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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 04/01/2024
Event Type  malfunction  
Event Description
It was reported that a balloon rupture occurred.The 50% stenosed target lesion was located in the moderately tortuous and mildly calcified proximal of left anterior descending artery (lad).A 15mmx3.50mm wolverine coronary cutting balloon was selected for use.During the procedure, a 3.0 mm non boston scientific stent was placed in the middle part of the lad.Inflation was then performed three times at 8 atm, 20 atm, and 20 atm with the tip inserted from the proximal part to the middle part of the target lesion.When an attempt was made to perform the fourth inflation, the balloon did not inflate, and when the device was checked outside the body, it was found that the balloon ruptured.The physician's comment was it was caught in the strut of the stent at the distal part.The procedure was completed with this device.No patient complications reported.
 
Manufacturer Narrative
Device evaluated by mfr.: the device was returned for analysis.Multiple kinks were identified along the hypotube shaft.A visual and tactile examination identified no damages in the shaft polymer extrusion.A visual examination identified that a few blades lifted and detached.A detailed microscopic examination of the balloon material identified no issues.The balloon was returned in a deflated state.No issues identified during examination of the extrusion shaft.Blades: a microscopic examination of the blade segments identified the following: blade 1: one section of the proximal blade segment (approximately 4mm) was missing.The pad was fully bonded onto the balloon.Blade 2: about 2mm of a blade segment was not returned, the proximal part of the blade was bonded onto the pad and balloon.Blade 3: one segment of the blade and pad was lifted.Blade 4: a blade was lifted from the balloon in the proximal section.A microscopic examination of the tip section found no damage.The device was attached to an encore inflation unit and the balloon was inflated to its rated burst pressure of 12 atmospheres with no leaks or damages.Encore device verified before and after use using the druck gauge.No other device issues were identified during returned product analysis.
 
Event Description
It was reported that a balloon rupture occurred.The 50% stenosed target lesion was located in the moderately tortuous and mildly calcified proximal of left anterior descending artery (lad).A 15mmx3.50mm wolverine coronary cutting balloon was selected for use.During the procedure, a 3.0 mm non boston scientific stent was placed in the middle part of the lad.Inflation was then performed three times at 8 atm, 20 atm, and 20 atm with the tip inserted from the proximal part to the middle part of the target lesion.When an attempt was made to perform the fourth inflation, the balloon did not inflate, and when the device was checked outside the body, it was found that the balloon ruptured.The physician's comment was it was caught in the strut of the stent at the distal part.The procedure was completed with this device.No patient complications 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 Key19153242
MDR Text Key341272825
Report Number2124215-2024-24209
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
Report Date 04/22/2024
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received04/22/2024
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 Number0031416528
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer04/15/2024
Is the Reporter a Health Professional? Yes
Date Manufacturer Received04/01/2024
Was Device Evaluated by Manufacturer? No
Date Device Manufactured04/13/2023
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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