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

Model Number	BMK6F115M
Medical Device Problem Codes	Failure to Advance (2524); Material Deformation (2976)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/08/2021
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 ophthalmic segment of the right internal carotid artery using a benchmark 6f 071 delivery catheter (benchmark) and a non-penumbra long sheath.During the procedure, the physician experienced resistance while inserting the benchmark into the long sheath and subsequently, the distal tip of the benchmark became damaged.Therefore, the benchmark and catheter were removed.The procedure was completed using a new benchmark and another sheath.There was no report of an adverse effect to the patient.
Additional Manufacturer Narrative
Please note that the following section is being updated based on additional information provided by a penumbra distributor on 08/16/2021.Evaluation of the returned benchmark revealed that the distal shaft was ovalized.If the peel-away sheath, provided with the benchmark, is not properly utilized prior to advancement of the device into a parent device, damage such as ovalizations may occur.During functional testing, resistance was experienced while attempting to advance the benchmark through a demonstration neuron max due to the ovalization on the distal shaft and the benchmark could not advance any further.Further evaluation revealed an ovalization on the proximal end and kinks.This damage was likely incidental to the reported complaint and the root cause could not be determined.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.
Event or Problem Description
The patient was undergoing a medical procedure in the ophthalmic segment of the right internal carotid artery using a benchmark 6f 071 delivery catheter (benchmark) and a non-penumbra long sheath.During the procedure, the physician experienced resistance while attempting to insert the benchmark into the long sheath and subsequently, the distal tip of the benchmark became ovalized.It was reported that the benchmark could not be advanced into the sheath.Therefore, the benchmark and sheath were removed.The procedure was completed using a new benchmark and another sheath.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: 12277948
• Report Number: 3005168196-2021-01751
• Device Sequence Number: 19858897
• Product Code: DQY
• UDI-Device Identifier: 00814548014104
• UDI-Public: 00814548014104
• Combination Product (Y/N): Y
• Initial Reporter Country: BR
• PMA/510(K) Number: K142321
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: distributor,foreign,health pr
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 08/31/2021
• 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: 09/28/2023
• Device Model Number: BMK6F115M
• Device Catalogue Number: BMK6F115M
• Device Lot Number: F100601
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/10/2021
• Was the Report Sent to FDA?: Yes
• Date Report to Manufacturer: 01/10/2005
• Initial Date Received by Manufacturer: 07/13/2021
• Supplement Date Received by Manufacturer: 08/25/2021
• Initial Report FDA Received Date: 08/04/2021
• Supplement Report FDA Received Date: 08/31/2021
• 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