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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION WOLVERINE CORONARY CUTTING BALLOON MONORAIL; CATHETER, PERCUTANEOUS TRANSLUMINAL CORONARY ANGIOPLASTY (PTCA), CUTTING/SCORING
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BOSTON SCIENTIFIC CORPORATION WOLVERINE CORONARY CUTTING BALLOON MONORAIL; CATHETER, PERCUTANEOUS TRANSLUMINAL CORONARY ANGIOPLASTY (PTCA), CUTTING/SCORING Back to Search Results
Model Number 3851
Device Problem Material Rupture (1546)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 12/02/2019
Event Type  malfunction  
Manufacturer Narrative
(b)(6).
 
Event Description
It was reported that the balloon ruptured.The 90% stenosed target lesion was located in the severely tortuous and severely calcified left circumflex artery.A 10mmx3.00mm wolverine coronary cutting balloon monorail was selected for use.During procedure, the was inflated at 6atm and 12atm respectively.However, the balloon ruptured upon second inflation and was able to be removed without problem.The procedure was completed with another of the same device.No patient complications were reported.
 
Event Description
It was reported that the balloon ruptured.The 90% stenosed target lesion was located in the severely tortuous and severely calcified left circumflex artery.A 10mmx3.00mm wolverine coronary cutting balloon monorail was selected for use.During procedure, the was inflated at 6atm and 12atm respectively.However, the balloon ruptured upon second inflation and was able to be removed without problem.The procedure was completed with another of the same device.No patient complications were reported.It was further reported that the device was simply pulled out from the patient's body and the patient condition was good post procedure.
 
Manufacturer Narrative
Initial reporter city:(b)(6).Age at time of event: under 18 years.
 
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Brand Name
WOLVERINE CORONARY CUTTING BALLOON MONORAIL
Type of Device
CATHETER, PERCUTANEOUS TRANSLUMINAL CORONARY ANGIOPLASTY (PTCA), CUTTING/SCORING
Manufacturer (Section D)
BOSTON SCIENTIFIC CORPORATION
two scimed place
maple grove MN 55311
MDR Report Key9435075
MDR Text Key175700676
Report Number2134265-2019-15232
Device Sequence Number1
Product Code NWX
Combination Product (y/n)N
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,distri
Type of Report Initial,Followup
Report Date 12/11/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/08/2019
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model Number3851
Device Catalogue Number3851
Device Lot Number0024288125
Was Device Available for Evaluation? No
Date Manufacturer Received12/02/2019
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Treatment
BALLOON CATHETER: NEICHI SAPPHIRE 3/2.0M; BALLOON CATHETER: NEICHI SAPPHIRE 3/2.0M; GUIDEWIRE: ASAHI INTEC SION BLUE; GUIDEWIRE: ASAHI INTEC SION BLUE; INFLATION DEVICE: BSJ ENCORE; INFLATION DEVICE: BSJ ENCORE; INTRODUCER SHEATH: TERUMO 6FR SHEATH; INTRODUCER SHEATH: TERUMO 6FR SHEATH; MICRO CATHETER: TERUMO ALTAVIEW; MICRO CATHETER: TERUMO ALTAVIEW
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