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	08/09/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
This device is available for return.A follow up mdr will be submitted upon completion of the device investigation.This report is associated with mfr report number: 3005168196-2021-01940.
Event or Problem Description
The patient was undergoing a thrombectomy procedure in the superficial femoral artery (sfa) and the common popliteal artery using an indigo system aspiration catheter 6 (cat6), an indigo system aspiration catheter 8 (cat8), and a non-penumbra sheath.It was reported that the patient had heavy clot burden and was uncooperative.During the procedure, the peel-away introducer sheath was used to introduce the cat6 to the sheath.It was reported that resistance was encountered immediately upon introduction to the sheath and the distal tip of a cat6 became ovalized.Therefore, the cat6 was removed.Next, while advancing a cat8 into the sheath, the same issue occurred.Therefore, the cat8 was removed.The procedure was completed using an indigo system aspiration catheter 7 (cat7) and the same sheath.There was no report of an adverse effect to the patient.
Additional Manufacturer Narrative
Evaluation of the returned cat6 confirmed that the distal tip of the catheter was ovalized.If the cat6 is forcefully advanced against resistance during use, damage such as ovalization may occur.The root cause of resistance could not be determined.Further evaluation revealed kinks in the distal shaft.This damage was incidental to the reported complaint and likely occurred due to the forceful advancement against resistance.During the functional test, resistance was encountered due to the ovalization on the distal shaft of the cat6 while attempting to advance the catheter through a demonstration neuron max and a demonstration peel-able sheath, and no further functional testing could be performed.Penumbra catheters are visually inspected during in-process inspection and during quality inspection after manufacturing.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: 1.3005168196-2021-01940.

• 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: 12399242
• Report Number: 3005168196-2021-01939
• Device Sequence Number: 5360847
• Product Code: QEW
• UDI-Device Identifier: 00815948020405
• UDI-Public: 00815948020405
• Combination Product (Y/N): Y
• Initial Reporter State: NY
• 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,Followup
• Report Date (Section B): 09/30/2021
• 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: 04/06/2024
• Device Model Number: CAT6KIT-A
• Device Catalogue Number: CAT6KIT
• Device Lot Number: F105234
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/16/2021
• Was the Report Sent to FDA?: Yes
• Date Report to Manufacturer: 01/10/2005
• Initial Date Received by Manufacturer: 08/09/2021
• Supplement Date Received by Manufacturer: 09/09/2021
• Initial Report FDA Received Date: 08/31/2021
• Supplement Report FDA Received Date: 09/30/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 60 YR
• Patient Weight: 109
• Date Report Sent to FDA: 01/01/2005