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

Model Number	BMK6F105M
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	Air Embolism (1697)
Date of Event	05/03/2022
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 medical procedure in the internal carotid artery (ica) using a benchmark 6f 071 delivery catheter (benchmark), a non-penumbra short sheath and a non-penumbra flow diverting stent.During the procedure, the physician placed the flow diverting stent using the benchmark and short sheath.Subsequently, it was noticed that the strain relief of the benchmark was leaking, and an air embolism was noted.Therefore, the benchmark was removed.The physician then treated the air embolism by partially aspirating using a non-penumbra catheter and the remainder by a dose of 100% oxygen.The procedure ended at this point.The patient was discharged on (b)(6) 2022 symptom free.
Additional Manufacturer Narrative
Evaluation of the returned benchmark confirmed the catheter was leaking due to a fracture underneath the strain relief.If the device is manipulated against resistance or at extreme angles during use, damage such as a kink and subsequent fracture may occur.Further evaluation revealed kinks on the proximal shaft and stretching on the distal shaft.This damage was incidental to the reported complaint and the root cause could not be determined.Air embolism is included as a possible complication with the benchmark intracranial access system.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
• Manufacturer Contact: veronica farris ; one penumbra place; alameda, CA 94502 ; 5107483200
• MDR Report Key: 14569843
• Report Number: 3005168196-2022-00248
• Device Sequence Number: 6177671
• Product Code: DQY
• UDI-Device Identifier: 00814548014043
• UDI-Public: 00814548014043
• Combination Product (Y/N): N
• Initial Reporter Country: SZ
• 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
• Report Date (Section B): 08/02/2022
• 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: 05/13/2024
• Device Model Number: BMK6F105M
• Device Catalogue Number: BMK6F105M
• Device Lot Number: F106268
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• 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: 05/06/2022
• Supplement Date Received by Manufacturer: 07/11/2022
• Initial Report FDA Received Date: 06/01/2022
• Supplement Report FDA Received Date: 08/02/2022
• 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: 55 YR
• Patient Sex: Female
• Date Report Sent to FDA: 01/01/2005