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

Model Number	BMK6F95MBER120
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	05/18/2020
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 basilar artery using a benchmark 6f 071 delivery catheter (benchmark).During the procedure, the physician used the benchmark, a balloon catheter and two microcatheters to implant the coils in the target vessel.While performing the final angiography through the benchmark at the end of the procedure, the physician noticed that the benchmark was broken at the mid-shaft.It was reported that after several attempts, the physician was able to remove the broken piece of the benchmark using a bigger femoral sheath and a snare device.The procedure ended at this point.There was no report of an adverse effect to the patient.
Event or Problem Description
The patient was undergoing a coil embolization procedure in the basilar artery using a benchmark 6f 071 delivery catheter (benchmark).During the procedure, the physician used the benchmark, a balloon catheter and one microcatheter to implant the coils in the target vessel.While performing the final angiography through the benchmark at the end of the procedure, the physician noticed that the benchmark was broken at the mid-shaft.It was reported that after several attempts, the physician was able to remove the broken piece of the benchmark using a bigger femoral sheath and a snare device.The procedure ended at this point.There was no report of an adverse effect to the patient.
Additional Manufacturer Narrative
Please note that the following section was incorrectly reported on the initial mfr report and is being corrected on this follow-up #01 mfr report:(b)(4).1.Section b.Box 5.Describe event or problem results: the benchmark was fractured approximately 33.0 cm from the hub.The device was kinked approximately 8.0 cm and 44.0 cm from the hub.The total length of the benchmark was approximately 95.0 cm.The distal shaft was undamaged.Conclusions: evaluation of the returned benchmark confirmed a mid-shaft fracture.There was no stretching on either end of the fracture and the material was folding backwards at the fracture.This indicates that the fracture was likely a result of a kink.If the device is manipulated at extreme angles during use, the catheter may become kinked.Subsequently retracting the kinked catheter may result in the device fracture.Further evaluation of the device revealed kinks.These kinks were likely incidental to the complaint and could 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.H3 other text : placeholder.

• 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: 10170212
• Report Number: 3005168196-2020-00781
• Device Sequence Number: 16682412
• Product Code: DQY
• UDI-Device Identifier: 00814548014173
• UDI-Public: 00814548014173
• Combination Product (Y/N): Y
• Initial Reporter Country: UK
• 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): 05/19/2020
• 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?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 02/18/2023
• Device Model Number: BMK6F95MBER120
• Device Catalogue Number: BMK6F95MBER120
• Device Lot Number: F96319
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/22/2020
• Was the Report Sent to FDA?: Yes
• Date Report to Manufacturer: 01/10/2005
• Initial Date Received by Manufacturer: 05/19/2020
• Supplement Date Received by Manufacturer: 07/17/2020
• Initial Report FDA Received Date: 06/18/2020
• Supplement Report FDA Received Date: 07/30/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Date Report Sent to FDA: 01/01/2005