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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION SMALL PERIPHERAL CUTTING BALLOON; CATHETERS, TRANSLUMINAL CORONARY ANGIOPLASTY, PERCUTANEOUS
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BOSTON SCIENTIFIC CORPORATION SMALL PERIPHERAL CUTTING BALLOON; CATHETERS, TRANSLUMINAL CORONARY ANGIOPLASTY, PERCUTANEOUS Back to Search Results
Model Number 24658
Device Problems Difficult to Remove (1528); Material Rupture (1546)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 11/08/2019
Event Type  malfunction  
Event Description
It was reported that balloon rupture occurred.A 4.00mm/1.5cm/140cm small peripheral cutting balloon was selected for use.During preparation, the balloon cover was very hard to be removed.The balloon cover eventually was able to be removed and the device use continued.During inflation the balloon ruptured at 6 atm upon first inflation.The device was simply pulled out from the patient's body.The procedure was completed with another of same device.No complications were reported and patient condition was good post procedure.
 
Manufacturer Narrative
Device evaluated by manufacturer: the device was returned for analysis.Two balloon protectors were received with the returned device.The both of the returned balloon protector's inner dimensions were verified at 0.0435 inch using a pin gauge.This is within the specified range of 0.0420 inches to 0.0435 inches 'balloon protector 3.5mm thru 4mm'.A visual examination identified that the balloon was not folded which indicates that the balloon was subjected to positive pressure.Blood was identified within the balloon and inflation lumen which is evidence of a device leak.The returned device was attached to a boston scientific encore inflation unit.Positive pressure was applied when liquid was observed to be leaking from a balloon pinhole located approximately 2mm distal to the distal end of the proximal markerband.An examination of the balloon material and proximal markerband identified no issues which could potentially have contributed to this complaint.The rated burst pressure for this device is 12 atmospheres as per spcb flextome specification.A visual and tactile examination identified with the hypotube or shaft of the device.
 
Event Description
It was reported that balloon rupture occurred.A 4.00mm/1.5cm/140cm small peripheral cutting balloon was selected for use.During preparation, the balloon cover was very hard to be removed.The balloon cover eventually was able to be removed and the device use continued.During inflation the balloon ruptured at 6 atm upon first inflation.The device was simply pulled out from the patient's body.The procedure was completed with another of same device.No complications were reported and patient condition was good post procedure.
 
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Brand Name
SMALL PERIPHERAL CUTTING BALLOON
Type of Device
CATHETERS, TRANSLUMINAL CORONARY ANGIOPLASTY, PERCUTANEOUS
Manufacturer (Section D)
BOSTON SCIENTIFIC CORPORATION
two scimed place
maple grove MN 55311
MDR Report Key9366072
MDR Text Key168703113
Report Number2134265-2019-14370
Device Sequence Number1
Product Code NWX
Combination Product (y/n)N
PMA/PMN Number
P950020
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Type of Report Initial,Followup
Report Date 12/17/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model Number24658
Device Catalogue Number24658
Device Lot Number0023631164
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer11/19/2019
Initial Date Manufacturer Received 11/08/2019
Initial Date FDA Received11/22/2019
Supplement Dates Manufacturer Received12/11/2019
Supplement Dates FDA Received12/17/2019
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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