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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 Break (1069); Deflation Problem (1149); Difficult to Remove (1528); Detachment of Device or Device Component (2907)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 09/09/2020
Event Type  Injury  
Event Description
It was reported that the balloon was difficult to remove.The target lesion was located in the severely tortuous and severely calcified left circumflex artery.A 10mmx3.00mm wolverine coronary cutting balloon was introduced and during the procedure, the balloon was inflated once up to 12atm.After inflation, an attempt was made to remove the device but the balloon might not have been completely deflated and it became stuck.Eventually, the shaft was cut and the device was covered with a guide extension catheter which enabled the devices to be removed together.Once the balloon was outside the patient, it was noted that a blade fragment was missing.Intravascular ultrasound was used to check for the blade, but it was not found inside the patient.This completed the procedure.There was no patient injury.
 
Event Description
It was reported that the balloon was difficult to remove.The target lesion was located in the severely tortuous and severely calcified left circumflex artery.A 10mmx3.00mm wolverine coronary cutting balloon was introduced and during the procedure, the balloon was inflated once up to 12atm.After inflation, an attempt was made to remove the device but the balloon might not have been completely deflated and it became stuck.Eventually, the shaft was cut and the device was covered with a guide extension catheter which enabled the devices to be removed together.Once the balloon was outside the patient, it was noted that a blade fragment was missing.Intravascular ultrasound was used to check for the blade, but it was not found inside the patient.This completed the procedure.There was no patient injury.
 
Manufacturer Narrative
Device evaluated by mfr: the device was returned for analysis.A visual examination identified that the balloon was not folded which indicates that the balloon was subjected to positive pressure.A blade segment from one of the blades was found to be missing from its pad and 1mm of the pad segment which had contained the missing blade segment, was raised distally from the balloon material.The remainder of the pad and the blade were found to be securely bonded to the balloon material.All other blades were found to be securely bonded to the balloon material.The device was returned with its hub removed.The hub was not returned with the device.Multiple kinks were noted along the length of the device.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.
 
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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 Key10617366
MDR Text Key209563166
Report Number2134265-2020-13236
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 11/10/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Expiration Date06/11/2022
Device Model Number3851
Device Catalogue Number3851
Device Lot Number0025588282
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer09/30/2020
Initial Date Manufacturer Received 09/11/2020
Initial Date FDA Received10/01/2020
Supplement Dates Manufacturer Received10/22/2020
Supplement Dates FDA Received11/10/2020
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Treatment
STENT - S670; STENT - S670
Patient Outcome(s) Required Intervention;
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