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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 Problem Material Rupture (1546)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 02/27/2024
Event Type  malfunction  
Manufacturer Narrative
E1 - initial reporter facility name:(b)(6) hospital.
 
Event Description
It was reported that a balloon rupture occurred.The 99% stenosed target lesion was located in the moderately tortuous and severely calcified proximal left anterior descending artery.A 10mmx3.00mm wolverine coronary cutting balloon was selected for use in a tight lesion.During the procedure, it was noted that the balloon ruptured upon inflation at 6atm for 1 second and the contrast agent has leaked due to balloon rupture.The device was removed using normal method without issue and the procedure was completed with a different device.No complications were reported and patient was good post procedure.
 
Event Description
It was reported that a balloon rupture occurred.The 99% stenosed target lesion was located in the moderately tortuous and severely calcified proximal left anterior descending artery.A 10mmx3.00mm wolverine coronary cutting balloon was selected for use in a tight lesion.During the procedure, it was noted that the balloon ruptured upon inflation at 6atm for 1 second and the contrast agent has leaked due to balloon rupture.The device was removed using normal method without issue and the procedure was completed with a different device.No complications were reported and patient was good post procedure.
 
Manufacturer Narrative
E1 - initial reporter facility name: (b)(6) hospital.Device evaluated by mfr.: the device was returned for analysis.A visual examination of the balloon identified no damages.No issues identified with the hypotube shaft.Shaft polymer extrusion: no kinks or damages.A detailed microscopic examination of the balloon material identified no tears or pinholes in the balloon.All blades were fully bonded on the balloon and did not exhibit any signs of damage.No issues identified during examination of the extrusion shaft.Tip showed no signs of tip damage.Using an encore inflation unit (tested before and after use with druck pressure gauge, the balloon was inflated to its rated burst pressure (rbp) of 12 atmospheres (atm).The balloon inflated fully and maintained pressure for 15sec, with no leaks noted.A vacuum was applied and the balloon deflated fully with no resistance.The balloon was inflated to its rbp on three more occasions with no leaks noted.No issues were identified with balloon inflation or the balloon material.
 
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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 Key18913979
MDR Text Key337781332
Report Number2124215-2024-15869
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
Reporter Occupation Physician
Type of Report Initial,Followup
Report Date 04/16/2024
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received03/15/2024
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 Number0032303337
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer03/11/2024
Is the Reporter a Health Professional? Yes
Date Manufacturer Received03/27/2024
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured08/28/2023
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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