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

Catalog Number	BMK6F105MBER130
Medical Device Problem Codes	Kinked (1339); Device Damaged Prior to Use (2284); Out-Of-Box Failure (2311)
Health Effect - Clinical Code	No Patient Involvement (2645)
Date of Event	10/17/2016
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Results: the benchmark 6f 071 delivery catheter (benchmark) was kinked approximately 15.0, 35.0, 47.0, and 86.0 cm from the hub.The benchmark displayed various damage along its length.Conclusions: evaluation of the device revealed the benchmark was bent and kinked in multiple locations.This type of damage can occur as a result of mishandling when removing the benchmark from its packaging.The multiple instances of bends and kinks found on the benchmark suggests that additional damage may have been incurred on the benchmark catheter after discovering kinked benchmark out-of-box.This damage was likely incidental and likely occurred during handling and packaging for return to penumbra facilities.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
During preparation for a medical procedure, a benchmark 6f 071 delivery catheter (benchmark dc) shaft was kinked upon removal from its dispenser hoop.The kinking of the benchmark dc shaft occurred prior to use and therefore it was not used in the procedure.The procedure was successfully completed using a new benchmark dc.

• 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: 6105685
• Report Number: 3005168196-2016-01612
• Device Sequence Number: 16296577
• Product Code: DQY
• UDI-Device Identifier: 00814548014050
• UDI-Public: 00814548014050
• Combination Product (Y/N): N
• Initial Reporter State: CA
• 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
• Report Date (Section B): 10/17/2016

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: 04/21/2019
• Device Catalogue Number: BMK6F105MBER130
• Device Lot Number: F69058
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/27/2016
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/17/2016
• Initial Report FDA Received Date: 11/16/2016
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1