MAUDE Adverse Event Report: PENUMBRA, INC. INDIGO SYSTEM ASPIRATION CATHETER 7; QEW

Model Number	CAT7DKIT-A
Medical Device Problem Code	Material Deformation (2976)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/21/2021
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.
Event or Problem Description
The patient was undergoing a thrombectomy procedure to treat arteriovenous fistula (avf) using an indigo system aspiration catheter 7 (cat7) a non-penumbra sheath.During the procedure, the physician completed approximately 3 passes using the cat7.Afterwards, it was noticed that the distal tip of the cat7 was ovalized.The technician tried to fix the ovalized distal tip and subsequently made it worse.Therefore, the cat7 was removed.The procedure was completed using a new cat7 and the same non-penumbra sheath.There was no report of an adverse effect to the patient.
Additional Manufacturer Narrative
Evaluation of the returned cat7 confirmed that the distal tip was ovalized and revealed additional ovalizations along the catheter.If the device is mishandled during use, damage such as this may occur.Further evaluation of the device revealed that the distal tip lumen was folded.This damage was likely a result of forceful manipulation of the distal tip against resistance during the procedure.The root cause of the resistance could not be determined.During functional testing, the cat7 was tested with a demonstration pump and canister and the cat7 functioning as intended.Penumbra catheters are 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.H3 other text : placeholder.

• Brand Name: INDIGO SYSTEM ASPIRATION CATHETER 7
• Common Device Name: QEW
• Manufacturer (Section D): PENUMBRA, INC.; one penumbra place; alameda CA 94502
• MDR Report Key: 12021167
• Report Number: 3005168196-2021-01362
• Device Sequence Number: 17062322
• Product Code: QEW
• UDI-Device Identifier: 00815948023970
• UDI-Public: 00815948023970
• Combination Product (Y/N): Y
• Initial Reporter State: PA
• Initial Reporter Country: US
• PMA/510(K) Number: K193595
• 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): 07/29/2021
• 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: 01/27/2024
• Device Model Number: CAT7DKIT-A
• Device Catalogue Number: CAT7DKIT
• Device Lot Number: C25050
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/22/2021
• Was the Report Sent to FDA?: Yes
• Date Report to Manufacturer: 01/10/2005
• Initial Date Received by Manufacturer: 05/21/2021
• Supplement Date Received by Manufacturer: 07/08/2021
• Initial Report FDA Received Date: 06/17/2021
• Supplement Report FDA Received Date: 07/29/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 74 YR
• Date Report Sent to FDA: 01/01/2005