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

Catalog Number	BMK6F105M
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	03/06/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Results: the benchmark was kinked in multiple locations along its length.Conclusions: evaluation of the returned benchmark revealed kinks along its length.If the catheter was removed from its packaging tube at extreme angles, kinks may result.Based on the returned condition, several kinks on the device were likely incidental and may have occurred during packaging for return to penumbra.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, the hospital staff found that the benchmark 6f 071 delivery catheter (benchmark) was kinked upon removal from the packaging at the back table.The damage to the benchmark was found prior to use.Therefore, the benchmark was not used in the procedure.The procedure was completed using a new benchmark.

• Brand Name: BENCHMARK DELIVERY CATHETER
• Common Device Name: DQY
• Manufacturer (Section D): PENUMBRA, INC.; one penumbra place; alameda CA 94502
• MDR Report Key: 7399707
• Report Number: 3005168196-2018-00695
• Device Sequence Number: 19200175
• Product Code: DQY
• UDI-Device Identifier: 00814548014043
• UDI-Public: 00814548014043
• Combination Product (Y/N): N
• Initial Reporter Country: HK
• PMA/510(K) Number: K142321
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: distributor,foreign,health pr
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 03/06/2018

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: Radiologic Technologist
• Device Expiration Date: 11/09/2020
• Device Catalogue Number: BMK6F105M
• Device Lot Number: F80504
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/02/2018
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/06/2018
• Initial Report FDA Received Date: 04/05/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1