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

Catalog Number	BMK6F105M
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	06/23/2019
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 thrombectomy procedure in the internal carotid artery (ica) using a benchmark 6f 071 delivery catheter (benchmark).During the procedure, after advancing the benchmark into the target vessel using a neuron max 6f 088 long sheath (neuron max), the physician injected contrast and noticed a loss of continuity of the shaft of the benchmark.Therefore, the physician decided to remove the benchmark and the distal end broke into two pieces in the physician's hands outside of the patient without exercising force.The procedure was then completed using a new benchmark and the same neuron max.There was no report of an adverse effect to the patient.
Additional Manufacturer Narrative
Results: the benchmark was ovalized in multiple locations from the hub.The benchmark was fractured approximately 107.5 cm from the hub.Conclusions: evaluation of the returned benchmark confirmed that the catheter shaft was fractured and revealed ovalizations on the distal fractured segment.If the device is forcefully gripped or otherwise mishandled during use, damage such as ovalizations may occur.If the device is ovalized, resistance may be experienced during retraction.If the device is forcefully retracted against resistance, damage such as a fracture may occur.Further evaluation of the returned benchmark revealed additional ovalizations along the length of the catheter shaft.These damages were likely incidental to the reported complaint and may have occurred while packaging the device for return to penumbra.The neuron max identified in the complaint was not returned for evaluation.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.
Additional Manufacturer Narrative
Please note that the following section was incorrectly reported on the follow-up #01 mfr report and is being corrected on this follow-up #02 mfr report:3005168196-2019-01462.Results: the benchmark was ovalized in multiple locations on its proximal shaft.The benchmark was fractured approximately 107.5 cm from the hub.The benchmark was ovalized at the distal tip.Conclusions: evaluation of the returned benchmark confirmed a fracture on the distal shaft.The proximal side of the fracture site shows stretching while the distal side of the fracture site shows necking.Although it was reported to have completely fractured outside of the patient, the damage was observed under fluoroscopy.This indicates the device likely became pinned and was subsequently retracted against resistance.If the device is retracted against resistance, it may become damaged in a way that could lead to fracture.The device may have become pinned due to difficulty anatomy or interaction with other devices used during the procedure.The neuron max was not returned for evaluation and the root cause of the device becoming pinned could not be determined.Further evaluation revealed proximal ovalizations.Based on their location, these ovalizations were likely incidental and may have occurred post-procedure or during packaging for return.Further evaluation also revealed an ovalization on the distal fractured portion of the benchmark.This was also likely incidental and occurred due to handling post-procedure.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: 8833296
• Report Number: 3005168196-2019-01462
• Device Sequence Number: 2070817
• Product Code: DQY
• UDI-Device Identifier: 00814548014043
• UDI-Public: 00814548014043
• Combination Product (Y/N): Y
• Initial Reporter Country: CO
• PMA/510(K) Number: K142321
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: distributor,foreign,health pr
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 06/28/2019
• 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: 11/19/2021
• Device Catalogue Number: BMK6F105M
• Device Lot Number: F87100
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/05/2019
• Was the Report Sent to FDA?: Yes
• Date Report to Manufacturer: 01/10/2005
• Initial Date Received by Manufacturer: 06/28/2019
• Supplement Date Received by Manufacturer: 08/16/2019; 01/14/2005
• Initial Report FDA Received Date: 07/26/2019
• Supplement Report FDA Received Date: 08/29/2019; 10/24/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 70 YR
• Date Report Sent to FDA: 01/01/2005