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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: COOK, INC. BALLOON DILATOR

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COOK, INC. BALLOON DILATOR Back to Search Results
Model Number ADVANCE14LP
Device Problems Break (1069); Detachment Of Device Component (1104)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 06/20/2018
Event Type  Injury  
Event Description
After balloon inflation the catheter was being removed from the pt, and the balloon catheter broke off inside the sheath. Sheath was removed along with the broken off piece intact and the entire broken off piece was removed from the pt.
 
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Brand NameBALLOON DILATOR
Type of DeviceBALLOON DILATOR
Manufacturer (Section D)
COOK, INC.
MDR Report Key7633737
MDR Text Key112306985
Report NumberMW5078023
Device Sequence Number1
Product Code LIT
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Voluntary
Reporter Occupation Other Health Care Professional
Type of Report Initial
Report Date 06/21/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received06/22/2018
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date08/03/2018
Device Model NumberADVANCE14LP
Device Lot Number8652236
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer06/21/2018
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Was Device Evaluated by Manufacturer?
Is the Device Single Use?
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage

Patient Treatment Data
Date Received: 06/22/2018 Patient Sequence Number: 1
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