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

Catalog Number BMK6F95BER120

Device Problems Device Damaged Prior to Use (2284); Material Deformation (2976)

Patient Problem No Patient Involvement (2645)

Event Date 12/03/2018

Event Type  malfunction  

Manufacturer Narrative

This device is available for return.A follow up mdr will be submitted upon completion of the device investigation.

Event Description

During preparation for a medical procedure, the physician found that the benchmark 6f 071 delivery catheter (benchmark) was kinked at the hub, upon removal from the packaging loop.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.

Manufacturer Narrative

Results: the benchmark was kinked approximately 5.0 cm and 47.0 cm from the hub.Bends were present approximately 15.0 cm, 21.0 cm and 38.0 cm from the hub.The device was ovalized approximately 95.0 cm and 96.0 ¿ 100.0cm from the hub.Conclusions: evaluation of the returned benchmark confirmed the device was kinked.If the device is removed from the packaging tube at extreme angles, damages such as kinks are likely to occur.Further evaluation revealed ovalizations and bends along the device.These bends and ovalizations are likely incidental to the reported complaint 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
• Type of Device: DQY
• Manufacturer (Section D): PENUMBRA, INC.; one penumbra place; alameda CA 94502
• MDR Report Key: 8206837
• MDR Text Key: 131774161
• Report Number: 3005168196-2018-02548
• Device Sequence Number: 1
• Product Code: DQY
• UDI-Device Identifier: 00814548014128
• UDI-Public: 00814548014128
• Combination Product (y/n): Y
• PMA/PMN Number: K142321
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup
• Report Date: 01/01/2005,12/03/2018

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
• Device Operator: Health Professional
• Device Expiration Date: 08/30/2021
• Device Catalogue Number: BMK6F95BER120
• Device Lot Number: F85626
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/18/2019
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 01/01/2005
• Date Report to Manufacturer: 01/10/2005
• Initial Date Manufacturer Received: 12/03/2018
• Initial Date FDA Received: 12/31/2018
• Supplement Dates Manufacturer Received: 02/13/2019
• Supplement Dates FDA Received: 02/25/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1