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

Catalog Number	BMK6F95M
Medical Device Problem Codes	Bent (1059); Device Damaged Prior to Use (2284); Out-Of-Box Failure (2311)
Health Effect - Clinical Code	No Patient Involvement (2645)
Date of Event	06/29/2016
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The benchmark 6f 071 delivery catheter (benchmark dc) was kinked approximately 44.5 cm from the hub.Evaluation of the returned device revealed that the benchmark dc was kinked.This type of damage likely occurs due to improper handling during removal from the packaging.If the device is forcefully retracted at an angle during removal from the packaging, damage such as this may occur.Benchmark dc devices are 100% visually inspected during in-process inspection.The manufacturing records for this lot were reviewed and did not reveal any outstanding discrepancies, design, or quality concerns.
Event or Problem Description
During preparation for a medical procedure, the hospital staff noticed that the mid section of the benchmark 6f 071 delivery catheter (benchmark dc) was bent upon removal from the packaging.The bent benchmark dc was found prior to use and therefore, was not used for the procedure.The procedure was completed using a new benchmark dc.

• 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: 5835061
• Report Number: 3005168196-2016-01081
• Device Sequence Number: 521653
• Product Code: DQY
• UDI-Device Identifier: 00814548014166
• UDI-Public: 00814548014166
• Combination Product (Y/N): N
• 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: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 06/29/2016

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: 12/29/2018
• Device Catalogue Number: BMK6F95M
• Device Lot Number: F67115
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/18/2016
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/29/2016
• Initial Report FDA Received Date: 07/29/2016
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1