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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 01/30/2019
Event Type  malfunction  
Manufacturer Narrative
Age at time of event: 18 years or older.
 
Event Description
It was reported that insertion was difficult and a blade lifted.A percutaneous coronary intervention was being performed on a 90% stenosed, moderately calcified and severely tortuous lesion in the circumflex ostium at the branch in the left main artery.The 10mm x 2.75mm wolverine coronary cutting balloon was used twice for dilation.The balloon was then removed and ivus was performed.The lesion was noted to be insufficiently dilated so a third dilation was performed after rewrapping of the balloon outside the body.During insertion, resistance was felt.Upon removal, a blade was found to be lifted.The procedure was successfully completed with a different device without issue or patient injury.
 
Event Description
It was reported that insertion was difficult and a blade lifted.A percutaneous coronary intervention was being performed on a 90% stenosed, moderately calcified and severely tortuous lesion in the circumflex ostium at the branch in the left main artery.The 10mm x 2.75mm wolverine coronary cutting balloon was used twice for dilation.The balloon was then removed and ivus was performed.The lesion was noted to be insufficiently dilated so a third dilation was performed after rewrapping of the balloon outside the body.During insertion, resistance was felt.Upon removal, a blade was found to be lifted.The procedure was successfully completed with a different device without issue or patient injury.
 
Manufacturer Narrative
Age at time of event: 18 years or older.The device was received inside the protective hoop.The recommended guide size for this wolverine device is a minimum of a 5fr guide.On analysis, the investigator successfully advanced the device through a boston scientific 5fr guide and removed it with no resistance experienced.The customers guide was not returned for analysis.A visual and microscopic examination was performed on the returned device.It was noted that one complete blade and blade pad were completely detached from the balloon material of the returned device.Upon inspection, a section of the detached blade and blade pad measuring approximately 5mm in length were found inside the protective hoop prior to the decontamination process.The other section of blade and pad were not returned for analysis.All other blades were intact and fully bonded to the balloon material.A visual and microscopic examination of the balloon and markerbands identified no issues which could potentially have contributed to this complaint.A visual and microscopic examination identified no issues with the tip which could potentially have contributed to this complaint.No other issues were identified during the product analysis.Correction: originally reported device analysis stated that 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.This is now corrected to the investigator successfully advanced the device through a boston scientific 5fr guide and removed it with no resistance experienced.
 
Manufacturer Narrative
Age at time of event: 18 years or older.The device was received inside the protective hoop.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 guide was not returned for analysis.A visual and microscopic examination was performed on the returned device.It was noted that one complete blade and blade pad were completely detached from the balloon material of the returned device.Upon inspection, a section of the detached blade and blade pad measuring approximately 5mm in length were found inside the protective hoop prior to the decontamination process.The other section of blade and pad were not returned for analysis.All other blades were intact and fully bonded to the balloon material.A visual and microscopic examination of the balloon and markerbands identified no issues which could potentially have contributed to this complaint.A visual and microscopic examination identified no issues with the tip which could potentially have contributed to this complaint.No other issues were identified during the product analysis.
 
Event Description
It was reported that insertion was difficult and a blade lifted.A percutaneous coronary intervention was being performed on a 90% stenosed, moderately calcified and severely tortuous lesion in the circumflex ostium at the branch in the left main artery.The 10mm x 2.75mm wolverine coronary cutting balloon was used twice for dilation.The balloon was then removed and ivus was performed.The lesion was noted to be insufficiently dilated so a third dilation was performed after rewrapping of the balloon outside the body.During insertion, resistance was felt.Upon removal, a blade was found to be lifted.The procedure was successfully completed with a different device without issue or 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
MDR Report Key8362379
MDR Text Key136887074
Report Number2134265-2019-01603
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,Followup
Report Date 03/22/2019
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 Date11/08/2020
Device Model Number3851
Device Catalogue Number3851
Device Lot Number22918279
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer02/12/2019
Initial Date Manufacturer Received 01/30/2019
Initial Date FDA Received02/22/2019
Supplement Dates Manufacturer Received03/11/2019
03/20/2019
Supplement Dates FDA Received03/18/2019
03/22/2019
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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