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

Model Number	BMK6F105BER130
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/27/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Evaluation of the returned benchmark revealed catheter was fractured, and the complaint was confirmed.Evaluation revealed that the distal fractured segment was not returned for evaluation.Based on the returned condition and the reported event, the root cause of this damage could not be determined.Penumbra products are visually inspection 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.
Event or Problem Description
The patient was undergoing a medical procedure using a benchmark 6f 071 delivery catheter (benchmark).During the procedure, it was reported that the distal end of the benchmark broke off into the patient¿s artery.It is unknown how the procedure was completed.
Event or Problem Description
The patient was undergoing a medical procedure using a benchmark 6f 071 delivery catheter (benchmark) and a diagnostic catheter in the right subclavian artery.During the procedure, the diagnostic catheter and the benchmark were advanced together in the target location with the diagnostic catheter inside the benchmark.It was reported that the physician experienced resistance advancing the catheters in the mid-upper arm.Then, the diagnostic catheter was removed, and selective angiography was performed using the benchmark.The angiography revealed inadvertent selection of a small artery arising from the branch of a right brachial artery.Verapamil was then used to aid removal of the benchmark and to alleviate any vasospasm.After administration of verapamil, the physician attempted to withdraw the benchmark; however, the distal end of the benchmark broke leaving the retained fragment in the right arm.The benchmark appeared to be fractured and unraveled, leaving a small inner coil fragment from the catheter tethered from the upper arm to the arterial access site at the right wrist.It is unknown how the procedure was completed.
Additional Manufacturer Narrative
Please note that this complaint was submitted to the fda by the user facility with the following reference number: 1001510000-2021-8025 the following sections are being updated based on additional information included in the user facility report submitted to the fda: 1.Section b.Box 5.Describe event or product problem.2.Section e.Box 4.Initial reporter also sent report to fda.2.Section g.Box 3.Report source.3.Section h.Box 6.Results code 1, results code 2, results code 3 & results code 4.4.Section h.Box 6.Conclusions code 1.5.Section h.Box 10/11.Narrative/corrected data.Evaluation of the returned benchmark confirmed that the catheter was fractured.Based on the ovalization and lack of stretching at the fracture site, it is likely that the device became fractured after it was kinked.The inadvertent selection of a small artery as indicated in the reported complaint may have contributed to resistance during the procedure.If the device is forcefully retracted against resistance, damage such as kink and a subsequent fracture of the device upon retraction.The distal fractured segment was not returned for evaluation.Penumbra products are visually inspection 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
• Manufacturer Contact: veronica farris ; one penumbra place; alameda, CA 94502 ; 5107483200
• MDR Report Key: 12872326
• Report Number: 3005168196-2021-02686
• Device Sequence Number: 6025128
• Product Code: DQY
• UDI-Device Identifier: 00814548014029
• UDI-Public: 00814548014029
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K142321
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 12/17/2021
• 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: 05/13/2024
• Device Model Number: BMK6F105BER130
• Device Catalogue Number: BMK6F105BER130
• Device Lot Number: F106264
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/08/2021
• 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: 10/28/2021
• Supplement Date Received by Manufacturer: 12/01/2021
• Initial Report FDA Received Date: 11/24/2021
• Supplement Report FDA Received Date: 12/17/2021
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/14/2021
• 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: Other
• Patient Age: 50 YR
• Patient Sex: Female
• Date Report Sent to FDA: 01/01/2005