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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); Failure to Advance (2524)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 06/11/2023
Event Type  malfunction  
Event Description
It was reported that a balloon rupture occurred.The 50% stenosed target lesion was located in the mildly tortuous and mildly calcified proximal left circumflex artery.A 15mmx2.25mm wolverine coronary cutting balloon was selected for use.During the procedure, the device was difficult to cross lesion at the bend.When the head was in and half of the balloon was over the lesion, it was noted that a rupture occurred when the ballooning pressure was increased to 4 atm.Physician's comment was it was tight because of the blades at the bent.The procedure was completed with a different device.No patient complications were reported.
 
Event Description
It was reported that a balloon rupture occurred.The 50% stenosed target lesion was located in the mildly tortuous and mildly calcified proximal left circumflex artery.A 15mmx2.25mm wolverine coronary cutting balloon was selected for use.During the procedure, the device was difficult to cross lesion at the bend.When the head was in and half of the balloon was over the lesion, it was noted that a rupture occurred when the ballooning pressure was increased to 4 atm.Physician's comment was it was tight because of the blades at the bent.The procedure was completed with a different device.No patient complications were reported.It was further reported that there was no issue noted with the blade of the balloon.The device was removed using normal method without issue.
 
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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 IRELAND LIMITED
ballybrit business park
galway
EI  
Manufacturer Contact
rachel shields
4100 hamline ave n
arden hills, MN 55112
6512422111
MDR Report Key17288211
MDR Text Key318677568
Report Number2124215-2023-32037
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 Foreign,Health Professional,Company Representative,Distributor
Reporter Occupation Physician
Type of Report Initial,Followup
Report Date 07/17/2023
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 Expiration Date06/17/2023
Device Model Number3852
Device Catalogue Number3852
Device Lot Number0027509179
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 06/15/2023
Initial Date FDA Received07/10/2023
Supplement Dates Manufacturer Received07/12/2023
Supplement Dates FDA Received07/17/2023
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured06/17/2021
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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