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

Model Number	BMK6F95MBER120
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	01/06/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
This device is available for return.A follow up mdr will be submitted upon completion of the device investigation.
Event or Problem Description
The patient was undergoing a medical procedure using a benchmark 6f 071 delivery catheter (benchmark).During the procedure, it was reported that the benchmark became fractured near the hub.The procedure was completed using a new benchmark.There was no report of an adverse effect to the patient.
Additional Manufacturer Narrative
Results: the benchmark was fractured beneath the strain relief approximately 2.0 cm from the hub and 8.5 cm from the hub.The device was kinked approximately 9.5, 31.5, 41.0, 55.0, 58.0and 81.0 cm from the hub.Conclusions: evaluation of the returned benchmark confirmed a fracture near the hub beneath the strain relief.If the device is forcefully retracted from its packaging at extreme angles or is otherwise mishandled during use, damage such as a kink may occur.If a kinked device is further manipulated, damage such as a fracture may occur.Further evaluation revealed an additional fracture and kinks throughout the length of the device.These damages were likely incidental to the reported complaint.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.

• 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: 9662614
• Report Number: 3005168196-2020-00114
• Device Sequence Number: 3414568
• Product Code: DQY
• UDI-Device Identifier: 00814548014173
• UDI-Public: 00814548014173
• Combination Product (Y/N): Y
• Initial Reporter State: NY
• 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): 01/07/2020
• 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 Expiration Date: 08/22/2022
• Device Model Number: BMK6F95MBER120
• Device Catalogue Number: BMK6F95MBER120
• Device Lot Number: F92659
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/05/2020
• Was the Report Sent to FDA?: Yes
• Date Report to Manufacturer: 01/10/2005
• Initial Date Received by Manufacturer: 01/07/2020
• Supplement Date Received by Manufacturer: 03/05/2020
• Initial Report FDA Received Date: 02/03/2020
• Supplement Report FDA Received Date: 03/12/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 51 YR
• Date Report Sent to FDA: 01/01/2005