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

Model Number	BMK6F95MBER120
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	06/08/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device has been returned and the investigation results are pending.A follow up mdr will be submitted upon completion of the device investigation.
Event or Problem Description
The patient was undergoing a coil embolization procedure in the anterior cerebral artery (aca) using a benchmark 6f 071 delivery catheter (benchmark) and a non-penumbra 7f sheath.During the procedure, after advancing the benchmark into the patient using the 7f sheath, the physician noticed bleeding at the puncture site.Upon checking, it was noticed that the benchmark was broken at the hub; therefore, it 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 1.0 cm from the hub.The device was kinked approximately 37.0 cm, 41.0 cm, 47.0 cm and 99.0 cm from the hub.Conclusions: evaluation of the returned benchmark confirmed a fracture near its proximal end underneath the strain relief.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 kink along the catheter.These kinks were likely incidental to the complaint and could 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.

• 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: 10222924
• Report Number: 3005168196-2020-00875
• Device Sequence Number: 13587250
• 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): 06/08/2020
• 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: 02/18/2023
• Device Model Number: BMK6F95MBER120
• Device Catalogue Number: BMK6F95MBER120
• Device Lot Number: F96319
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/17/2020
• Was the Report Sent to FDA?: Yes
• Date Report to Manufacturer: 01/10/2005
• Initial Date Received by Manufacturer: 06/08/2020
• Supplement Date Received by Manufacturer: 07/09/2020
• Initial Report FDA Received Date: 07/02/2020
• Supplement Report FDA Received Date: 07/20/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 59 YR
• Date Report Sent to FDA: 01/01/2005