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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 100% stenosed target lesion was located in the moderately tortuous and severely calcified vessel below the knee.A 2.00mmx1.5cmx140cm small peripheral cutting balloon was selected for use.During the procedure, it was noted that the balloon ruptured upon first inflation at 6 atmospheres for 10 seconds.The balloon was removed from the patient's body without any problem using the normal method and the procedure was completed with another of the same device.No complications were reported and the patient was in good condition after the procedure.
 
Manufacturer Narrative
Device evaluated by mfr: the device was returned for analysis.A visual and tactile examination identified two complete breaks of the hypotube.The first break is located approximately 520mm distal of the strain relief.The second break is located distal edge of the manifold.The hypotube was also noted to be kinked at more than one location along its length.This type of damage is consistent with excessive force being applied to the delivery system.No other issues were noted with the hypotube that may have contributed to the complaint incident.A visual examination identified that the balloon was not folded which indicates that the balloon was subjected to positive pressure.The condition of the returned device would not allow the investigator to inflate the balloon in the normal fashion, due to the break in the hypotube.As a result, an inflation aid (epidural fixture) was attached to the distal section of the hypotube break.This facilitated the connection of a boston scientific encore inflation unit which allowed the balloon to be inflated.The returned device was attached to an encore inflation unit and positive pressure was applied, the balloon was inflated to its rate of burst pressure of 12 atmospheres for 30 seconds using digital timer without issue.A vacuum was then applied, and the balloon was fully deflated without issue.The inflation device was verified at 12 atmospheres, before and after use with a calibrated pressure gauge.This inflation and deflation to rated burst pressure of 12 atmospheres was repeated three times with no leaks or drop in pressure noted.No issues were identified with balloon inflation, balloon deflation or the balloon material.A visual and microscopic examination identified no damage to the markerbands or blades of the device.All blades were present and fully bonded to the balloon material.A microscopic examination identified no damage to the tip of the device.No other issues were identified during the product analysis.
 
Event Description
It was reported that a balloon rupture occurred.The 100% stenosed target lesion was located in the moderately tortuous and severely calcified vessel below the knee.A 2.00mmx1.5cmx140cm small peripheral cutting balloon was selected for use.During the procedure, it was noted that the balloon ruptured upon first inflation at 6 atmospheres for 10 seconds.The balloon was removed from the patient's body without any problem using the normal method and the procedure was completed with another of the same device.No complications were reported and the patient was in good condition after the 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 Key11077040
MDR Text Key223773439
Report Number2134265-2020-18502
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,distri
Type of Report Initial,Followup
Report Date 02/16/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/28/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Expiration Date11/28/2022
Device Model Number24658
Device Catalogue Number24658
Device Lot Number0024848966
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer01/18/2021
Date Manufacturer Received02/01/2021
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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