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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 Problems Inflation Problem (1310); Material Rupture (1546)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 02/16/2021
Event Type  malfunction  
Manufacturer Narrative
(b)(6).
 
Event Description
It was reported that the balloon ruptured.The 90% stenosed target lesion area was located in a mildly tortuous and mildly calcified left anterior descending artery.A 10mmx2.50mm wolverine coronary cutting balloon was selected for use in a percutaneous coronary intervention.During the procedure, the device crossed the lesion successfully.However, it was noted that the balloon could not be inflated as it was already ruptured.The device was removed, and the procedure was completed with another of the same device.There were no patient complications reported.
 
Manufacturer Narrative
E1.Initial reporter city: (b)(6).Device evaluated by manufacturer: the device was returned for analysis.A visual examination identified that the balloon was not folded which indicates that the balloon was subjected to positive pressure.There were traces of blood visible inside the balloon.The returned device was attached to an encore inflation unit and positive pressure was applied in an attempt to inflate the balloon.The balloon could not be inflated due to the presence of solidified blood.The device was soaked in a water bath at a temperature of 37 degrees celsius to help soften the blood before further inflation attempts were made.The device was removed from the bath and the balloon was again attached to an inflation device subjected to positive pressure and liquid was observed to be leaking from a balloon pinhole located at the site of the proximal maker band.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 found no kinks or damage to the hypotube or shaft of the device.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 90% stenosed target lesion area was located in a mildly tortuous and mildly calcified left anterior descending artery.A 10mmx2.50mm wolverine coronary cutting balloon was selected for use in a percutaneous coronary intervention.During the procedure, the device crossed the lesion successfully.However, it was noted that the balloon could not be inflated as it was already ruptured.The device was removed, and the procedure was completed with another of the same device.There were 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
two scimed place
maple grove MN 55311
MDR Report Key11391794
MDR Text Key234012923
Report Number2134265-2021-02295
Device Sequence Number1
Product Code NWX
Combination Product (y/n)N
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,distri
Type of Report Initial,Followup
Report Date 03/23/2021
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 Date11/24/2022
Device Model Number3851
Device Catalogue Number3851
Device Lot Number0026412436
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer03/02/2021
Initial Date Manufacturer Received 02/16/2021
Initial Date FDA Received03/01/2021
Supplement Dates Manufacturer Received03/18/2021
Supplement Dates FDA Received03/23/2021
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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