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

Model Number	BMK6F105M
Medical Device Problem Codes	Fracture (1260); Leak/Splash (1354)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/18/2021
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 stent-assisted coiling procedure in the anterior communicating artery (acom) using a benchmark 6f 071 delivery catheter (benchmark) and a non-penumbra short introducer sheath.It was noted that patient anatomy was tortuous.During the procedure, the physician advanced a benchmark through a short introducer sheath into the cervical artery.Afterwards, an angiogram was performed and subsequently, the physician noticed that the image was not clear and indicated possible leakage somewhere on the benchmark.Therefore, the physician decided to remove the benchmark and the short introducer sheath together.Upon removal, it was noticed that the mid-shaft of the benchmark was broken but intact.It was also reported that the physician was unable to remove the benchmark from the short introducer sheath.The procedure was completed by placing a stent in the vessel without any intermediate catheter and a new introducer sheath.There was no report of an adverse effect to the patient.
Additional Manufacturer Narrative
Evaluation of the returned benchmark confirmed that the device was fractured and was unable to be removed from a non-penumbra short sheath.If the benchmark is forcefully retracted against resistance, damage such as a fracture may occur.Evaluation of the non-penumbra sheath revealed ovalizations.The root cause of this damage could not be determined; however, this damage may contribute to the resistance during retraction.Further evaluation of the benchmark revealed a kink and ovalizations along the device.This damage may be 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.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: 11770627
• Report Number: 3005168196-2021-00941
• Device Sequence Number: 17088437
• Product Code: DQY
• UDI-Device Identifier: 00814548014043
• UDI-Public: 00814548014043
• Combination Product (Y/N): Y
• Initial Reporter Country: KS
• 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
• Report Date (Section B): 04/07/2021
• 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?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 08/05/2023
• Device Model Number: BMK6F105M
• Device Catalogue Number: BMK6F105M
• Device Lot Number: F99325
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/12/2021
• Was the Report Sent to FDA?: Yes
• Date Report to Manufacturer: 01/10/2005
• Initial Date Received by Manufacturer: 04/07/2021
• Supplement Date Received by Manufacturer: 05/04/2021
• Initial Report FDA Received Date: 05/04/2021
• Supplement Report FDA Received Date: 05/18/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 48 YR
• Date Report Sent to FDA: 01/01/2005