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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 Entrapment of Device (1212); Adverse Event Without Identified Device or Use Problem (2993)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 10/29/2021
Event Type  malfunction  
Event Description
It was reported that the balloon got stuck in the stent.A 15mmx2.75mm wolverine coronary cutting balloon was selected for use.During the procedure, it was noted that the wolverine got stuck and could not be removed by inflating.The balloon was inflated sideways and the approach was changed, but it could not be removed; however, after second attempt, it was released from being stuck.The procedure was completed with the original device.There were no patient complications reported.
 
Manufacturer Narrative
Device evaluated by mfr: a 15mmx2.75mm wolverine cutting balloon was returned for analysis.A visual and microscopic examination identified that the balloon was returned in a deflated state.The balloon had been subjected to positive pressure.3 blades were present on the balloon surface however the following blade damage was noted: blade 1: the blade was fully intact and bonded to the balloon.There was no issue with the balloon pad.Blade 2: the blade was fully intact and bonded to the balloon.There was no issue with the balloon pad.Blade 3: slight blade lift noted on the distal end of the proximal blade segment and also on the proximal end of the distal blade segment.There was no issue with the balloon pad.A visual and tactile examination found no kinks present along the hypotube.A visual and tactile examination found no damage along the shaft polymer extrusion.No issues were noted with the tip of the device or markerbands.
 
Event Description
It was reported that the balloon got stuck in the stent.A 15mmx2.75mm wolverine coronary cutting balloon was selected for use.During the procedure, it was noted that the wolverine got stuck and could not be removed by inflating.The balloon was inflated sideways and the approach was changed, but it could not be removed; however, after second attempt, it was released from being stuck.The procedure was completed with the original 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
Manufacturer (Section G)
BOSTON SCIENTIFIC CORPORATION
ballybrit business park
galway
EI  
Manufacturer Contact
jay johnson
two scimed place
maple grove, MN 55311
7634942574
MDR Report Key12745555
MDR Text Key279867551
Report Number2134265-2021-13822
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 12/08/2021
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 Date07/05/2023
Device Model Number3852
Device Catalogue Number3852
Device Lot Number0027610002
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer11/15/2021
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 10/29/2021
Initial Date FDA Received11/03/2021
Supplement Dates Manufacturer Received12/03/2021
Supplement Dates FDA Received12/08/2021
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured07/05/2021
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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