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

Model Number BMK6F95MBER120

Device Problems Collapse (1099); Device Damaged Prior to Use (2284); Material Deformation (2976)

Patient Problem No Patient Involvement (2645)

Event Date 04/09/2019

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 thrombectomy procedure using a benchmark delivery microcatheter (benchmark), the physician found that the tip of the benchmark was kinked and flattened.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 delivery microcatheter (benchmark) was kinked approximately 6.0, 42.0, 77.5 and 79.5 cm from the hub.The device was ovalized from approximately 95.0 ¿ 96.5 cm from the hub.The device was fractured approximately 96.5 cm from the hub.Conclusions: evaluation of the returned benchmark confirmed a distal ovalization and revealed a fractured distal tip.If the packaging mandrel becomes unsecured from the packaging card, it may pin the benchmark between the packaging tube and packaging mandrel during retraction from the packaging.If the benchmark is subsequently retracted while its distal tip is pinned, the distal tip will likely become damaged.Further evaluation revealed kinks throughout the device.These damages were 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.

Manufacturer Narrative

Please note that the following section was incorrectly reported on the follow-up #01 mfr report and is being corrected on this follow-up #02 mfr report: 3005168196-2019-00937.1.Section h.Box 10/11.Narrative/corrected data results: the benchmark was kinked approximately 6.0, 42.0, 77.5 and 79.5 cm from the hub.The device was ovalized from approximately 95.0 ¿ 96.5 cm from the hub.The device was fractured approximately 96.5 cm from the hub.Conclusions: evaluation of the returned benchmark confirmed the ovalization and revealed the tip was fractured.The tip of the device is packaged with a mandrel within the tip of the device that would prevent this damage prior to removal from its packaging.If the tip of the device becomes pinched or gripped inadvertently during of after removal from the packaging, the tip will likely become ovalized.If the tip is further manipulated it may eventually fracture.Further evaluation revealed kinks throughout the device.These damages were 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: 8601592
• MDR Text Key: 144794530
• Report Number: 3005168196-2019-00937
• Device Sequence Number: 1
• Product Code: DQY
• UDI-Device Identifier: 00814548014173
• UDI-Public: 00814548014173
• Combination Product (y/n): Y
• PMA/PMN Number: K142321
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,foreign,health pr
• Type of Report: Initial,Followup,Followup
• Report Date: 01/01/2005,04/12/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/10/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 01/29/2022
• Device Model Number: BMK6F95MBER120
• Device Catalogue Number: BMK6F95MBER120
• Device Lot Number: F88238
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/20/2019
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 01/01/2005
• Date Report to Manufacturer: 01/10/2005
• Date Manufacturer Received: 05/29/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1