASSES. CONSEQUENTLY, THE CAT5 BECAME KINKED. THE PROCEDURE WAS THEN COMPLETED USING AN INDIGO SYSTEM CAT3 ASPIRATION CATHETER (CAT3) AND THE SAME SHEATH. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8571194 ↗
• MalfunctionDec 19, 2018Material Deformation; Material Deformation

  THE PATIENT WAS UNDERGOING A THROMBECTOMY PROCEDURE IN THE POPLITEAL AND TIBIOPERONEAL TRUNK USING AN INDIGO SYSTEM CAT5 ASPIRATION CATHETER (CAT5). DURING THE PROCEDURE, THE PHYSICIAN WAS UNABLE TO ASPIRATE WITH THE CAT5 AND UPON FURTHER INSPECTION A KINK WAS FOUND IN THE MID SHAFT OF THE CAT5; THEREFORE, IT WAS REMOVED. THE PROCEDURE WAS COMPLETED USING AN INDIGO SYSTEM ASPIRATION CATHETER 6 (CAT6). THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8179557 ↗
• MalfunctionNov 12, 2018Material Puncture/Hole; Material Puncture/Hole

  THE PATIENT WAS UNDERGOING A THROMBECTOMY PROCEDURE IN THE POSTERIOR TIBIAL ARTERY USING AN INDIGO SYSTEM CAT5 ASPIRATION CATHETER (CAT5). DURING THE PROCEDURE, THE PHYSICIAN ADVANCED A NON-PENUMBRA GUIDEWIRE THROUGH THE CAT5 AND PUNCTURED THE DISTAL END OF THE CAT5; THEREFORE, THE CAT5 WAS REMOVED. THE PROCEDURE WAS COMPLETED USING A NEW CAT5. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8059547 ↗
• MalfunctionJul 2, 2018Kinked; Aspiration Issue; Kinked; Aspiration Issue

  THE PATIENT WAS UNDERGOING A THROMBECTOMY PROCEDURE IN THE TIBIAL ARTERY USING AN INDIGO SYSTEM CAT5 ASPIRATION CATHETER (CAT5). DURING THE PROCEDURE, THE PHYSICIAN PLACED A NON-PENUMBRA SHEATH, THEN ADVANCED A CAT5 THROUGH THE SHEATH. AFTER TURNING THE ASPIRATION ON, NO FLOW WAS OBSERVED AND AFTER ATTEMPTING TWO PASSES WITH NO FLOW, THE CAT5 WAS REMOVED. UPON REMOVAL, IT WAS NOTICED THAT THE TIP OF THE CAT5 WAS KINKED. THE PROCEDURE WAS COMPLETED USING A NEW CAT5 AND THE SAME SHEATH. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7657361 ↗
• MalfunctionApr 27, 2018Kinked; Device Damaged Prior to Use; Kinked; Device Damaged Prior to Use

  DURING PREPARATION FOR A THROMBECTOMY PROCEDURE, THE HOSPITAL TECHNICIAN ACCIDENTALLY KINKED AN INDIGO SYSTEM CAT 5 ASPIRATION CATHETER (CAT5) AND, CONSEQUENTLY, WAS UNABLE TO ADVANCE A GUIDEWIRE THROUGH IT. THE DAMAGE TO THE CAT5 OCCURRED PRIOR TO USE AND, THEREFORE, IT WAS NOT USED IN THE PROCEDURE. THE PROCEDURE WAS COMPLETED USING AN INDIGO SYSTEM CAT 6 ASPIRATION CATHETER (CAT6).

  Patient problems: No Patient Involvement

  MAUDE report 7470497 ↗
• MalfunctionApr 19, 2018Bent; Failure to Advance; Bent; Failure to Advance

  THE PATIENT WAS UNDERGOING A THROMBECTOMY PROCEDURE USING AN INDIGO SYSTEM CAT5 ASPIRATION CATHETER (CAT5). DURING THE PROCEDURE, WHILE ATTEMPTING TO INSERT A CAT5 INTO A NON-PENUMBRA SHEATH, THE CAT5 WOULD NOT ADVANCE AND SUBSEQUENTLY, BECAME BENT; THEREFORE, IT WAS REMOVED. THE PROCEDURE WAS COMPLETED USING THE SAME SHEATH AND AN INDIGO SYSTEM CAT3 ASPIRATION CATHETER (CAT3). THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7445100 ↗
• MalfunctionMar 21, 2018Bent; Device Damaged Prior to Use; Device Handling Problem; Bent; Device Damaged Prior to Use; Device Handling Problem

  DURING PREPARATION FOR A MEDICAL PROCEDURE, THE HOSPITAL STAFF INADVERTENTLY KINKED THE INDIGO SYSTEM CAT5 ASPIRATION CATHETER (CAT5) ON THE BACK TABLE WHILE TAKING IT OUT OF THE HOOP. THE DAMAGE TO THE CAT5 OCCURRED PRIOR TO USE. THEREFORE, THE CAT5 WAS NOT USED IN THE PROCEDURE. THE PROCEDURE WAS COMPLETED USING A NEW CAT5.

  Patient problems: No Patient Involvement

  MAUDE report 7360119 ↗
• MalfunctionFeb 5, 2018Break; Device Damaged Prior to Use; Out-Of-Box Failure; Break; Device Damaged Prior to Use; Out-Of-Box Failure

  DURING PREPARATION FOR A THROMBECTOMY PROCEDURE USING AN INDIGO SYSTEM CAT5 ASPIRATION CATHETER (CAT5), THE SCRUB TECHNICIAN REMOVED THE CAT5 FROM THE STERILE PACKAGE AND NOTICED THAT THE CATHETER WAS BROKEN. THE DAMAGE TO THE CAT5 WAS FOUND PRIOR TO USE; THEREFORE IT WAS NOT USED IN THE PROCEDURE. THE PROCEDURE WAS COMPLETED USING A NEW CAT5.

  Patient problems: No Patient Involvement

  MAUDE report 7240827 ↗
• MalfunctionJan 12, 2018Break; Kinked; Device Damaged Prior to Use; Break; Kinked; Device Damaged Prior to Use

  DURING PREPARATION FOR A THROMBECTOMY PROCEDURE, THE SCRUB TECHNOLOGIST NOTICED THAT AN INDIGO SYSTEM CAT5 ASPIRATION CATHETER (CAT5) HAD A SEVERE KINK AT THE MID SHAFT. THE CAT5 WAS KINKED/BROKEN THROUGH THE OUTER POLYMER AND THE COIL WIND WAS THE ONLY THING HOLDING THE CATHETER TOGETHER. THE DAMAGED CAT5 WAS FOUND PRIOR TO USE. THEREFORE, THE CAT5 DID NOT COME INTO CONTACT WITH THE PATIENT AND WAS NOT USED IN THE PROCEDURE. THE PROCEDURE WAS COMPLETED USING A NEW INDIGO SYSTEM ASPIRATION CATHETER 6 (CAT6).

  Patient problems: No Patient Involvement

  MAUDE report 7185088 ↗
• MalfunctionDec 28, 2017Break; Tear, Rip or Hole in Device Packaging; Break; Tear, Rip or Hole in Device Packaging

  THE PATIENT WAS UNDERGOING A THROMBECTOMY PROCEDURE IN A POPLITEAL VEIN USING AN INDIGO SYSTEM CAT5 ASPIRATION CATHETER (CAT5) AND AN INDIGO SYSTEM SEPARATOR 5 (SEP5). DURING THE PROCEDURE, WHILE USING THE SEP5 WITHIN THE CAT5, THE SEP5 PERFORATED THROUGH THE SIDE OF THE CAT5. IT WAS REPORTED THAT THIS WAS A CHRONIC CLOT, AND THOUGH THE PHYSICIAN FELT RESISTANCE WHILE USING THE SEP5 WITHIN THE VESSEL, THERE WAS NO RESISTANCE WHILE ADVANCING WITHIN THE CAT5. THE PHYSICIAN THEREFORE REMOVED THE CAT5 AND SEP5, AND ATTEMPTED TO USE A NON-PENUMBRA CATHETER TO REMOVE THE THROMBUS, HOWEVER WAS STILL UNSUCCESSFUL. THE PROCEDURE ENDED AT THIS POINT. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7151725 ↗
• MalfunctionDec 11, 2017Mechanical Jam; Mechanical Jam

  THE PATIENT WAS UNDERGOING A THROMBECTOMY PROCEDURE IN THE MESENTERIAL ARTERY USING AN INDIGO SYSTEM CAT5 ASPIRATION CATHETER AND AN INDIGO SYSTEM CAT3 ASPIRATION CATHETER. DURING THE PROCEDURE, WHILE ADVANCING THE CAT5 THROUGH A NON-PENUMBRA SHEATH, THE CAT5 BECAME STUCK AFTER BEING ADVANCED APPROXIMATELY 8-10 CENTIMETERS INTO THE SHEATH; THEREFORE, IT WAS REMOVED. THE PHYSICIAN THEN ADVANCED A CAT3 THROUGH A NON-PENUMBRA SHEATH TO THE TARGET LOCATION AND BEGAN ASPIRATION. HOWEVER, WHILE RETRACTING THE CAT3 TO REMOVE THE CLOT, THE PHYSICIAN EXPERIENCED RESISTANCE AND THE CAT3 BROKE INTO TWO PARTS APPROXIMATELY 15 CENTIMETERS FROM THE DISTAL TIP. THE BROKEN CAT3 WAS COMPLETELY REMOVED FROM THE PATIENT SINCE THE BROKEN PARTS WERE STILL CONTAINED WITHIN THE SHEATH. THE CLOT WAS NOT REMOVED AND THE PROCEDURE STOPPED AT THAT POINT. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT. AFTERWARDS THE PATIENT SUCCESSFULLY UNDERWENT VASCULAR SURGERY TO REMOVE THE CLOT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7104428 ↗
• MalfunctionNov 17, 2017Collapse; Device Handling Problem; Collapse; Device Handling Problem

  THE PATIENT WAS UNDERGOING A THROMBECTOMY PROCEDURE USING AN INDIGO SYSTEM CAT5 ASPIRATION CATHETER (CAT5) AND AN INDIGO SYSTEM SEPARATOR 5 (SEP5). DURING THE PROCEDURE, THE HOSPITAL TECHNICIAN ACCIDENTLY CRUSHED THE DISTAL TIP OF THE CAT5 UPON INSERTION INTO THE NON-PENUMBRA SHEATH AND THEREFORE, THE CAT5 WAS REMOVED. A NEW CAT5 WAS THEN INSERTED, AND THE PHYSICIAN CONTINUED THE PROCEDURE USING A SEP5 WITHIN THE CAT5. WHILE IN USE, THE BULB OF THE SEP5 BECAME BROKEN WHILE IN USE INSIDE THE PATIENT, HOWEVER THE BULB DID NOT FULLY DETACH FROM THE PUSHER WIRE. THE PHYSICIAN THEREFORE WAS ABLE TO REMOVE THE SEP5 AND THE BULB BY SIMPLY RETRACTING THE SEP5. THE PROCEDURE WAS THEN COMPLETED USING THE SAME CAT5 AND A NEW SEP5. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7042964 ↗
• MalfunctionNov 10, 2017Break; Complete Blockage; Break; Complete Blockage

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

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7022327 ↗
• MalfunctionSep 26, 2017Stretched; Stretched

  THE PATIENT WAS UNDERGOING A THROMBECTOMY PROCEDURE IN THE POPLITEAL AND PROFUNDA FEMORIS ARTERIES USING AN INDIGO SYSTEM CAT5 ASPIRATION CATHETER (CAT5) AND AN INDIGO SYSTEM SEPARATOR 5 (SEP5). DURING THE PROCEDURE, THE CAT5 WAS REMOVED TO BE FLUSHED WITH THE SEP5 INSIDE; HOWEVER UPON REMOVAL THE PHYSICIAN NOTICED THAT THE CAT5 APPEARED TO BE STRETCHED. THE PROCEDURE WAS THEREFORE COMPLETED USING A NEW CAT5 AND NEW SEP5. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6894658 ↗
• MalfunctionAug 10, 2017Physical Resistance; Aspiration Issue; Difficult to Advance; Physical Resistance; Aspiration Issue; Difficult to Advance

  THE PATIENT WAS UNDERGOING A THROMBECTOMY PROCEDURE IN THE PERONEAL ARTERY USING AN INDIGO SYSTEM CAT5 ASPIRATION CATHETER (CAT5). DURING THE PROCEDURE, THE PHYSICIAN MADE TWO SUCCESSFUL PASSES USING THE CAT5 THROUGH A NON-PENUMBRA 6F SHEATH, THEN HAD DIFFICULTY CROSSING A SECTION AND NOTICED THAT NOTHING WAS BEING ASPIRATED. IT WAS REPORTED THAT THE PHYSICIAN ENCOUNTERED RESISTANCE HALF WAY DOWN THE MID-ANTERIOR TIBIAL ARTERY. THE PHYSICIAN THEN RETRACTED THE CAT5 TO FLUSH AND NOTICED THAT IT WAS SEVERELY KINKED. THEREFORE, THE PROCEDURE WAS COMPLETED USING A NEW CAT5 AND THE SAME SHEATH. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6786891 ↗
• MalfunctionFeb 17, 2017Kinked; Physical Resistance; Kinked; Physical Resistance

  THE PATIENT WAS UNDERGOING A THROMBECTOMY PROCEDURE IN THE SUPERFICIAL FEMORAL ARTERY (SFA) OF THE LEFT LEG USING AN INDIGO SYSTEM CAT5 ASPIRATION CATHETER (CAT5) AND AN INDIGO SYSTEM SEPARATOR 5 (SEP5). DURING THE PROCEDURE, WHILE ATTEMPTING TO ADVANCE THE CAT5 WITH THE SEP5 INSIDE FOR THE FIRST PASS, THE PHYSICIAN EXPERIENCED RESISTANCE AND SUBSEQUENTLY, THE DISTAL TIP OF THE CAT5 BECAME KINKED. THEREFORE, THE PHYSICIAN WAS UNABLE TO ADVANCE OR RETRACT THE SEP5 AND DECIDED TO REMOVE THE ENTIRE SYSTEM AND END THE PROCEDURE AT THAT POINT. UPON REMOVAL OF SEP5 FROM THE CAT5, IT WAS OBSERVED THAT THE SEP5 WAS STRETCHED DUE TO THE KINKED CAT5. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6341096 ↗
• MalfunctionDec 20, 2016Collapse; Aspiration Issue; Collapse; Aspiration Issue

  THE PATIENT WAS UNDERGOING A THROMBECTOMY PROCEDURE IN THE SUPERIOR MESENTERIC ARTERY (SMA) USING AN INDIGO SYSTEM CAT5 ASPIRATION CATHETER (CAT5). DURING THE PROCEDURE, UPON INITIATION OF ASPIRATION, IT WAS REPORTED THAT THE CAT5 COLLAPSED FLAT AND DID NOT ASPIRATE THE CLOT AT ALL. THEREFORE, THE CAT5 WAS REMOVED. THE PATIENT THEN UNDERWENT OPEN ABDOMINAL SURGERY TO REMOVE THE CLOT AND PARTIALLY EFFECTED ORGANS. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6191798 ↗
• MalfunctionAug 22, 2016Inadequacy of Device Shape and/or Size; Stretched; Physical Resistance; Inadequacy of Device Shape and/or Size; Stretched; Physical Resistance

  THE PATIENT WAS UNDERGOING A THROMBECTOMY PROCEDURE USING AN INDIGO SYSTEM CAT5 ASPIRATION CATHETER (CAT5). DURING THE PROCEDURE, WHILE ATTEMPTING TO ADVANCE THE CAT5 THROUGH A NON-PENUMBRA SHEATH, THE PHYSICIAN EXPERIENCED RESISTANCE AND WAS UNABLE TO ADVANCE THE CAT5; THEREFORE, IT WAS REMOVED. UPON REMOVING THE CAT5, THE PHYSICIAN NOTICED IT WAS TOO BIG FOR THE SHEATH AND IT BECAME FLATTENED AND STRETCHED. THE PROCEDURE WAS SUCCESSFULLY COMPLETED USING AN INDIGO SYSTEM CAT 3 ASPIRATION CATHETER AND A LARGER NON-PENUMBRA SHEATH. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 5895199 ↗
• MalfunctionJul 13, 2016Fracture; Fracture

  THE PATIENT WAS UNDERGOING A THROMBECTOMY PROCEDURE IN THE SUPERFICIAL FEMORAL ARTERY (SFA) USING AN INDIGO SYSTEM CAT5 ASPIRATION CATHETER (CAT5). DURING THE PROCEDURE, THE PHYSICIAN DID NOT ENCOUNTER ANY FRICTION WHILE USING THE CAT5 BUT INDICATED THAT IT WAS TIGHT BECAUSE OF THE VALVE. HOWEVER, THEY WERE ABLE TO ADVANCE THE CAT5 THROUGH THE OTHER MANUFACTURER'S SHEATH USING THE PEELABLE SHEATH. WHILE REMOVING THROMBUS IN A SEGMENT OF THE SFA, THE PHYSICIAN FELT THAT THE THROMBUS WAS INVESTED IN THE CAT5 AND BEGAN TO RETRACT THE CAT5 WITH THE ASPIRATION ON. WHILE RETRACTING THE CAT5 FROM THE SHEATH, THE PHYSICIAN NOTICED UNDER FLOUROSCOPY, THAT THE CAT5 APPEARED TO BE FRACTURED. THE PHYSICIAN WAS THEN ABLE TO REMOVE THE CAT5 FROM THE PATIENT AND CONFIRMED THAT THE THROMBUS WAS INSIDE THE CAT5 AND THAT THE CAT5 WAS INDEED FRACTURED. THE PROCEDURE WAS SUCCESSFULLY COMPLETED AT THIS POINT. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 5792357 ↗
• MalfunctionMay 23, 2016Break; Kinked; Device Damaged Prior to Use; Out-Of-Box Failure; Break; Kinked; Device Damaged Prior to Use; Out-Of-Box Failure

  DURING PREPARATION FOR A THROMBECTOMY PROCEDURE, THE HOSPITAL STAFF FOUND THAT THE INDIGO SYSTEM CAT5 ASPIRATION CATHETER (CAT5) WAS KINKED UPON REMOVAL FROM THE PACKAGING. THE DAMAGED CAT5 WAS FOUND PRIOR TO USE AND THEREFORE, WAS NOT USED FOR THE PROCEDURE. THE PROCEDURE WAS COMPLETED USING A NEW CAT5.

  Patient problems: No Patient Involvement

  MAUDE report 5674244 ↗