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

Catalog Number	BMK6F115M
Medical Device Problem Codes	Leak/Splash (1354); Device Damaged Prior to Use (2284)
Health Effect - Clinical Code	No Patient Involvement (2645)
Date of Event	11/15/2017
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
While preparing a benchmark 6f 071 delivery catheter (benchmark) for thrombectomy procedure, the physician flushed the benchmark and noticed a leak at the base of the proximal end.Therefore, the benchmark was set aside and the procedure was completed using another benchmark.
Additional Manufacturer Narrative
Results: the benchmark was fractured under the strain relief, approximately 2.0 cm from the hub.The benchmark was kinked in multiple locations throughout its length.Conclusions: evaluation of the returned device revealed it was fractured near the hub.This damage may have occurred due to forceful handling of the benchmark at extreme angles during removal from the packaging or preparation for use.The fracture allowed fluid to leak out of the catheter shaft during flushing.Further evaluation revealed the benchmark was kinked in multiple locations throughout its length.This damage was likely incidental and may 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.

• 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: 7164167
• Report Number: 3005168196-2018-00026
• Device Sequence Number: 1340558
• Product Code: DQY
• UDI-Device Identifier: 00814548014104
• UDI-Public: 00814548014104
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• 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: Health Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 12/07/2017

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: Physician
• Device Expiration Date: 05/18/2020
• Device Catalogue Number: BMK6F115M
• Device Lot Number: F77237
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/19/2018
• Initial Date Received by Manufacturer: 12/07/2017
• Supplement Date Received by Manufacturer: 02/14/2018
• Initial Report FDA Received Date: 01/04/2018
• Supplement Report FDA Received Date: 02/27/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1