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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 3852
Device Problems Difficult to Remove (1528); Detachment of Device or Device Component (2907)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 06/08/2022
Event Type  malfunction  
Manufacturer Narrative
Initial reporter address 1: (b)(6).
 
Event Description
It was reported that the balloon was detached from the shaft.A 15mmx3.00mm wolverine coronary cutting balloon was selected for post-dilation following stent placement.A slight resistance was noted when attempting to remove the device after inflation within the stent.A push and pull was performed, and the shaft was removed.However, the blade part of the balloon was separated when removed and the balloon remained in the patient's body.The shaft was not detached, but the balloon was torn off from the shaft and fell out.The physician used a guidewire to entangle the balloon portion and the device was recovered with no broken pieces remaining in the patient's body.The procedure was completed with another of the same device.There were no complications and adverse effect reported.
 
Event Description
It was reported that the balloon was detached from the shaft.A 15mmx3.00mm wolverine coronary cutting balloon was selected for post-dilation following stent placement.A slight resistance was noted when attempting to remove the device after inflation within the stent.A push and pull was performed, and the shaft was removed.However, the blade part of the balloon was separated when removed and the balloon remained in the patient's body.The shaft was not detached, but the balloon was torn off from the shaft and fell out.The physician used a guidewire to entangle the balloon portion and the device was recovered with no broken pieces remaining in the patient's body.The procedure was completed with another of the same device.There were no complications and adverse effect reported.
 
Manufacturer Narrative
E1.Initial reporter address (b)(6).Device evaluated by manufacturer: the wolverine cb mr, ous 15mm x 3.00mm catheter was returned for analysis.The device was returned with a portion of the outer lumen broken approximately 20mm proximal from the proximal marker band, the full balloon and the tip detached.The balloon portion containing the outer lumen was returned on a 0.014 inches guidewire.This was removed without issue.The returned detached balloon was found to have solidified blood inside the balloon material.This portion of the device was placed in the water bath to allow the blood to soften and to allow for the material to be analyzed.Once removed, a visual and microscopic examination was completed on the detached balloon and blades.Blade 1 had no issues noted.Blade 2 displayed a 1mm of the mid blade segment missing at the proximal break point and a blade lift noted on the distal blade segment at distal break point.Blade 3 displayed a 1mm of the distal blade segment missing at the distal break point.No holes or tears noted on the balloon portion of the detached material.The tip of the distal was returned intact with no damage on the detached portion of the device.A visual and tactile examination identified multiple hypotube kinks.
 
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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 Key14918975
MDR Text Key303421012
Report Number2134265-2022-07205
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
Report Date 08/03/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received07/05/2022
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model Number3852
Device Catalogue Number3852
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer06/22/2022
Is the Reporter a Health Professional? Yes
Date Manufacturer Received07/14/2022
Was Device Evaluated by Manufacturer? Yes
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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