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

Catalog Number	BMK6F105MBER130
Medical Device Problem Codes	Kinked (1339); Failure to Advance (2524); Device Operates Differently Than Expected (2913)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	06/01/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
B)(4).Results: the benchmark 6f 071 delivery catheter (benchmark) was severely kinked approximately 102.0 cm from the hub.The benchmark was kinked in multiple locations.Conclusion: evaluation of the returned device confirmed that the benchmark 6f 071 delivery catheter (benchmark) was severely kinked.This type of damage typically occurs due to improper handling during use.If the peelable sheath is not used to protect the distal tip of the catheter during insertion, damage such as kinks may occur.Further evaluation of the returned devices revealed that the select catheter was stuck inside the benchmark.The multiple kinks along the catheter shaft of the benchmark likely contributed to the select catheter getting stuck inside the benchmark.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.
Event or Problem Description
The patient was undergoing a medical procedure using a benchmark 6f 071 delivery catheter (benchmark).During the procedure, the physician felt resistance upon insertion of the benchmark into the introducer sheath, and subsequently the distal tip of the benchmark became severely kinked; therefore, the benchmark was removed.The procedure was completed using a new catheter.There was no report of an adverse effect to the patient.
Additional Manufacturer Narrative
Please note that box 10/11 is being corrected.First line of conclusion is changed from "evaluation of the returned device confirmed that the benchmark 6f 071 delivery catheter (benchmark) was severely kinked." to "evaluation of the returned device confirmed that the benchmark 6f 071 delivery catheter (benchmark) was severely kinked and the select catheter was stuck inside.".

• Brand Name: BENCHMARK 6F 071 DELIVERY CATHETER (BENCHMARK)
• Common Device Name: DQY
• Manufacturer (Section D): PENUMBRA, INC.; one penumbra place; alameda CA 94502
• MDR Report Key: 6772060
• Report Number: 3005168196-2017-01357
• Device Sequence Number: 1242981
• Product Code: DQY
• UDI-Device Identifier: 00814548014050
• UDI-Public: 00814548014050
• Combination Product (Y/N): N
• Initial Reporter Country: TC
• PMA/510(K) Number: K142321
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,distri
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 07/16/2017

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: 01/06/2020
• Device Catalogue Number: BMK6F105MBER130
• Device Lot Number: F73530
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/27/2017
• Initial Date Received by Manufacturer: 07/16/2017
• Supplement Date Received by Manufacturer: 07/16/2017
• Initial Report FDA Received Date: 08/07/2017
• Supplement Report FDA Received Date: 08/22/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1