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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 Advance (2920); Device Dislodged or Dislocated (2923)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 01/11/2019
Event Type  malfunction  
Manufacturer Narrative
Age at time of event: 18 years or older.
 
Event Description
It was reported partial blade detachment occurred.The 75% stenosed target lesion was located in the moderately calcified, moderately tortuous, distal right coronary artery (rca).While attempting to advance a 10 mm x 2.25 mm wolverine coronary cutting balloon monorail into a 6 french 25 cm guidezilla ii, resistance was felt while the device was still outside of the patient.When the wolverine was removed from the guidezilla, it was noticed a blade was partially detached.The procedure was completed with a non bsc device successfully.No patient complications were reported in relation to this event.
 
Event Description
It was reported partial blade detachment occurred.The 75% stenosed target lesion was located in the moderately calcified, moderately tortuous, distal right coronary artery (rca).While attempting to advance a 10 mm x 2.25 mm wolverine coronary cutting balloon monorail into a 6 french 25 cm guidezilla ii, resistance was felt while the device was still outside of the patient.When the wolverine was removed from the guidezilla, it was noticed a blade was partially detached.The procedure was completed with a non bsc device successfully.No patient complications were reported in relation to this event.
 
Manufacturer Narrative
Age at time of event: 18 years or older.Device evaluated by mfr: based on the potential root causes identified, the following attributes were examined: the recommended guide size for this wolverine device is a minimum of a 5fr guide.On analysis, the investigator was unable to advance the device through a boston scientific guide due to a tear on the balloon material and partial blade detachment.The customers guidezilla catheter was not returned for analysis.A visual and microscopic examination was performed on the returned device.It was noted that a section of one of the blades and its blade pad approximately 9mm in length was lifted from the distal end of the balloon material and lifted proximally.The remaining section of blade and blade pad measuring approximately 1mm in length was undamaged and fully bonded to the balloon material.The entire 10mm of blade and blade pad was accounted for.The damage identified can potentially be a result of the resistance encountered while attempting to advance the device through the guide.All other blades were intact and fully bonded to the balloon material.No issues were noted with the blades or pads that could have contributed to the complaint incident.A visual and microscopic examination of the balloon noted a balloon longitudinal tear beginning approximately 1mm distal to the distal edge of the distal markerband and extending approximately 7mm proximally across the balloon material.The tear was noted to be located beneath one of the blade pads.An examination of the distal markerband identified no issues which could potentially have contributed to this complaint.No issue was observed with the tip or markerbands of the device which could have contributed to the complaint incident.A visual and tactile examination identified no kinks or issues along the length of the device.No other issues were identified during the product analysis.
 
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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 Key8312001
MDR Text Key135225690
Report Number2134265-2019-00735
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,distri
Type of Report Initial,Followup
Report Date 03/21/2019
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 Date11/01/2020
Device Model Number3851
Device Catalogue Number3851
Device Lot Number0022883982
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer01/31/2019
Initial Date Manufacturer Received 01/15/2019
Initial Date FDA Received02/06/2019
Supplement Dates Manufacturer Received03/08/2019
Supplement Dates FDA Received03/21/2019
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Treatment
GUIDEZILLA II; GUIDEZILLA II; GUIDEZILLA II
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