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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: COOK INC FUSION TITAN DILATION BALLOON; FGE CATHETER, BILIARY, DIAGNOSTIC

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COOK INC FUSION TITAN DILATION BALLOON; FGE CATHETER, BILIARY, DIAGNOSTIC Back to Search Results
Model Number G49219
Device Problems Hole In Material (1293); Inflation Problem (1310)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 03/17/2015
Event Type  malfunction  
Manufacturer Narrative
This mdr is being filed after the associated complaint was reviewed under remediation protocol (b)(4), complaint/mdr retrospective review and remediation and reassessed as reportable.Additional complaint investigation and record remediation was not performed.
 
Event Description
It was reported that when the user tried to dilate the stricture, the balloon would not inflate.They then removed the balloon and attempted to inflate it outside the patient, and they found that there was a hole in the balloon.There were no injuries or additional procedures, and no pieces of the device remained in the patient.
 
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Brand Name
FUSION TITAN DILATION BALLOON
Type of Device
FGE CATHETER, BILIARY, DIAGNOSTIC
Manufacturer (Section D)
COOK INC
750 daniels way
bloomington IN 47404
Manufacturer Contact
larry pool
750 daniels way
bloomington, IN 47404
8128294891
MDR Report Key7273539
MDR Text Key100471774
Report Number1820334-2018-00498
Device Sequence Number1
Product Code FGE
UDI-Device Identifier00827002492196
UDI-Public(01)00827002492196(17)170113(10)5573492
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,health
Reporter Occupation Other Health Care Professional
Type of Report Initial
Report Date 02/15/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received02/15/2018
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model NumberG49219
Device Catalogue NumberFS-BDB-4X4
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? Yes
Date Manufacturer Received02/14/2018
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured01/13/2015
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
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