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

Model Number	BMK6F105M
Medical Device Problem Code	Material Deformation (2976)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/21/2021
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 basilar artery (ba) using a benchmark 6f 071 delivery catheter (benchmark).During the procedure, the physician advanced the benchmark into the patient via direct stick.However, it was noticed under fluoroscopy that the distal end of the benchmark had multiple kinks.Therefore, the benchmark was removed.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 kinks in its distal shaft.If the device is forcefully advanced against resistance during insertion into a patient without a parent catheter, damage such as this may occur.Further evaluation of the device revealed distal tip ovalization.This damage was likely a result of forceful mishandling of the device during the procedure.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: 12186818
• Report Number: 3005168196-2021-01585
• Device Sequence Number: 1480311
• Product Code: DQY
• UDI-Device Identifier: 00814548014043
• UDI-Public: 00814548014043
• Combination Product (Y/N): Y
• Initial Reporter Country: AS
• PMA/510(K) Number: K142321
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 10/19/2021
• 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: 02/22/2024
• Device Model Number: BMK6F105M
• Device Catalogue Number: BMK6F105M
• Device Lot Number: F104054
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/21/2021
• Was the Report Sent to FDA?: Yes
• Date Report to Manufacturer: 01/10/2005
• Initial Date Received by Manufacturer: 06/22/2021
• Supplement Date Received by Manufacturer: 10/01/2021
• Initial Report FDA Received Date: 07/18/2021
• Supplement Report FDA Received Date: 10/19/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 63 YR
• Date Report Sent to FDA: 01/01/2005