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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: COOK INCORPORATED COOK MEDICAL; FLEXOR CHECK-FLO INTRODUCER
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COOK INCORPORATED COOK MEDICAL; FLEXOR CHECK-FLO INTRODUCER Back to Search Results
Model Number G11638
Device Problems Break (1069); Detachment Of Device Component (1104); Physical Resistance (2578)
Patient Problem Foreign Body In Patient (2687)
Event Date 01/05/2018
Event Type  Injury  
Event Description
Endoscopic vascular case where the pt was under moderate sedation for angiogram procedure.When case was being finished the surgeon tried to remove the sheath and felt resistance.Attempts were made to free the device but removal was unsuccessful and a piece of it snapped off - remaining in the pt.Pt placed under general anesthesia and incisions were made to remove the sheath.Visual inspection does seem as if the device was defective.They are 3 layers; the introducer, then the coil and an outer sheath.In one large area, the coil and sheath remained together but had some completely off of the introducer.In another smaller area, the sheath and bits of the coil had come off.Ref mfr # 1820334-2018-00195.
 
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Brand Name
COOK MEDICAL
Type of Device
FLEXOR CHECK-FLO INTRODUCER
Manufacturer (Section D)
COOK INCORPORATED
750 daniels way
bloomington IN 47404
MDR Report Key7227687
MDR Text Key98668443
Report NumberMW5074935
Device Sequence Number1
Product Code DYB
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Voluntary
Reporter Occupation Risk Manager
Type of Report Initial
Report Date 01/09/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received01/26/2018
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Expiration Date07/28/2020
Device Model NumberG11638
Device Lot Number8101516
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? Yes
Was Device Evaluated by Manufacturer? No Information
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage N
Patient Sequence Number1
Patient Outcome(s) Required Intervention;
Patient Age55 YR
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