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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: TRIREME MEDICAL INC. CHOCOLATE PTA BALLOON CATHETER

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TRIREME MEDICAL INC. CHOCOLATE PTA BALLOON CATHETER Back to Search Results
Catalog Number CB14-135-40120CW
Device Problems Break (1069); Detachment Of Device Component (1104)
Patient Problem Foreign Body In Patient (2687)
Event Date 06/20/2018
Event Type  Injury  
Event Description
Chocolate pta balloon catheter was inserted into patient's sfa to balloon. After balloon was deflated it got hung up on the stent and the balloon broke off the shaft as it was being removed over the wire. The balloon was successfully retrieved and removed intact.
 
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Brand NameCHOCOLATE PTA BALLOON CATHETER
Type of DeviceBALLOON CATHETER
Manufacturer (Section D)
TRIREME MEDICAL INC.
pleasanton CA 94566
MDR Report Key7637702
MDR Text Key112487265
Report NumberMW5078034
Device Sequence Number1
Product Code LIT
Combination Product (y/n)N
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 Received06/25/2018
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue NumberCB14-135-40120CW
Device Lot NumberF170922500
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?
Type of Device Usage

Patient Treatment Data
Date Received: 06/25/2018 Patient Sequence Number: 1
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