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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 3850
Device Problem Leak/Splash (1354)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 01/18/2023
Event Type  malfunction  
Event Description
It was reported that a balloon leak was observed.The 90% stenosed target lesion was located in the severely tortuous and severely calcified left circumflex artery.A 6mmx2.00mm wolverine coronary cutting balloon was selected for use.The indeflator was connected to the device and the device was inserted into the guiding catheter.Negative pressure was applied and blood backflow was observed.The balloon was removed from the patient's body without any problem using the normal method and the procedure was completed with a different device.No patient complications were reported, and the patient was in good condition after the procedure.
 
Manufacturer Narrative
Device evaluated by mfr: the complaint device was received for product analysis.A visual and microscopic examination of the balloon identified no tears or holes in the balloon material.All blades were intact within their pads and fully bonded to the balloon material.A visual and tactile examination identified no issues with the hypotube.A visual and microscopic examination of the distal extrusion identified a jagged tear in the inner and outer extrusions.The tear stretched from the guidewire exit port and extended distally for 3.2cm in length.As a result of the damage to the extrusion it was not possible to inflate the balloon.Liquid leaked out through the tear site.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.No other issues were identified during the product analysis.
 
Event Description
It was reported that a balloon leak was observed.The 90% stenosed target lesion was located in the severely tortuous and severely calcified left circumflex artery.A 6mmx2.00mm wolverine coronary cutting balloon was selected for use.The indeflator was connected to the device and the device was inserted into the guiding catheter.Negative pressure was applied and blood backflow was observed.The balloon was removed from the patient's body without any problem using the normal method and the procedure was completed with a different device.No patient complications were reported, and the patient was in good condition after the procedure.
 
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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
jeff wallner
4100 hamline ave n
arden hills, MN 55112
6515811560
MDR Report Key16342721
MDR Text Key309275382
Report Number2124215-2023-03444
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
Reporter Occupation Physician
Type of Report Initial,Followup
Report Date 03/31/2023
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 Model Number3850
Device Catalogue Number3850
Device Lot Number0029804118
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer02/09/2023
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 01/18/2023
Initial Date FDA Received02/09/2023
Supplement Dates Manufacturer Received03/10/2023
Supplement Dates FDA Received03/31/2023
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured07/21/2022
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
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