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

Model Number	BMK6F95MBER120
Medical Device Problem Codes	Break (1069); Material Deformation (2976)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	02/10/2020
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 in the middle cerebral artery (mca) using a benchmark 6f 071 delivery catheter (benchmark) and non-penumbra sheath.During the procedure, while placing the benchmark in the patient, the physician noticed the proximal section near the hub of the benchmark became ovalized and broken.Therefore, the benchmark was removed.The procedure was completed using a new benchmark and the same sheath.There was no report of an adverse effect to the patient.
Additional Manufacturer Narrative
Results: the returned benchmark was fractured at approximately 5.0 cm from the hub.The device was kinked at approximately 67.0 cm from the hub.Conclusions: evaluation of the returned benchmark confirmed a fracture on its proximal end.If the device is forcefully advanced against resistance or otherwise manipulated at extreme angles outside the patient body, damage such as a kink and subsequent a fracture may occur.Further evaluation revealed a kink on the midshaft.This kink was likely incidental to the complaint.Penumbra catheters are inspected during in-process inspection and during quality inspection after manufacturing.The product lot number was not provided, therefore, the manufacturing records could not be reviewed.

• 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: 9802308
• Report Number: 3005168196-2020-00317
• Device Sequence Number: 642897
• Product Code: DQY
• UDI-Device Identifier: 00814548014173
• UDI-Public: 00814548014173
• Combination Product (Y/N): Y
• 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,Followup
• Report Date (Section B): 02/13/2020
• 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 Model Number: BMK6F95MBER120
• Device Catalogue Number: BMK6F95MBER120
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/09/2020
• Was the Report Sent to FDA?: Yes
• Date Report to Manufacturer: 01/10/2005
• Initial Date Received by Manufacturer: 02/13/2020
• Supplement Date Received by Manufacturer: 03/30/2020
• Initial Report FDA Received Date: 03/06/2020
• Supplement Report FDA Received Date: 04/21/2020
• 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