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

Catalog Number	BMK6F95
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Patient Involvement (2645)
Date of Event	11/19/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Results: the benchmark was fractured approximately 4.5 cm from the hub.The device had bends and kinks approximately 28.0 cm, 43.0 cm, 67.0 cm and 78.0 cm from the hub.The device was ovalized approximately 99.5 cm to 100.0 cm from the hub.Conclusions: evaluation of the returned benchmark confirmed a fractured device.If the device is forcefully retracted from its packaging at extreme angles or otherwise mishandled, the device may become fractured.Further evaluation revealed kinks and an ovalization on the distal fractured segment.The kinks and ovalization were likely incidental to the reported complaint and may have occurred during 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 laid it down on the scrub table.However, when the physician went to flush it, it was discovered that the benchmark was broken in two pieces and the metal winding holding the two pieces together was exposed.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: 8187194
• Report Number: 3005168196-2018-02465
• Device Sequence Number: 16620071
• 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: 12/07/2020
• Device Catalogue Number: BMK6F95
• Device Lot Number: F80926
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/04/2018
• 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: 12/20/2018
• 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