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

Catalog Number	BMK6F105M
Medical Device Problem Codes	Break (1069); Failure to Advance (2524); Physical Resistance/Sticking (4012)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	01/23/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device has been returned and the investigation results are pending.A follow up mdr will be submitted upon completion of the device investigation.
Event or Problem Description
The patient was undergoing a medical procedure in the basilar artery using a benchmark 6f 071 delivery catheter (benchmark).During the procedure, the physician experienced resistance and was unable to advance the benchmark in the non-penumbra short sheath and, consequently the proximal end of the benchmark broke.The benchmark was, therefore, removed, and the procedure was completed using a neuron max 6f 088 long sheath (neuron max) with the same sheath.There was no report of an adverse effect to the patient.
Additional Manufacturer Narrative
Results: the benchmark was fractured approximately 5.0 and 104.0 cm from the hub.The benchmark was kinked approximately 4.5, 31.0, 38.0 and 99.0 cm from the hub.Conclusions: evaluation of the returned benchmark revealed that the catheter shaft was fractured on the proximal end.If the device is forcefully advanced against resistance, damage such as a fracture on the proximal end of the catheter may occur.Further evaluation revealed a fracture on the distal end of the catheter in addition to kinks and bends along the length of the device.Based on the reported complaint, these damages were likely incidental to the complaint and likely occurred 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: 8362750
• Report Number: 3005168196-2019-00331
• Device Sequence Number: 2017819
• Product Code: DQY
• UDI-Device Identifier: 00814548014043
• UDI-Public: 00814548014043
• Combination Product (Y/N): Y
• Initial Reporter Country: IT
• 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): 01/23/2019
• 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: 06/27/2021
• Device Catalogue Number: BMK6F105M
• Device Lot Number: F84364
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/11/2019
• Was the Report Sent to FDA?: Yes
• Date Report to Manufacturer: 01/10/2005
• Initial Date Received by Manufacturer: 01/23/2019
• Supplement Date Received by Manufacturer: 04/05/2019
• Initial Report FDA Received Date: 02/22/2019
• Supplement Report FDA Received Date: 05/03/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 52 YR
• Date Report Sent to FDA: 01/01/2005