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

Catalog Number	BMK6F95
Medical Device Problem Code	Material Puncture/Hole (1504)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	07/18/2019
Type of Reportable Event	Malfunction
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 middle cerebral artery (mca) using a benchmark 6f 071 delivery catheter (benchmark).During the procedure, the physician advanced the benchmark to the target vessel using a guidewire and a select catheter for access.Approximately one hour into the procedure using the benchmark and a non-penumbra microcatheter, the physician noticed a hole near the hub of the benchmark and it was leaking with saline; therefore, the benchmark was removed.The procedure was completed using another benchmark and the same microcatheter.There was no report of an adverse effect to the patient.
Additional Manufacturer Narrative
Results: the benchmark was kinked approximately 2.5 and 9.5 cm from the hub.The strain relief was unraveled approximately 2.5 cm and a hole was present in the catheter shaft.The benchmark was ovalized approximately 93.0, 96.0, and 99.0 cm from the hub.During functional testing, a syringe was used to flush air through the benchmark and bubbles were observed coming from the kinked/hole underneath the strain relief.Conclusions: evaluation of the returned benchmark revealed that the catheter was kinked and leaking at the strain relief.If the benchmark is forcefully manipulated at extreme angles during use, damage such as a kink may occur.If the kinked device is further manipulated, damage such as a hole may occur.Further evaluation of the returned benchmark revealed that the catheter was ovalized.This damage was likely incidental to the reported complaint.Penumbra catheters are visually inspected during in-process 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.

• 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: 8897606
• Report Number: 3005168196-2019-01590
• Device Sequence Number: 1617882
• Product Code: DQY
• UDI-Device Identifier: 00814548014111
• UDI-Public: 00814548014111
• Combination Product (Y/N): Y
• Initial Reporter State: NY
• Initial Reporter Country: US
• PMA/510(K) Number: K142321
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 07/18/2019
• 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: 12/06/2021
• Device Catalogue Number: BMK6F95
• Device Lot Number: F87380
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/24/2019
• Was the Report Sent to FDA?: Yes
• Date Report to Manufacturer: 01/10/2005
• Initial Date Received by Manufacturer: 07/18/2019
• Supplement Date Received by Manufacturer: 10/10/2019
• Initial Report FDA Received Date: 08/15/2019
• Supplement Report FDA Received Date: 11/01/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 51 YR
• Date Report Sent to FDA: 01/01/2005