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

Catalog Number	BMK6F105M
Medical Device Problem Codes	Kinked (1339); Physical Resistance (2578)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	04/09/2018
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 medical procedure using a benchmark 6f 071 delivery catheter (benchmark).During the procedure, while attempting to load a benchmark into the patient, the physician experienced resistance and decided to remove it.The physician also experienced resistance while removing the benchmark and upon pulling harder to remove the benchmark, the physician noticed a kink on the benchmark.The procedure was completed using a new benchmark.There was no report of an adverse effect to the patient.
Additional Manufacturer Narrative
Results: the benchmark was kinked approximately 68.0, 103.0, and 105.5 cm from the hub.The benchmark was ovalized approximately 43.0, 82.0, and 107.0-110.0 cm from the hub.Bends were seen along the length of the device.The benchmark was damaged, and, therefore, functional testing was unable to be performed.Conclusions: evaluation of the returned benchmark revealed distal kinks and ovalizations on the device.This damage was likely a result of mishandling during preparation or forceful advancement against resistance.Further evaluation revealed bends along the length of the device.Based on the return condition, the bends, some ovalizations, and some of kinks were likely incidental to the complaint and may have occurred during packaging for return to penumbra.Penumbra catheters 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: DQY
• Manufacturer (Section D): PENUMBRA, INC.; one penumbra place; alameda CA 94502
• MDR Report Key: 7491256
• Report Number: 3005168196-2018-00936
• Device Sequence Number: 18881194
• Product Code: DQY
• UDI-Device Identifier: 00814548014043
• UDI-Public: 00814548014043
• Combination Product (Y/N): Y
• Initial Reporter Country: UK
• 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): 04/09/2018
• 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: Physician
• Device Expiration Date: 11/09/2020
• Device Catalogue Number: BMK6F105M
• Device Lot Number: F80504
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/07/2018
• Was the Report Sent to FDA?: Yes
• Date Report to Manufacturer: 01/10/2005
• Initial Date Received by Manufacturer: 04/09/2018
• Supplement Date Received by Manufacturer: 07/02/2018
• Initial Report FDA Received Date: 05/07/2018
• Supplement Report FDA Received Date: 07/31/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Date Report Sent to FDA: 01/01/2005