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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 Difficult to Remove (1528); Stretched (1601); Difficult to Advance (2920)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 10/16/2020
Event Type  malfunction  
Manufacturer Narrative
(b)(4).
 
Event Description
It was reported that the balloon was difficult to remove.A 10mmx2.25mm wolverine coronary cutting balloon was selected for use.During procedure, the balloon was advanced along the guidewire, but it was not smooth enough to advance.Consequently, the physician then tried to retract the balloon; however, resistance was met and it could not be pulled out.When the device was slightly pulled out, the shaft was felt to be stretched.The device was replaced with another of the same device and it was able to be used without any problem.There were no complications reported.
 
Manufacturer Narrative
E1: initial reporter facility name: (b)(6).E1: initial reporter city: (b)(6).Device evaluated by the manufacturer.The device was returned for analysis.The shaft polymer extrusion of this device was found to be stretched to such a degree that the proximal marker band was visible within the distal balloon cone.Balloon folds were found to be tightly wrapped at the proximal end of the balloon, however the folds were forced open on the distal end of the balloon due to the stretching that had occurred to the polymer extrusion inside the balloon.No issues were noted with the blades or pads of this device.All blades were secure in their pads and all pads were fully secured to the balloon material.No issues were noted with the tip section of the device.A visual and microscopic examination found no issue with the marker bands.A visual and tactile examination was completed on the hypotube of the device and no issues were noted.
 
Event Description
It was reported that the balloon was difficult to remove.A 10mmx2.25mm wolverine coronary cutting balloon was selected for use.During procedure, the balloon was advanced along the guidewire, but it was not smooth enough to advance.Consequently, the physician then tried to retract the balloon; however, resistance was met and it could not be pulled out.When the device was slightly pulled out, the shaft was felt to be stretched.The device was replaced with another of the same device and it was able to be used without any problem.There were no complications reported.The device was returned for analysis and investigation was completed on 27nov2020.The shaft polymer extrusion of this device was found to be stretched to such a degree that the proximal marker band was visible within the distal balloon cone.Balloon folds were found to be tightly wrapped at the proximal end of the balloon, however the folds were forced open on the distal end of the balloon due to the stretching that had occurred to the polymer extrusion inside the balloon.No issues were noted with the blades or pads of this device.All blades were secure in their pads and all pads were fully secured to the balloon material.No issues were noted with the tip section of the device.A visual and microscopic examination found no issue with the marker bands.A visual and tactile examination was completed on the hypotube of the device and no issues were noted.
 
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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 Key10791244
MDR Text Key214752411
Report Number2134265-2020-14795
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 12/09/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received11/05/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Expiration Date07/10/2022
Device Model Number3851
Device Catalogue Number3851
Device Lot Number0025699213
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer10/29/2020
Date Manufacturer Received11/27/2020
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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