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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); Material Rupture (1546); Detachment of Device or Device Component (2907); Material Twisted/Bent (2981)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 04/26/2022
Event Type  malfunction  
Event Description
It was reported that a balloon rupture and blade damage occurred.The 90% stenosed target lesion was located in the moderately tortuous and moderately calcified mid left anterior descending artery.A 10mmx3.25mm wolverine coronary cutting balloon was selected for use.During the procedure, it was noted that the balloon ruptured upon third inflation at 10 atmospheres within 20 seconds.As the device was being removed, mild resistance was noted when pulling it back to a non-boston scientific guide catheter.Once removed, it was noted that a part of the blade was crimped.Inspection of the device revealed the blades were complete and no fragment was left inside the patient.The procedure was completed with another of same device.No complications were reported and patient was good post procedure.
 
Event Description
It was reported that a balloon rupture and blade damage occurred.The 90% stenosed target lesion was located in the moderately tortuous and moderately calcified mid left anterior descending artery.A 10mmx3.25mm wolverine coronary cutting balloon was selected for use.During the procedure, it was noted that the balloon ruptured upon third inflation at 10 atmospheres within 20 seconds.As the device was being removed, mild resistance was noted when pulling it back to a non-boston scientific guide catheter.Once removed, it was noted that a part of the blade was crimped.Inspection of the device revealed the blades were complete and no fragment was left inside the patient.The procedure was completed with another of same device.No complications were reported and patient was good post procedure.
 
Manufacturer Narrative
H6 device codes: corrected the wolverine cb mr, ous 10mmx3.25mm was returned for analysis.A visual examination revealed the balloon was returned in a deflated state with media present inside the balloon material and that the balloon had been subjected to positive pressure.The returned device was attached to a boston scientific encore inflation unit and positive pressure was applied.The balloon was inflated to its rated burst pressure (rbp) and pressure was held for 30 seconds without issue; a vacuum was then applied.This inflation to rbp was repeated three times with no leaks or drop in pressure noted.Two blades were present and secured within their pads.Both pads were intact on the balloon surface.One blade and pad were returned detached from the balloon surface.This blade was completely intact within the pad.The pad and touch up were found to be completely intact.A visual and tactile examination identified no issues.No issues were noted with the tip of the device.A visual and microscopic examination found no issue with the marker bands.
 
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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 johnson
two scimed place
maple grove, MN 55311
7634942574
MDR Report Key14340767
MDR Text Key291291688
Report Number2134265-2022-05277
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 06/17/2022
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 Date03/10/2024
Device Model Number3851
Device Catalogue Number3851
Device Lot Number0029030409
Was Device Available for Evaluation? Device Returned to Manufacturer
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 04/26/2022
Initial Date FDA Received05/09/2022
Supplement Dates Manufacturer Received06/16/2022
Supplement Dates FDA Received06/17/2022
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured03/11/2022
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
Treatment
GUIDE CATHETER - 6FR HYPERION; GUIDE CATHETER - 6FR HYPERION
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