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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: EV3 INC. RAPIDCROSS PTA RAPID EXCHANGE BALLOON DILATATION CATHETER CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL

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EV3 INC. RAPIDCROSS PTA RAPID EXCHANGE BALLOON DILATATION CATHETER CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL Back to Search Results
Model Number A14BX020060170
Device Problem Detachment of Device or Device Component (2907)
Patient Problem Foreign Body In Patient (2687)
Event Date 12/07/2021
Event Type  malfunction  
Event Description
While performing an intervention on an arterial lower extremity chronic total occlusion, an angioplasty balloon was inflated within the lesion. At some point thereafter, the physician was attempting to remove the balloon and it became detached from the shaft (catheter) within the artery. Device remains in patient. Fda safety report id# (b)(4).
 
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Brand NameRAPIDCROSS PTA RAPID EXCHANGE BALLOON DILATATION CATHETER
Type of DeviceCATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL
Manufacturer (Section D)
EV3 INC.
plymouth MN 55442
MDR Report Key13001998
MDR Text Key282325106
Report NumberMW5106011
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 Risk Manager
Type of Report Initial
Report Date 12/09/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/13/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberA14BX020060170
Device Lot NumberB214038
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? No
Is This a Reprocessed and Reused Single-Use Device? No

Patient Treatment Data
Date Received: 12/13/2021 Patient Sequence Number: 1
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