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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 3851
Device Problem Material Rupture (1546)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 11/09/2021
Event Type  malfunction  
Event Description
It was reported that the balloon ruptured.The target lesion was located in the moderately tortuous and moderately calcified artery.A 10mmx2.50mm wolverine coronary cutting balloon was selected for use.During the procedure, it was noted that the balloon ruptured upon inflation at 5 atmospheres for about 20 seconds.The procedure was completed with a different device.There was no patient injury.
 
Manufacturer Narrative
The wolverine cb mr, ous 10mmx2.50mm was returned for analysis.A visual examination identified that the balloon with the balloon folds intact.The returned device was attached to an encore inflation unit and positive pressure was applied in an attempt to inflate the balloon.Liquid was observed to be leaking from a balloon pinhole located at 3mm proximal to the distal markerband.An examination of the balloon material and markerbands identified no issues which could potentially have contributed to this complaint.All blades were intact within their pads and fully bonded to the balloon material.A visual and tactile examination identified no issues.A visual and tactile examination identified no issues.The markerbands and tip and of the device were visually and microscopically examined, and no issues were noted with the device that may have potentially contributed to the complaint incident.
 
Event Description
It was reported that the balloon ruptured.The target lesion was located in the moderately tortuous and moderately calcified artery.A 10mmx2.50mm wolverine coronary cutting balloon was selected for use.During the procedure, it was noted that the balloon ruptured upon inflation at 5 atmospheres for about 20 seconds.The procedure was completed with a different device.There was no patient injury.It was further reported that the balloon ruptured upon first inflation.The balloon was completely removed from the patient's body without problems.
 
Event Description
It was reported that the balloon ruptured.The target lesion was located in the moderately tortuous and moderately calcified artery.A 10mmx2.50mm wolverine coronary cutting balloon was selected for use.During the procedure, it was noted that the balloon ruptured upon inflation at 5 atmospheres for about 20 seconds.The procedure was completed with a different device.There was no patient injury.It was further reported that the balloon ruptured upon first inflation.The balloon was completely removed from the patient's body without problems.
 
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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
two scimed place
maple grove MN 55311
Manufacturer (Section G)
BOSTON SCIENTIFIC CORPORATION
ballybrit business park
galway
EI  
Manufacturer Contact
jay johnson johnson
two scimed place
maple grove, MN 55311
7634942574
MDR Report Key12852418
MDR Text Key281084990
Report Number2134265-2021-14623
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,Followup
Report Date 12/22/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received11/22/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Expiration Date07/21/2023
Device Model Number3851
Device Catalogue Number3851
Device Lot Number0027708896
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer11/24/2021
Is the Reporter a Health Professional? Yes
Date Manufacturer Received12/16/2021
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured07/21/2021
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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