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) initial emdr submission.Investigation results: the h01 sample was examined.The sample was noted to be on whole piece as normal yet 4-5 of the cable wire strands were noted to be broken/severed at the distal and proximal end.The clamping action was loose and not to specification.The strands were noted to have severed close to the end points, which is where the strands experience most of the mechanical stress.Upon closer visual inspections, the severed ends displayed light discoloration or oxidation, the ends were noted to display signs of a combination of shearing and ductile breakage, possibly by either applying an extremely heavy force upon the handles to close the ratchet.Sample is about 19 years old; 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 the failure mode.No other breakpoints, corrosion, damages or signs of excessive forces were observed on the cable wire assembly.The sample was considered at risk for completely snapping and breaking at the cable wires if used further.Sample was completely non-functional.The most probable root cause for the h01 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.Evaluation has been performed.

Event Description

Additional sample was received upon sample return.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; 5 sunnen drive; st. louis MO 63143
• Manufacturer (Section G): CAREFUSION, INC; 5 sunnen drive; st. louis MO 63143
• Manufacturer Contact: anna wehrheim ; 75 n. fairview drive; vernon hills, IL 60061 ; 8015652341
• MDR Report Key: 10766560
• MDR Text Key: 240977983
• Report Number: 1423507-2020-00053
• Device Sequence Number: 1
• Product Code: DXC
• Combination Product (y/n): N
• Reporter Country Code: CA
• PMA/PMN Number: K991589
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,other
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 10/30/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/30/2020
• 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: H01
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/30/2020
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/27/2020
• Was Device Evaluated by Manufacturer?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Patient Outcome(s): Other