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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION WOLVERINE CORONARY CUTTING BALLOON; CATHETER, PERCUTANEOUS TRANSLUMINAL CORONARY ANGIOPLASTY (PTCA), CUTTING/SCORING
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BOSTON SCIENTIFIC CORPORATION WOLVERINE CORONARY CUTTING BALLOON; CATHETER, PERCUTANEOUS TRANSLUMINAL CORONARY ANGIOPLASTY (PTCA), CUTTING/SCORING Back to Search Results
Model Number 3854
Device Problem Material Rupture (1546)
Patient Problem Arrhythmia (1721)
Event Date 09/02/2022
Event Type  Injury  
Event Description
It was reported that the patient had arrhythmia.The 85% stenosed target lesion was located in the non-tortuous and non-calcified left anterior descending artery.A 10mmx3.00mm wolverine coronary cutting balloon was selected for use.During the procedure, the physician thought device rupture occurred at 6 atmospheres upon first inflation for 5 seconds because contrast from balloon went down vessel.Therefore, pre existing air in balloon is possible.The balloon was taken out and medication was given.The procedure was completed with another of the same device.The patient had arrhythmia but has fully recovered.
 
Event Description
It was reported that the patient had arrhythmia.The 85% stenosed target lesion was located in the non-tortuous and non-calcified left anterior descending artery.A 10mmx3.00mm wolverine coronary cutting balloon was selected for use.During the procedure, the physician thought device rupture occurred at 6 atmospheres upon first inflation for 5 seconds because contrast from balloon went down vessel.Therefore, pre existing air in balloon is possible.The balloon was taken out and medication was given.The procedure was completed with another of the same device.The patient had arrhythmia but has fully recovered.
 
Manufacturer Narrative
Device evaluated by manufacturer: the device was returned for analysis.A visual examination identified that the balloon was returned with its wings 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 in the balloon mid-section.An examination of the balloon material and marker bands identified no issues which could potentially have contributed to this complaint.The rated burst pressure for this device is 12 atmospheres as per wolverine ifu.All blades were intact within their pads and fully bonded to the balloon material.A visual and tactile examination identified multiple hypotube kinks.A visual and tactile examination identified no issues on the shaft polymer extrusion.The marker bands 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.
 
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Brand Name
WOLVERINE CORONARY CUTTING BALLOON
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 IRELAND LIMITED
ballybrit business park
galway
EI  
Manufacturer Contact
jay johnson
4100 hamline ave n
arden hills, MN 55112
6515810888
MDR Report Key15420375
MDR Text Key299885753
Report Number2124215-2022-35747
Device Sequence Number1
Product Code NWX
UDI-Device Identifier08714729888260
UDI-Public08714729888260
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
P950020
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Foreign,Health Professional,Company Representative
Reporter Occupation Physician
Type of Report Initial,Followup
Report Date 10/24/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received09/14/2022
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model Number3854
Device Catalogue Number3854
Device Lot Number0029650701
Was Device Available for Evaluation? Device Returned to Manufacturer
Is the Reporter a Health Professional? Yes
Date Manufacturer Received10/14/2022
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured06/24/2022
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
Patient Outcome(s) Required Intervention;
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