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U.S. Department of Health and Human Services

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

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CAREFUSION, INC COSGROVE FLEX QCK-BEND 61MM FOGARTY-TYPE CLAMP, VASCULAR Back to Search Results
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.
 
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Brand NameCOSGROVE FLEX QCK-BEND 61MM FOGARTY-TYPE
Type of DeviceCLAMP, 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 Key10766560
MDR Text Key240977983
Report Number1423507-2020-00053
Device Sequence Number1
Product Code DXC
Combination Product (y/n)N
Reporter Country CodeCA
PMA/PMN Number
K991589
Number of Events Reported1
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 Received10/30/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue NumberCV1161
Device Lot NumberH01
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer09/30/2020
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received08/27/2020
Was Device Evaluated by Manufacturer? No
Is the Device Single Use? No Answer Provided
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Reuse

Patient Treatment Data
Date Received: 10/30/2020 Patient Sequence Number: 1
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