MAUDE Adverse Event Report: PENUMBRA, INC. INDIGO SYSTEM ASPIRATION CATHETER 8; DXE

Catalog Number	CAT8TORQ85
Medical Device Problem Codes	Failure to Advance (2524); Aspiration Issue (2883)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	08/24/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Results: the indigo system aspiration catheter 8 (cat8) was kinked approximately 23.0, 41.0, and 76.0 cm from the hub.The distal tip was ovalized in multiple locations.The cat8 was bent along its length.Conclusions: evaluation of the returned device revealed the distal tip was ovalized in multiple locations.The wide ovalized on the distal tip was likely due to a pinching or gripping force while handling the device.If an attempt is made to advance a damaged device into a parent vessel, resistance may be experienced.Upon successfully advancing into the second non-penumbra sheath, the distal ovalizations likely contributed to the inability to aspirate through the cat8.Further evaluation revealed kinks and bends along the length of the cat8 shaft.These damages were likely incidental and a result of the return condition of the device.The non-penumbra sheaths mentioned in the complaint were not returned for evaluation.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.
Event or Problem Description
The patient was undergoing a thrombectomy procedure using an indigo system aspiration catheter 8 (cat8).During the procedure, the physician attempted to advance the cat8 through a non-penumbra sheath, however was unable to.The physician therefore removed the cat8 and the sheath, and inserted a new non-penumbra sheath.The physician was then able to advance the cat8 into the target location, but found that the cat8 was unable to aspirate; therefore, the cat8 was removed.The procedure was completed using an indigo system aspiration catheter 6 (cat6) and the same non-penumbra sheath.There was no report of an adverse effect to the patient.
Additional Manufacturer Narrative
Please note that the following section was incorrectly reported on the initial mfr report and is being corrected on this follow-up #01 mfr report: 1.Box 5.510(k).

• Brand Name: INDIGO SYSTEM ASPIRATION CATHETER 8
• Common Device Name: DXE
• Manufacturer (Section D): PENUMBRA, INC.; one penumbra place; alameda CA 94502
• MDR Report Key: 6870818
• Report Number: 3005168196-2017-01602
• Device Sequence Number: 10985520
• Product Code: DXE
• UDI-Device Identifier: 00814548016252
• UDI-Public: 00814548016252
• Combination Product (Y/N): Y
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K160533
• 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): 08/24/2017
• 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: Physician
• Device Expiration Date: 04/20/2020
• Device Catalogue Number: CAT8TORQ85
• Device Lot Number: F75821
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/30/2017
• Was the Report Sent to FDA?: Yes
• Date Report to Manufacturer: 01/10/2005
• Initial Date Received by Manufacturer: 08/24/2017
• Supplement Date Received by Manufacturer: 01/14/2005
• Initial Report FDA Received Date: 09/15/2017
• Supplement Report FDA Received Date: 03/26/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 64 YR
• Date Report Sent to FDA: 01/01/2005