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

Model Number	BMK6F105MBER130
Medical Device Problem Codes	Break (1069); Device Damaged Prior to Use (2284)
Health Effect - Clinical Code	No Patient Involvement (2645)
Date of Event	02/28/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Hold for jc.
Event or Problem Description
During preparation for a medical procedure, a benchmark delivery catheter (benchmark) was broken near the hub upon removal from its packaging.The damage to the benchmark occurred prior to use and, therefore, it was not used in the procedure.The procedure was completed using a new benchmark.
Additional Manufacturer Narrative
Results: the returned device was fractured at approximately 5.0 cm from the hub.The device was ovalized at approximately 55.0 cm, 56.0 cm, 75.0 cm, 103.0 cm and 110.0 cm from the hub.Conclusions: evaluation of the returned benchmark confirmed a fracture near the hub.If the device is forcefully retracted from the packaging hoop at extreme angles, the device may become fractured.Further investigation revealed that the device was ovalized along its length.These damages 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.
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 #02 mfr report: 3005168196-2019-00588.Section d.Box 4.Expiration date.

• 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: 8460686
• Report Number: 3005168196-2019-00588
• Device Sequence Number: 2818661
• Product Code: DQY
• UDI-Device Identifier: 00814548014050
• UDI-Public: 00814548014050
• Combination Product (Y/N): Y
• Initial Reporter State: OK
• 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,Followup
• Report Date (Section B): 02/28/2019
• 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 Expiration Date: 10/18/2021
• Device Model Number: BMK6F105MBER130
• Device Catalogue Number: BMK6F105MBER130
• Device Lot Number: F86550
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/05/2019
• Was the Report Sent to FDA?: Yes
• Date Report to Manufacturer: 01/10/2005
• Initial Date Received by Manufacturer: 02/28/2019
• Supplement Date Received by Manufacturer: 04/25/2019; 01/14/2005
• Initial Report FDA Received Date: 03/28/2019
• Supplement Report FDA Received Date: 05/21/2019; 04/24/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Date Report Sent to FDA: 01/01/2005