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

Catalog Number	BMK6F95
Medical Device Problem Codes	Break (1069); Unraveled Material (1664)
Health Effect - Clinical Code	No Patient Involvement (2645)
Date of Event	11/18/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Results: the returned device was fractured beneath its hypotube approximately 5.0 cm from the hub.The device had an ovalization approximately 82.0 cm from the hub.Conclusions: evaluation of the returned benchmark confirmed a fractured device.If the benchmark is forcefully retracted from its packaging hoop at extreme angles or otherwise mishandled during preparation, damage such as a fracture may occur.Further evaluation revealed an ovalization on the device.The ovalization is likely incidental to the complaint.This damage may have occurred during further mishandling or packaging for return to penumbra.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
During preparation for a medical procedure, the physician removed a benchmark 6f 071 delivery catheter (benchmark) from its packaging tube and flushed it.However, the benchmark then broke and unraveled.The damage to the benchmark occurred prior to use and, therefore, it was not used in the procedure.The procedure was completed using a new benchmark.

• 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: 8182828
• Report Number: 3005168196-2018-02474
• Device Sequence Number: 1960062
• Product Code: DQY
• UDI-Device Identifier: 00814548014111
• UDI-Public: 00814548014111
• Combination Product (Y/N): Y
• Initial Reporter State: CA
• 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): 11/20/2018
• 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: Health Professional
• Device Expiration Date: 03/12/2021
• Device Catalogue Number: BMK6F95
• Device Lot Number: F82295
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/29/2018
• Was the Report Sent to FDA?: Yes
• Date Report to Manufacturer: 01/10/2005
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/20/2018
• Initial Report FDA Received Date: 12/19/2018
• 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