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

Catalog Number	BMK6F115M
Medical Device Problem Codes	Device Damaged Prior to Use (2284); Material Deformation (2976)
Health Effect - Clinical Code	No Patient Involvement (2645)
Date of Event	02/01/2019
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
During preparation for a medical procedure, the pharmacist noticed that the distal tip of a benchmark 6f 071 delivery catheter (benchmark) was flattened upon opening of the packaging.The damage to the benchmark was found prior to use and, therefore, it was not used in the procedure.The procedure was completed using another benchmark.
Additional Manufacturer Narrative
Results: the returned product display was damaged.The device was ovalized at approximately 25.0 cm from the hub.The distal tip was undamaged.Conclusions: evaluation of the returned benchmark revealed damage to the product display box and an ovalization on the proximal shaft of the device.These damages were likely a result of improper handling during transit.No damage was found on the distal portion of the device; therefore, the reported distal tip flattening could not be confirmed.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: 8404445
• Report Number: 3005168196-2019-00433
• Device Sequence Number: 1922702
• Product Code: DQY
• UDI-Device Identifier: 00814548014104
• UDI-Public: 00814548014104
• Combination Product (Y/N): Y
• 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: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 02/07/2019
• 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: 02/13/2021
• Device Catalogue Number: BMK6F115M
• Device Lot Number: F81869
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/11/2019
• Was the Report Sent to FDA?: Yes
• Date Report to Manufacturer: 01/10/2005
• Initial Date Received by Manufacturer: 02/07/2019
• Supplement Date Received by Manufacturer: 04/03/2019
• Initial Report FDA Received Date: 03/08/2019
• Supplement Report FDA Received Date: 05/03/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Date Report Sent to FDA: 01/01/2005