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

Model Number BMK6F95BER120

Device Problems Break (1069); Unraveled Material (1664); Physical Resistance/Sticking (4012)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 06/28/2020

Event Type  Injury  

Manufacturer Narrative

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

Event Description

The patient was undergoing a coil embolization procedure in the posterior communication artery (pcom) using a benchmark 6f 071 delivery catheter (benchmark) and a non-penumbra 6f radial sheath.During the procedure, the physician inserted the benchmark through the sheath and into the patient using the right radial access.While advancing up the benchmark towards the target vessel, the physician experienced resistance and decided to remove the benchmark.Upon removal of the benchmark from the sheath, the physician noticed that the tip of the benchmark had broken off.It was reported that the braiding of the benchmark unraveled within the axillary and right subclavian arteries, and that 10 centimeters of the tip of the benchmark was in the radial artery.Subsequently, an angiogram revealed patent subclavian, axillary, brachial and ulnar arteries, but a fully occluded radial artery.The physician then made a second puncture in the groin and completed the coiling.Afterwards, the broken benchmark tip was removed using a snare device.The final fragment of the benchmark was removed via surgery in the right axillary region.The procedure ended at this point.There was no report of an adverse effect to the patient.

Manufacturer Narrative

Results: the returned benchmark was stretched approximately 46.0 cm, 47.0 cm, 48.0 cm and 52.0 cm from the hub.The device was fractured approximately 53.0 cm, 59.0 cm, 77.0 cm and 92.0 cm from the hub.The total length of the returned benchmark was 92.0 cm.Conclusions: evaluation of the returned benchmark confirmed a fracture and revealed stretching near the site of the fracture.If the device is forcefully retracted against resistance, the catheter may begin to stretch.If the device continues to be retracted against resistance it may subsequently fracture as a result.Further evaluation of the device revealed additional fractures on the distal portion of the fractured catheter.This damage was likely incidental to the complaint and may have occurred during attempts to remove the device from the patient.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.H3 other text : placeholder.

• 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: 10380178
• MDR Text Key: 202059053
• Report Number: 3005168196-2020-01138
• 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: foreign,user facility
• Type of Report: Initial,Followup
• Report Date: 01/01/2005,07/15/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/07/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 06/02/2022
• Device Model Number: BMK6F95BER120
• Device Catalogue Number: BMK6F95BER120
• Device Lot Number: F90707
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/09/2020
• 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: 09/28/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 50 YR