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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 Insert (1316); Material Rupture (1546)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 02/26/2021
Event Type  malfunction  
Manufacturer Narrative
Initial reporter city: (b)(6).
 
Event Description
It was reported that a balloon rupture occurred.The target lesion was located in a moderately tortuous and moderately calcified left main trunk.A 10mmx4.00mm wolverine coronary cutting balloon was selected for use.During procedure, there was resistance when the device was inserted.When the proximal part of the balloon was inflated, delivery was performed with care.The first pressure was applied at 12atm for 5 seconds and second pressure was applied; however, it was noted that the balloon ruptured.The device was removed intact from the patient's body and the procedure was completed with a different device.No patent complications were reported.
 
Manufacturer Narrative
E1 - initial reporter city: (b)(6).Device evaluated by mfr: the device was returned for evaluation.A visual examination identified that the balloon was not folded which indicates that the balloon was subjected to positive pressure.The returned device was attached to an encore inflation unit and positive pressure was applied in an attempt to inflate the balloon.Liquid was observed to be leaking from a balloon pinhole located at 5mm distal to the proximal marker band at the site of a blade segment lift.An examination of the balloon material and markerbands identified no issues which could potentially have contributed to this complaint.The rated burst pressure for this device is 12 atmospheres.One blade found to be lifted out of its pad at the break point.Pad and remaining blade segment found to be secured to the balloon material surface.No issues identified with any other blades.A visual and tactile examination found no issues with the hypotube of this device.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.
 
Event Description
It was reported that a balloon rupture occurred.The target lesion was located in a moderately tortuous and moderately calcified left main trunk.A 10mmx4.00mm wolverine coronary cutting balloon was selected for use.During procedure, there was resistance when the device was inserted.When the proximal part of the balloon was inflated, delivery was performed with care.The first pressure was applied at 12atm for 5 seconds and second pressure was applied; however, it was noted that the balloon ruptured.The device was removed intact from the patient's body and the procedure was completed with a different device.No patent complications were reported.It was further reported that there was resistance when inserting the device into the y-connector.
 
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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
MDR Report Key11476142
MDR Text Key239702967
Report Number2134265-2021-03276
Device Sequence Number1
Product Code NWX
Combination Product (y/n)N
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Type of Report Initial,Followup
Report Date 04/22/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received03/12/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Expiration Date10/14/2022
Device Model Number3851
Device Catalogue Number3851
Device Lot Number0026182177
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer03/09/2021
Date Manufacturer Received03/31/2021
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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