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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 Detachment of Device or Device Component (2907); Difficult to Advance (2920)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 08/30/2021
Event Type  malfunction  
Event Description
It was reported that part of the balloon broke off.The 50% stenosed target lesion was located in the mildly tortuous and mildly calcified cephalic vein.A 3.00mm/1.5cm/140cm small peripheral cutting balloon was selected for use.During the procedure, after the device was prepped and hydrated, a wire was placed.However, the device could not track over the wire any further.When the physician pushed the balloon, it was noted that some part of the device came apart.The device was removed by pulling the device and the wire.The procedure was completed with another of same device.No patient complications were reported.
 
Manufacturer Narrative
Device evaluated by manufacturer: the device was returned for analysis.A visual examination identified that the balloon was not folded which indicates that the device was subjected to positive pressure.The rated burst pressure for this device is 12 atmospheres (as per spcb flextome specification.A microscopic examination identified a balloon longitudinal tear beginning approximately 4mm proximal of the proximal balloon sleeve and extending approximately 13mm distally from the proximal balloon sleeve.From the longitudinal tear a partial circumferential tear was identified.Part of the balloon material was detached and not returned with the device.A non-bsc guidewire was returned with the device.A visual and tactile examination identified multiple kinks along the length of the guidewire.The guidewire od (outer diameter) was measured and the results were within specification.A visual and microscopic examination observed no damage to the tip or blades.All blades were present and fully bonded to the balloon surface.A visual and tactile examination identified that the shaft had detached 1115 mm distally from the distal end of the strain relief.This type of damage is consistent with excessive force being applied when attempting to advance the device.The midshaft was damaged and kinked.The inner shaft was stretched and accordioned and pulled in a distal direction.The two markerbands were firmly attached to the inner but had moved in a distal direction along with the inner shaft due to the stretched inner.No other issues were noted with the markerbands.
 
Event Description
It was reported that part of the balloon broke off.The 50% stenosed target lesion was located in the mildly tortuous and mildly calcified cephalic vein.A 3.00mm/1.5cm/140cm small peripheral cutting balloon was selected for use.During the procedure, after the device was prepped and hydrated, a wire was placed.However, the device could not track over the wire any further.When the physician pushed the balloon, it was noted that some part of the device came apart.The device was removed by pulling the device and the wire.The procedure was completed with another of same device.No patient complications were reported.
 
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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 Key12497370
MDR Text Key272218730
Report Number2134265-2021-11463
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,foreig
Type of Report Initial,Followup
Report Date 10/19/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received09/20/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Expiration Date11/05/2023
Device Model Number24658
Device Catalogue Number24658
Device Lot Number0026310952
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer09/15/2021
Date Manufacturer Received10/06/2021
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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