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

Catalog Number BMK6F95M

Device Problems Bent (1059); Device Damaged Prior to Use (2284); Out-Of-Box Failure (2311)

Patient Problem No Patient Involvement (2645)

Event Date 02/10/2017

Event Type  malfunction  

Manufacturer Narrative

Results: the benchmark 6f 071 delivery catheter (benchmark dc) was kinked approximately 6.0 cm from the hub.The distal tip of the benchmark dc was ovalized approximately 99.5 cm from the distal tip.Conclusions: evaluation of the returned device revealed that the benchmark dc was kinked and ovalized.These types of damages likely occurred due to forceful handling of the device during removal from the packaging.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.

Event Description

During preparation for a medical procedure, the radiologist noticed that the tip of the benchmark 6f 071 delivery catheter (benchmark dc) was bent upon removal from the packaging.It was reported that the outer packaging of the device did not appear to be damaged.The bent benchmark dc was noticed prior to use and therefore, was not used in the procedure.The procedure was completed using a new benchmark dc.

• Brand Name: BENCHMARK 6F 071 DELIVERY CATHETER
• Type of Device: DQY
• Manufacturer (Section D): PENUMBRA, INC.; one penumbra place; alameda CA 94502
• Manufacturer Contact: veronica farris ; one penumbra place; alameda, CA 94502 ; 5107483200
• MDR Report Key: 6397613
• MDR Text Key: 69751125
• Report Number: 3005168196-2017-00347
• Device Sequence Number: 1
• Product Code: DQY
• UDI-Device Identifier: 00814548014166
• UDI-Public: 00814548014166
• Combination Product (y/n): N
• Reporter Country Code: UK
• PMA/PMN Number: K142321
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 02/10/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/10/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Radiologic Technologist
• Device Expiration Date: 10/26/2019
• Device Catalogue Number: BMK6F95M
• Device Lot Number: F72500
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/07/2017
• Date Manufacturer Received: 02/10/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/26/2016
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1