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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 Leak/Splash (1354)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 07/28/2022
Event Type  malfunction  
Event Description
It was reported that a retrograde bleeding in the shaft occurred.The 90% stenosed target lesion was located in the mildly tortuous and severely calcified left anterior descending artery.A 10mmx2.25mm wolverine coronary cutting balloon was selected for use.During the procedure, the balloon was inflated four times at 6atm within 30 seconds.However, retrograde bleeding was observed in the shaft.The device was simply removed without issue.The procedure was completed with the original device.No patient complications were reported.
 
Event Description
It was reported that a retrograde bleeding in the shaft occurred.The 90% stenosed target lesion was located in the mildly tortuous and severely calcified left anterior descending artery.A 10mmx2.25mm wolverine coronary cutting balloon was selected for use.During the procedure, the balloon was inflated four times at 6atm within 30 seconds.However, retrograde bleeding was observed in the shaft.The device was simply removed without issue.The procedure was completed with the original device.No patient complications were reported.
 
Manufacturer Narrative
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 was a large build-up of blood inside the balloon and inflation lumen.A microscopic examination of the balloon material and markerbands 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, microscopic and tactile examination found no kinks or damages along the length of the hypotube.An examination of the inner / guidewire lumen identified damage 1cm proximal from the tip.The lumen was flattened.As a result of this damage to the lumen, it was not possible to pass a 0.014inch size guidewire through the inner / wire lumen.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.As a result of the build-up of solidified blood, the device was soaked overnight in a water bath at 37 degrees celsius.When an attempt was made to inflate the balloon, liquid leaked out through the tip.The leak is consistent with a puncture hole in the inner / wire lumen, located 1cm proximal to the tip.No other issues were identified during the product analysis.
 
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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 IRELAND LIMITED
ballybrit business park
galway
EI  
Manufacturer Contact
jay johnson
4100 hamline ave n
arden hills, MN 55112
6515810888
MDR Report Key15242261
MDR Text Key300049945
Report Number2124215-2022-30932
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 09/22/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received08/17/2022
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model Number3851
Device Catalogue Number3851
Device Lot Number0029615481
Was Device Available for Evaluation? Device Returned to Manufacturer
Is the Reporter a Health Professional? Yes
Date Manufacturer Received09/15/2022
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured06/18/2022
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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