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

Catalog Number	BMK6F95M
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/19/2022
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 percutaneous transluminal angioplasty (pta) procedure to treat an artery spasm of the internal carotid artery (ica) using a benchmark 6f 071 delivery catheter (benchmark).During the procedure, the physician placed the benchmark in the patient.Afterwards, the physician could not inject contrast via the benchmark; therefore, the physician checked the benchmark.Subsequently, the physician noticed that the benchmark was leaking at the mid-shaft.Therefore, the benchmark was removed.It was reported that upon removal, a cut was observed where the benchmark was leaking.The procedure was completed using a new benchmark.There was no report of an adverse effect to the patient.
Additional Manufacturer Narrative
Evaluation of the returned benchmark confirmed that the catheter was fractured.If the benchmark is advanced at angle during use, damage such as a kink and subsequent fracture may occur.This damage likely contributed to the reported leak during the procedure.Further evaluation revealed a kink on the proximal shaft and ovalization on the distal shaft.This damage was incidental to the reported complaint.The kink on the proximal shaft likely occurred during packaging of the device for return to penumbra.The ovalization in the distal shaft was inadvertently done by the penumbra evaluation technician during decontamination.Penumbra products are visually 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: QJP
• Manufacturer (Section D): PENUMBRA, INC.; one penumbra place; alameda CA 94502
• Manufacturer Contact: veronica farris ; one penumbra place; alameda, CA 94502 ; 5107483200
• MDR Report Key: 16018330
• Report Number: 3005168196-2022-00581
• Device Sequence Number: 5858643
• Product Code: DQY
• UDI-Device Identifier: 00814548014166
• UDI-Public: 814548014166
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: K212838
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 04/05/2023
• 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: 06/28/2025
• Device Catalogue Number: BMK6F95M
• Device Lot Number: F00001775
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report to Manufacturer: 01/10/2005
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/23/2022
• Supplement Date Received by Manufacturer: 03/09/2023
• Initial Report FDA Received Date: 12/20/2022
• Supplement Report FDA Received Date: 04/05/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/29/2022
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown
• Date Report Sent to FDA: 01/01/2005