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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 3852
Device Problems Material Rupture (1546); Adverse Event Without Identified Device or Use Problem (2993)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 10/25/2023
Event Type  malfunction  
Event Description
It was reported that balloon rupture occurred.The 90% stenosed target lesion was located in the moderately tortuous and moderately calcified left anterior descending artery.A 15mmx2.50mm wolverine coronary cutting balloon was selected for use.During the procedure, the balloon ruptured upon first inflation at 12 atmospheres for 15 seconds.The device was removed without any problem and the procedure was completed with another of the same device.No complications were reported.
 
Manufacturer Narrative
Device evaluated by mfr.: the device was returned for analysis.A visual examination of the balloon identified no damages.A hypotube kink was identified 69.5cm distal to the distal end of the strain relief.Along the polymer extrusion there were multiple kinks.Microscopic examination of the balloon material identified no tears or pinholes in the balloon.However, when inflating the balloon, the inflation liquid was coming from the mid-section of the balloon.A detailed microscopic examination on the mid-section identified a tear 4mm distal from the proximal makerband.All blades were fully bonded on the balloon and did not exhibit any signs of damage.Multiple kinks were identified along the polymer extrusion.Tip showed no signs of tip damage.A microscopic examination of the proximal and distal markerbands identified no damage.The device was inflated to 12 atm as per instructions for use.Using the inflation aid, a leak was noted in the mid-section of the balloon.Microscopic examination identified a tear 4mm distal from proximal markerband.The encore inflation device was verified before and after the procedure using a druck gauge.
 
Event Description
It was reported that balloon rupture occurred.The 90% stenosed target lesion was located in the moderately tortuous and moderately calcified left anterior descending artery.A 15mmx2.50mm wolverine coronary cutting balloon was selected for use.During the procedure, the balloon ruptured upon first inflation at 12 atmospheres for 15 seconds.The device was removed without any problem and the procedure was completed with another of the same device.No complications were reported.
 
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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
300 boston scientific way
marlborough MA 01752
Manufacturer (Section G)
BOSTON SCIENTIFIC CORPORATION
ballybrit business park
galway
EI  
Manufacturer Contact
rachel shields
4100 hamline ave n
arden hills, MN 55112
6512422111
MDR Report Key18097810
MDR Text Key327717678
Report Number2124215-2023-62993
Device Sequence Number1
Product Code NWX
Combination Product (y/n)N
Reporter Country CodeJA
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Other,Foreign,Health Professional,Company Representative,Distributor
Reporter Occupation Physician
Type of Report Initial,Followup
Report Date 11/27/2023
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 Number3852
Device Catalogue Number3852
Device Lot Number0031649149
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer11/03/2023
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 10/25/2023
Initial Date FDA Received11/08/2023
Supplement Dates Manufacturer Received11/17/2023
Supplement Dates FDA Received11/27/2023
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured05/19/2023
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
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