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

Model Number	BMK6F95BER120
Medical Device Problem Code	Unraveled Material (1664)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/03/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Evaluation of the returned benchmark revealed that the distal shaft was stretched, ovalized and fractured.If the benchmark is forcefully retracted against resistance, damage such as this may occur.Resistance was experienced while attempting to retract the benchmark from the non-penumbra guidewire due to the unraveled coil winds.The guidewire was able to be carefully removed from the distal end of the benchmark; subsequently, the guidewire was advanced and retracted through a demonstration benchmark without an issue.Further evaluation of the benchmark revealed kinks throughout its length.This damage was likely incidental to the reported complaint.Penumbra coils 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.
Event or Problem Description
The patient was undergoing a medical procedure in the middle meningeal artery (mma) using a benchmark 6f 071 delivery catheter (benchmark), neuron select catheter 5f (5f select), and non-penumbra microcatheters.It was noted that the patient¿s anatomy was tortuous.During the procedure, the benchmark and 5f select were advanced into the external carotid, the physician then advanced a microcatheter into the arteriovenous fistula (avf) and injected an embolic agent.Subsequently, while removing the benchmark over the guidewire, the physician noticed the guidewire became stuck inside of the benchmark and the benchmark had started to unravel upon removal.The procedure had ended at this point.There was no report of an adverse effect to the patient.

• 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: 11904684
• Report Number: 3005168196-2021-01189
• Device Sequence Number: 19934293
• Product Code: DQY
• UDI-Device Identifier: 00814548014128
• UDI-Public: 00814548014128
• Combination Product (Y/N): Y
• Initial Reporter State: TX
• 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
• Report Date (Section B): 05/03/2021
• 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: 01/07/2024
• Device Model Number: BMK6F95BER120
• Device Catalogue Number: BMK6F95BER120
• Device Lot Number: F103150
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/07/2021
• 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: 05/03/2021
• Initial Report FDA Received Date: 05/28/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 70 YR
• Date Report Sent to FDA: 01/01/2005