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

Model Number	BMK6F115M
Medical Device Problem Code	Material Deformation (2976)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	04/15/2020
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
The patient was undergoing a medical procedure using a benchmark 6f 071 delivery catheter (benchmark).During the procedure, while advancing the benchmark into the patient, the benchmark kinked; therefore, it was removed.The procedure was completed using a new benchmark.There was no report of an adverse effect to the patient.
Additional Manufacturer Narrative
Results: the benchmark was kinked approximately 112.0 and 112.5 cm from the hub.The device had multiple ovalizations approximately 112.5 ¿ 120.0 cm from the hub.Conclusions: evaluation of the returned benchmark confirmed a kink on the distal shaft.Further evaluation revealed ovalizations on the distal shaft.If the device is forcefully pinched or gripped during handling, damage such as ovalizations may occur.During functional testing, the benchmark was unable to be advanced through the hub of a demonstration neuron max due to the ovalizations on the distal shaft.The ovalizations may have contributed to the resistance experienced during the procedure and the functional test.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.

• 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: 10175449
• Report Number: 3005168196-2020-00800
• Device Sequence Number: 2974126
• Product Code: DQY
• UDI-Device Identifier: 00814548014104
• UDI-Public: 00814548014104
• Combination Product (Y/N): Y
• Initial Reporter Country: DA
• 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): 05/28/2020
• 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 Model Number: BMK6F115M
• Device Catalogue Number: BMK6F115M
• Device Lot Number: F80925
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/02/2020
• Was the Report Sent to FDA?: Yes
• Date Report to Manufacturer: 01/10/2005
• Initial Date Received by Manufacturer: 05/28/2020
• Supplement Date Received by Manufacturer: 07/24/2020
• Initial Report FDA Received Date: 06/19/2020
• Supplement Report FDA Received Date: 08/21/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 76 YR
• Date Report Sent to FDA: 01/01/2005