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

Model Number	BMK6F105BER130
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	02/19/2020
Type of Reportable Event	Serious Injury
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 coil embolization procedure in the anterior communicating artery (aca) using a benchmark 6f 071 delivery catheter (benchmark), non-penumbra microcatheter and, non-penumbra sheath.During the procedure, after completion of coiling an aneurysm, the physician removed the microcatheter and began to retract the benchmark to remove it.However, while retracting, the distal end of the benchmark had broken off.The physician then used a snare device to capture the broken piece of the benchmark and retract it down to the sheath, however, the physician was unable to retract the snare device back into the sheath.Therefore, the physician performed a femoral artery cutdown surgery to remove the broken piece of the benchmark.It was noted that a retroperitoneal bleed occurred and, subsequently, was resolved.
Additional Manufacturer Narrative
Results: the returned benchmark was fractured approximately 50.0 cm from the hub.Kinks were present along the length of the catheter.Conclusions: evaluation of the returned benchmark confirmed a mid-shaft fracture.There was no stretching on either end of the fracture and the material was folding backwards.This indicates this fracture as likely the result of a kink.If the device is advanced against resistance, the catheter may become kinked.Subsequently retracting the damaged catheter may result in the device fracture.The non-penumbra sheath used in the procedure was not returned for evaluation.Further investigation revealed kinks along the length of the benchmark.These kinks were likely incidental to the complaint and could have occurred during removal from the patient.Penumbra coils 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.

• 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: 9849757
• Report Number: 3005168196-2020-00381
• Device Sequence Number: 19023912
• Product Code: DQY
• UDI-Device Identifier: 00814548014029
• UDI-Public: 00814548014029
• Combination Product (Y/N): Y
• Initial Reporter State: KY
• 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): 02/24/2020
• 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?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 09/24/2022
• Device Model Number: BMK6F105BER130
• Device Catalogue Number: BMK6F105BER130
• Device Lot Number: F93279
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/26/2020
• Was the Report Sent to FDA?: Yes
• Date Report to Manufacturer: 01/10/2005
• Initial Date Received by Manufacturer: 02/24/2020
• Supplement Date Received by Manufacturer: 04/29/2020
• Initial Report FDA Received Date: 03/18/2020
• Supplement Report FDA Received Date: 05/14/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 77 YR
• Date Report Sent to FDA: 01/01/2005