MAUDE Adverse Event Report: CAREFUSION, INC COSGROVE FLEX QCK-BEND 61MM FOGARTY-TYPE; CLAMP, VASCULAR

Catalog Number CV1161

Device Problems Break (1069); Material Separation (1562)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 08/20/2020

Event Type  malfunction  

Manufacturer Narrative

(b)(4).A device is anticipated for investigation.Once the investigation has been completed a supplemental emdr will be submitted for the investigation results.If any additional information is received a supplemental will be submitted with those details.

Event Description

It was reported that the instrument was broken, fell apart, and had broken wires.No patient injury reported.

Manufacturer Narrative

(b)(6) supplemental emdr.Investigation results: the f16 sample was examined.This sample was returned as separated broken pieces.Essentially, the broken pieces of the whole sample were the handle/body end, the broken off cable wire attached to the clamp jaws end with all 32 beads still remaining on the cable, held in by the frayed broken ends of the cable wire.Etchings on the sample were faded yet still noted to be legible.The sample¿s age is evidenced by the usage marks, discoloration, and surface scratches/scuffing.These marks were noted particularly towards the working end of the sample and the handle holding end.It was evident that the f16 sample failed at the cable wire.The breakage occurred right at the point where the cable wire begins at the handle end.No fraying of the cable wires at the cable/clamp jaws end were noted.It appeared as all 19 wires in the cable broke right at that one point, possibly indicating sudden excessive forces may have been applied.The cable wire strands were counted at individual strands to confirm 19 wires.Sample was completely non-functional, but it could also be repaired by replacing the swaged cable fitting assembly.Upon closer visual inspections of the f16 sample, the severed ends did display discoloration and oxidation.Additionally, the ends were noted to display signs of a possible ductile breakage, this occurs by applying an extremely heavy force upon the handles to close the ratchet.It has likely seen 4 years of usage, and failure could have also been caused by repeated twisting and crimping forces, which occur during activation and clamping action as usage fatigue.These combined potential factors may have contributed to reported the failure mode.No other breakpoints, corrosion, damages, or signs of excessive forces were observed on the cable wire assembly.The rest of the sample was observed to be normal, with no additional issues, the cable wire can be removed and replaced.The most probable root cause for the f16 was determined to be mechanical overstress.Possible wire breakage from usage, fatigue, frictional forces, twisting and/or pulling forces over time may have caused and/or accelerated the rate of the failure.It should be noted that the sample have been in use, any additional factors such as improper care, lack of inspection/maintenance and/or lack of lubrication could have also contributed to the failure mode.H3 other text : evaluation has been performed.

Event Description

It was reported that the instrument was broken, fell apart, and had broken wires.No patient injury reported.

• Brand Name: COSGROVE FLEX QCK-BEND 61MM FOGARTY-TYPE
• Type of Device: CLAMP, VASCULAR
• Manufacturer (Section D): CAREFUSION, INC; 75 n. fairview drive; vernon hills IL 60061
• MDR Report Key: 10541383
• MDR Text Key: 207183227
• Report Number: 1423507-2020-00036
• Device Sequence Number: 1
• Product Code: DXC
• Combination Product (y/n): N
• PMA/PMN Number: K991589
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,other
• Type of Report: Initial,Followup
• Report Date: 10/30/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/16/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: CV1161
• Device Lot Number: F16
• Date Manufacturer Received: 08/27/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other