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

Catalog Number	BMK6F95
Medical Device Problem Codes	Leak/Splash (1354); Device Damaged Prior to Use (2284)
Health Effect - Clinical Code	No Patient Involvement (2645)
Date of Event	04/04/2018
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
During preparation for a medical procedure, the nurse removed a benchmark 6f 071 delivery catheter (benchmark) from the packaging and flushed it.The benchmark was then attached to a rotating hemostasis valve (rhv) and ready to use with no noted issue.However, when commencing continuous flush through the benchmark, the physician noticed that the benchmark was leaking around the hub.Therefore, the benchmark was not used in the procedure.The procedure was completed using a new benchmark.
Additional Manufacturer Narrative
Results: the benchmark was fractured underneath the strain relief approximately 2.5 cm from the hub.Conclusions: evaluation of the returned benchmark revealed that the catheter was fractured.This type of damage typically occurs if the device is forcefully retracted at extreme angles during removal from the packaging or general mishandling during preparation.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: 7476947
• Report Number: 3005168196-2018-00913
• Device Sequence Number: 1769478
• Product Code: DQY
• UDI-Device Identifier: 00814548014111
• UDI-Public: 00814548014111
• 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): 04/04/2018
• 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: 08/09/2020
• Device Catalogue Number: BMK6F95
• Device Lot Number: F78984
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/08/2018
• Was the Report Sent to FDA?: Yes
• Date Report to Manufacturer: 01/10/2005
• Initial Date Received by Manufacturer: 04/04/2018
• Supplement Date Received by Manufacturer: 08/09/2018
• Initial Report FDA Received Date: 05/01/2018
• Supplement Report FDA Received Date: 08/15/2018
• 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