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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: TRIREME MEDICAL, INC. CHOCOLATE PTA BALLOON CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL

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TRIREME MEDICAL, INC. CHOCOLATE PTA BALLOON CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL Back to Search Results
Lot Number F140725007
Device Problems Wire (430); Difficult to Remove (1528); Component Missing (2306)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 04/28/2015
Event Type  Injury  
Event Description

During a pta of a right leg a chocolate balloon was inflated. After inflation the balloon was removed and upon inspection, the nitinol wire that is usually on the balloon was not present. Upon further angiography of the right leg the nitinol wire was located in the stent and we could not retrieve it.

 
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Brand NameCHOCOLATE PTA BALLOON
Type of DeviceCATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL
Manufacturer (Section D)
TRIREME MEDICAL, INC.
7060 koll center parkway suite
pleasanton CA 94566
MDR Report Key4846832
MDR Text Key5937243
Report Number4846832
Device Sequence Number1
Product Code LIT
Combination Product (Y/N)
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source User Facility
Type of Report Initial
Report Date 06/10/2015
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received06/10/2015
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? Yes
Device Operator
Device LOT NumberF140725007
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? No Answer Provided
Was the Report Sent to FDA? Yes
Date Report Sent to FDA06/10/2015
Event Location Hospital
Date Report TO Manufacturer06/16/2015

Patient TREATMENT DATA
Date Received: 06/10/2015 Patient Sequence Number: 1
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