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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 Problem Material Rupture (1546)
Patient Problems No Consequences Or Impact To Patient (2199); No Clinical Signs, Symptoms or Conditions (4582)
Event Date 12/22/2020
Event Type  malfunction  
Event Description
It was reported that a balloon rupture occurred.The 75% stenosed target lesion was located in the moderately tortuous and mildly calcified superficial femoral artery.A 3.50mm/1.5cm/140cm small peripheral cutting balloon was selected for use.During procedure, at first inflation, it was noted that the balloon ruptured at nominal pressure.The device was removed from the patient's body and the procedure was completed with another of same device.No patient complications were reported and there was no problem with patient's condition post procedure.
 
Event Description
It was reported that a balloon rupture occurred.The 75% stenosed target lesion was located in the moderately tortuous and mildly calcified superficial femoral artery.A 3.50mm/1.5cm/140cm small peripheral cutting balloon was selected for use.During procedure, at first inflation, it was noted that the balloon ruptured at nominal pressure.The device was removed from the patient's body and the procedure was completed with another of same device.No patient complications were reported and there was no problem with patient's condition post procedure.
 
Manufacturer Narrative
Device evaluated by mfr: the device was returned for evaluation.A visual examination identified that the balloon was not folded which indicates that the device was subjected to positive pressure.Blood was identified within the balloon which is evidence of a device leak.The returned device was attached to an encore inflation unit.Positive pressure was applied when liquid was observed to be leaking from a balloon pinhole located approximately 5mm proximal of the distal markerband.An examination of the balloon material and markerbands identified no issues which could potentially have contributed to this complaint.A visual and microscopic examination observed no damage to the tip or blades.All blades were present and fully bonded to the balloon surface.No kinks or damage were noted along the hypotube or shaft of the device.No other issues were identified during the product analysis.
 
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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 Key11067541
MDR Text Key223600402
Report Number2134265-2020-18425
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 02/03/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/23/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Expiration Date06/27/2022
Device Model Number24658
Device Catalogue Number24658
Device Lot Number0024030250
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer01/18/2021
Date Manufacturer Received01/28/2021
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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