MAUDE Adverse Event Report: PENUMBRA, INC. BENCHMARK 6F 071 DELIVERY CATHETER; DQY

Model Number	BMK6F95BER120
Medical Device Problem Codes	Material Deformation (2976); Physical Resistance/Sticking (4012)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	06/29/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device has been returned and the investigation results are pending.A follow up mdr will be submitted upon completion of the device investigation.
Event or Problem Description
The patient was undergoing a medical procedure in the m1 segment of the right middle cerebral artery (mca) using a benchmark 6f 071 delivery catheter (benchmark) and non-penumbra sheath.During the procedure, while attempting to advance the benchmark through the sheath, the physician experience resistance and reported that the benchmark would not fit into the sheath.Consequently, the distal tip of the benchmark became ovalized and kinked.Therefore, the benchmark was removed.The physician decided to end the procedure due to unfavorable aneurysm location.There was no report of an adverse effect to the patient.
Additional Manufacturer Narrative
Results: the benchmark was kinked approximately 5.5, 8.0, 41.5, and 87.5 cm from the hub.The benchmark was ovalized approximately 77.0 and 91.0 thru 100.0 cm from the hub.Conclusions: evaluation of the returned benchmark confirmed that the distal shaft of the catheter was ovalized and kinked.If the benchmark is forcefully gripped or mishandled during insertion, damage such as ovalization may occur and resistance maybe encountered.Further advancement against resistance may result in a kink.Further evaluation of the returned benchmark revealed additional kinked on the proximal shaft.These kinks were likely incidental to the reported complaint and may have occurred during packing of the device for return.Penumbra catheters are visually inspected during in-process inspection and during quality inspection after manufacturing.The product lot number was not provided, therefore, the manufacturing records could not be reviewed.

• Brand Name: BENCHMARK 6F 071 DELIVERY CATHETER
• Common Device Name: DQY
• Manufacturer (Section D): PENUMBRA, INC.; one penumbra place; alameda CA 94502
• MDR Report Key: 10317595
• Report Number: 3005168196-2020-00995
• Device Sequence Number: 11619727
• Product Code: DQY
• UDI-Device Identifier: 00814548014128
• UDI-Public: 00814548014128
• Combination Product (Y/N): Y
• Initial Reporter State: NV
• Initial Reporter Country: US
• PMA/510(K) Number: K142321
• 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): 06/29/2020
• 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 Model Number: BMK6F95BER120
• Device Catalogue Number: BMK6F95BER120
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/06/2020
• Was the Report Sent to FDA?: Yes
• Date Report to Manufacturer: 01/10/2005
• Initial Date Received by Manufacturer: 06/29/2020
• Supplement Date Received by Manufacturer: 07/29/2020
• Initial Report FDA Received Date: 07/23/2020
• Supplement Report FDA Received Date: 08/25/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 65 YR
• Patient Weight: 68
• Date Report Sent to FDA: 01/01/2005