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

Catalog Number	BMK6F105BER130
Medical Device Problem Codes	Retraction Problem (1536); Physical Resistance (2578); Material Deformation (2976)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	09/06/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Results: the benchmark 6f 071 delivery catheter (benchmark) was compressed and had multiple consecutive kinks along the length of its distal shaft, beginning approximately 102.0 cm from the hub.The non-penumbra catheter was deformed on its distal end, with the non-penumbra distal protection device advanced out of its distal tip.Conclusion: evaluation of the returned devices revealed that the benchmark was compressed and had multiple consecutive kinks in its distal shaft, and the distal end of the non-penumbra catheter was deformed.The damage observed on the distal end of the benchmark likely occurred as a result of attempting to withdraw the deformed non-penumbra catheter and distal protection device through the benchmark.Further compression and damage were observed when attempting to retract the devices through the benchmark during functional analysis.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 carotid stenting procedure using a benchmark 6f 071 delivery catheter (benchmark).During the procedure, the physician deployed a distal protection device through the benchmark.The physician then felt resistance and was unable to retract the distal protection device into the benchmark; therefore the benchmark and distal protection device were removed together and the procedure was ended.Upon removal, it was found that the tip of the benchmark was scrunched and the lumen was compromised.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: 6904413
• Report Number: 3005168196-2017-01704
• Device Sequence Number: 10878034
• Product Code: DQY
• UDI-Device Identifier: 00814548014029
• UDI-Public: 00814548014029
• Combination Product (Y/N): N
• Initial Reporter State: WI
• 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): 09/07/2017

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: Physician
• Device Expiration Date: 11/17/2019
• Device Catalogue Number: BMK6F105BER130
• Device Lot Number: F72886
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/21/2017
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/07/2017
• Initial Report FDA Received Date: 09/29/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 82 YR