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

Model Number	BMK6F95BER120
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	Vascular Dissection (3160)
Date of Event	10/14/2021
Type of Reportable Event	Serious Injury
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 coil embolization procedure in the right middle cerebral artery (mca) using a benchmark 6f 071 delivery catheter (benchmark), a px slim delivery microcatheter (px slim) and penumbra smart coils (smart coils).During the procedure, the physician successfully implanted the smart coils in the target vessel using the px slim and benchmark.Subsequently, while removing the benchmark, a piece of the benchmark broke off in the vessel.Therefore, the physician decided to use a snare device to retrieve the broken piece.While removing the broken piece of the benchmark using the snare device, the femoral artery became damaged.Subsequently, the patient underwent a vascular repair of the groin puncture site.The procedure ended after the successful vascular repair.
Event or Problem Description
The patient was undergoing a coil embolization procedure in the right middle cerebral artery (mca) using a non-penumbra short sheath, a benchmark 6f 071 delivery catheter (benchmark), a non-penumbra microcatheter and penumbra smart coils (smart coils).During the procedure, the physician successfully implanted the smart coils in the target vessel using the microcatheter and benchmark.Subsequently, while removing the benchmark, a piece of the benchmark broke off in the vessel.Therefore, the physician decided to use a snare device to retrieve the broken piece.While removing the broken piece of the benchmark using the snare device, the femoral artery became damaged.Subsequently, the patient underwent a vascular repair of the groin puncture site.The procedure ended after the successful vascular repair.
Additional Manufacturer Narrative
Please note that the following section is being updated based on additional information received from the device return: 1.Section b.Box 5.Describe event or problem.Evaluation of the returned benchmark confirmed the device was fractured on its proximal shaft.This damage typically occurs if the device is forcefully retracted against resistance.Evaluation of the non-penumbra short sheath revealed a tear along the length of the device starting on the distal end.The cause of this damage could not be determined.This damage may have contributed to resistance during retraction of the benchmark and may have contributed to the benchmark becoming fractured.Evaluation also revealed damage near the fracture and unraveled internal coil winds.This damage likely occurred during snaring attempts to retrieve the benchmark.Further evaluation revealed additional kinks along the device.This damage was likely incidental to the reported complaint.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.
Additional Manufacturer Narrative
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• Brand Name: BENCHMARK 6F 071 DELIVERY CATHETER
• Common Device Name: DQY
• Manufacturer (Section D): PENUMBRA, INC.; one penumbra place; alameda CA 94502
• Manufacturer Contact: veronica farris ; one penumbra place; alameda, CA 94502 ; 5107483200
• MDR Report Key: 12785162
• Report Number: 3005168196-2021-02521
• Device Sequence Number: 17142004
• Product Code: DQY
• UDI-Device Identifier: 00814548014128
• UDI-Public: 00814548014128
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: K142321
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 08/22/2022
• 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?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 07/25/2024
• Device Model Number: BMK6F95BER120
• Device Catalogue Number: BMK6F95BER120
• Device Lot Number: F107915
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/29/2021
• Is the Reporter a Health Professional?: Yes
• 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: 10/14/2021
• Supplement Date Received by Manufacturer: 12/30/2021; 01/14/2005
• Initial Report FDA Received Date: 11/10/2021
• Supplement Report FDA Received Date: 12/31/2021; 08/22/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/26/2021
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 70 YR
• Patient Sex: Male
• Date Report Sent to FDA: 01/01/2005