MAUDE Adverse Event Report: PENUMBRA, INC. INDIGO SYSTEM ASPIRATION CATHETER 6; QEW

Model Number	CAT6KIT-A
Medical Device Problem Codes	Material Deformation (2976); Physical Resistance/Sticking (4012)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/27/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The product was not returned for evaluation.Without the return of the device, the root cause of the problem cannot be determined.The manufacturing records for this lot were reviewed and did not reveal any outstanding discrepancies, design, or quality concerns.This report is associated with mfr report number: 3005168196-2021-02345.
Event or Problem Description
The patient was undergoing a thrombectomy procedure in the left superficial femoral artery (sfa) and popliteal artery using indigo system aspiration catheter 6s (cat6), a non-penumbra catheter, a non-penumbra sheath, and a guidewire.During the procedure, the physician aspirated some clot using the non-penumbra catheter.Then, the physician advanced a cat6 to the target vessel through the sheath.It is unknown if a peel away sheath was used with the cat6.Subsequently, the physician aspirated and removed clot using the cat6.Upon removal of the cat6, the physician noticed the cat6 was kinked at the distal end.It was also reported that the physician flushed and wiped the cat6 with saline prior to insertion and that the cat6 was not advancing as well as normal.Next, while advancing another cat6 to the target vessel through the sheath using the peel away sheath, the physician experienced resistance.Subsequently, the physician kinked the cat6 at the distal end.Therefore, the cat6 was removed.It was reported that the physician flushed and wiped the cat6 with saline prior to insertion.The procedure was completed using the previously used non-penumbra catheter and another non-penumbra sheath.It was reported that the patient was taken to surgery for a femoral-popliteal bypass graft placement due to the non-penumbra catheter perforating the popliteal artery.There was no report of an adverse effect to the patient related to the use of the indigo aspiration system.

• Brand Name: INDIGO SYSTEM ASPIRATION CATHETER 6
• Common Device Name: QEW
• Manufacturer (Section D): PENUMBRA, INC.; one penumbra place; alameda CA 94502
• MDR Report Key: 12675173
• Report Number: 3005168196-2021-02346
• Device Sequence Number: 1181347
• Product Code: QEW
• UDI-Device Identifier: 00815948020405
• UDI-Public: 00815948020405
• Combination Product (Y/N): Y
• Initial Reporter State: MO
• Initial Reporter Country: US
• PMA/510(K) Number: K192833
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 10/21/2021
• Report Date (Section F): 01/01/2005

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 06/14/2024
• Device Model Number: CAT6KIT-A
• Device Catalogue Number: CAT6KIT
• Device Lot Number: F107084
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Date Report to Manufacturer: 01/10/2005
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/27/2021
• Initial Report FDA Received Date: 10/21/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 71 YR
• Date Report Sent to FDA: 01/01/2005