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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 Problems Material Rupture (1546); Failure to Advance (2524)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 11/05/2019
Event Type  malfunction  
Manufacturer Narrative
(b)(6).
 
Event Description
It was reported that a balloon rupture occurred.The severely stenosed target lesion was located in a moderately tortuous and severely calcified right coronary artery 1 and 2.A 10mmx3.50mm wolverine coronary cutting balloon was selected for use.During procedure, at first inflation, it was noted that the device had difficulty crossing and was unable to add pressure.Subsequently, the balloon ruptured.The device was simply removed from the patient's body.The procedure was completed with a different device.No patient complications were reported and the patient was good post procedure.
 
Event Description
It was reported that a balloon rupture occurred.The severely stenosed target lesion was located in a moderately tortuous and severely calcified right coronary artery 1 and 2.A 10mmx3.50mm wolverine coronary cutting balloon was selected for use.During procedure, at first inflation, it was noted that the device had difficulty crossing and was unable to add pressure.Subsequently, the balloon ruptured.The device was simply removed from the patient's body.The procedure was completed with a different device.No patient complications were reported and the patient was good post procedure.
 
Manufacturer Narrative
Initial reporter city: (b)(6).Device evaluated by mfr: the device was returned for evaluation.A visual examination identified that the balloon was not folded which indicates that the balloon was inflated.Blood was identified within the balloon and inflation lumen which is evidence of a device leak.The returned device was attached to an encore inflation unit and positive pressure was applied in an attempt to inflate the balloon.The balloon could not be inflated due to the presence of solidified blood that was present within the inflation lumen.The device was soaked in a water bath at a temperature of 37 degrees celsius to help soften the blood before further inflation attempts were made.The device was removed from the bath and the balloon was again attached to an inflation device subjected to positive pressure and liquid was observed to be leaking from damage located between 11mm and 16mm from the guidewire exit port.The balloon could not be inflated due to a leak in the shaft of the device.A visual and microscopic examination could find no issue with the balloon or blades that could have potentially contributed to the complaint incident.All blades were present and fully bonded to the surface of the balloon.A visual and microscopic examination found no issue with the profile of the device's markerbands which could have contributed to the complaint incident.A visual and tactile examination of the device identified no kinks on the polymer extrusion shaft of the device.Traces of blood were identified within the shaft and balloon which is evidence of a device leak.The returned device was attached to an encore inflation unit.Positive pressure was applied, and liquid was observed to be leaking from a damage site located between 11mm and 16mm from the guidewire exit port.A microscopic examination of the polymer extrusion shaft identified abrasions around the site of the damaged areas of the polymer extrusion shaft.These abrasions and damage are an indication that the shaft of the device had an interaction with another object.A visual and tactile examination of the hypotube was completed.No damage or any issues were noted with the hypotube that could have contributed to the complaint incident.The tip section of the device was visually and microscopically examined, there was minor damage noted to the distal point of the tip.No other damage or any other issues were noted with the tip that could have contributed to the complaint incident.No other issues were identified during the product analysis.
 
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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 Key9351129
MDR Text Key168715423
Report Number2134265-2019-14220
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 12/09/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received11/20/2019
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 Number0024000459
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer11/19/2019
Date Manufacturer Received12/05/2019
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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