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

Catalog Number	BMK6F105M
Medical Device Problem Codes	Device Damaged Prior to Use (2284); Material Deformation (2976)
Health Effect - Clinical Code	No Patient Involvement (2645)
Date of Event	04/09/2018
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 coil embolization procedure, the physician noticed that the tip of a benchmark delivery catheter (benchmark) had become ovalized while attempting to advance into the introducer sheath.The damage to the benchmark occurred prior to use, and, therefore, the benchmark was not used in the procedure.The procedure was completed using a new benchmark.
Additional Manufacturer Narrative
Results: the benchmark was ovalized approximately, 101.0 through 110.0 cm from the hub.The benchmark was kinked approximately 4.5, 15.0, 61.0 cm from the hub.Conclusions: evaluation of the returned benchmark revealed that the catheter was ovalized and kinked.If the peel-able sheath provided by penumbra is not used to protect the distal tip of catheter during advancement into another device, damage such as ovalization may occur.Further evaluation of the returned benchmark revealed that the catheter was kinked.These kinks were likely incidental and may have occurred during packaging of the device for return to penumbra.Penumbra catheters are visually 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: 7485146
• Report Number: 3005168196-2018-00945
• Device Sequence Number: 144375
• Product Code: DQY
• UDI-Device Identifier: 00814548014043
• UDI-Public: 00814548014043
• Combination Product (Y/N): Y
• Initial Reporter Country: UK
• 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: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 04/09/2018
• 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: Physician
• Device Expiration Date: 11/30/2020
• Device Catalogue Number: BMK6F105M
• Device Lot Number: F80819
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/07/2018
• Was the Report Sent to FDA?: Yes
• Date Report to Manufacturer: 01/10/2005
• Initial Date Received by Manufacturer: 04/09/2018
• Supplement Date Received by Manufacturer: 08/01/2018
• Initial Report FDA Received Date: 05/03/2018
• Supplement Report FDA Received Date: 08/01/2018
• 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