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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 Problems Difficult to Remove (1528); Device Dislodged or Dislocated (2923)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 04/14/2022
Event Type  malfunction  
Event Description
It was reported that blade lifted and stuck in lesion occurred.The patient presented with angina.The 90% stenosed target lesion was located in the mildly tortuous and severely calcified posterior descending branch.A 10mmx2.00mm wolverine coronary cutting balloon was selected for use.During the procedure, the wolverine was repeatedly inflated in the lesion and strong resistance was felt when it was pulled out from the blood vessel.It seems that the device was stuck in the lesion, but the guiding position was adjusted to improve the alignment and the catheter was recovered with nothing remaining inside the patient.Upon checking the recovered balloon, it was noted that the blade was lifted.The procedure was completed with a different device.There was no patient injury.
 
Manufacturer Narrative
The device was returned for analysis.A visual examination identified that the balloon was returned in a deflated state with media present inside the balloon material.The balloon had been subjected to positive pressure.Three blades were present on the balloon surface however the following blade damage was noted on two blades: blade 1 had a 3mm portion of the distal blade segment missing from the blade pad.The blade pad was found to be fully intact to the balloon surface.Blade 2 had a blade lift noted on the distal blade segment at the break point.The blade pad was found to be fully intact to the balloon surface.A visual and tactile examination identified multiple hypotube kinks.No issues were noted with the tip of the device.A visual and microscopic examination found no issue with the marker bands.No other issues were identified during the product analysis.
 
Event Description
It was reported that blade lifted and stuck in lesion occurred.The patient presented with angina.The 90% stenosed target lesion was located in the mildly tortuous and severely calcified posterior descending branch.A 10mmx2.00mm wolverine coronary cutting balloon was selected for use.During the procedure, the wolverine was repeatedly inflated in the lesion and strong resistance was felt when it was pulled out from the blood vessel.It seems that the device was stuck in the lesion, but the guiding position was adjusted to improve the alignment and the catheter was recovered with nothing remaining inside the patient.Upon checking the recovered balloon, it was noted that the blade was lifted.The procedure was completed with a different device.There was no patient injury.
 
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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 Key14247065
MDR Text Key290373761
Report Number2134265-2022-04850
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 06/15/2022
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 Date03/06/2024
Device Model Number3851
Device Catalogue Number3851
Device Lot Number0028999888
Was Device Available for Evaluation? Device Returned to Manufacturer
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 04/14/2022
Initial Date FDA Received04/28/2022
Supplement Dates Manufacturer Received06/14/2022
Supplement Dates FDA Received06/15/2022
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured03/07/2022
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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