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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 3852
Device Problems Inflation Problem (1310); Detachment of Device or Device Component (2907)
Patient Problem Device Embedded In Tissue or Plaque (3165)
Event Date 10/05/2020
Event Type  Injury  
Event Description
It was reported that the blade separated and remained inside patient.The 90%, in-stent re-stenosed target lesion was located in the mildly tortuous and severely calcified left anterior descending (lad) artery.A 15mmx3.00mm wolverine coronary cutting balloon was used.During procedure, a 2.0/15 non-boston scientific product was advanced after an unknown wire crossed the area and laser was performed.Subsequently, the balloon was delivered and inflated at 12atm, 6atm, 6atm, 6atm and 12atm respectively, but failed.A diamond back was performed in the mid lad.The effect of ablation was sufficiently obtained.This device was delivered again, and dilation was performed 13 times (repeated 6atm to 18atm).After retrieval, it was noticed that the blade was separated.On the first usage, it was not separated, so it was certain that it became separated on the second usage.It could not be seen by fluoroscopy, so it could not be retrieved and remained in the body.The procedure was completed by a drug coated balloon.No further patient complications were reported, and patient was in good condition.
 
Event Description
It was reported that the blade separated and remained inside patient.The 90%, in-stent re-stenosed target lesion was located in the mildly tortuous and severely calcified left anterior descending (lad) artery.A 15mmx3.00mm wolverine coronary cutting balloon was used.During procedure, a 2.0/15 non-boston scientific product was advanced after an unknown wire crossed the area and laser was performed.Subsequently, the balloon was delivered and inflated at 12atm, 6atm, 6atm, 6atm and 12atm respectively, but failed.A diamond back was performed in the mid lad.The effect of ablation was sufficiently obtained.This device was delivered again, and dilation was performed 13 times (repeated 6atm to 18atm).After retrieval, it was noticed that the blade was separated.On the first usage, it was not separated, so it was certain that it became separated on the second usage.It could not be seen by fluoroscopy, so it could not be retrieved and remained in the body.The procedure was completed by a drug coated balloon.No further patient complications were reported, and patient was in good condition.
 
Manufacturer Narrative
The device was returned for analysis.A visual examination identified that the balloon was returned in a deflated state.The balloon had been subjected to positive pressure.Three blades were present on the balloon surface, however, blade damage was noted.The midsection of the first blade was detached from the pad; the distance from break point to break point measured approximately 5mm.The pad remained attached and secure to the balloon material.The distal section of the second blade was detached; the distance from the break point to the distal edge of the pad was approximately 5mm.The pad remained attached and secure to balloon material.The proximal end of the mid blade section was found to be lifted from the pad.Areas of lift had occurred through the third blade.The third blade remained in the pad and the pad was secure to the balloon material.A visual and tactile examination found no issues with the shaft of this device.No issues were noted with the tip of the device.A visual and microscopic examination found no issue with the marker bands.
 
Manufacturer Narrative
F10 and h6 device codes corrected.
 
Event Description
It was reported that the blade separated and remained inside patient.The 90%, in-stent re-stenosed target lesion was located in the mildly tortuous and severely calcified left anterior descending (lad) artery.A 15mmx3.00mm wolverine coronary cutting balloon was used.During procedure, a 2.0/15 non-boston scientific product was advanced after an unknown wire crossed the area and laser was performed.Subsequently, the balloon was delivered and inflated at 12atm, 6atm, 6atm, 6atm and 12atm respectively, but failed.A diamond back was performed in the mid lad.The effect of ablation was sufficiently obtained.This device was delivered again, and dilation was performed 13 times (repeated 6atm to 18atm).After retrieval, it was noticed that the blade was separated.On the first usage, it was not separated, so it was certain that it became separated on the second usage.It could not be seen by fluoroscopy, so it could not be retrieved and remained in the body.The procedure was completed by a drug coated balloon.No further patient complications were reported, and patient was in good condition.
 
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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 Key10742069
MDR Text Key213259972
Report Number2134265-2020-14751
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 12/07/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received10/27/2020
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Expiration Date04/27/2022
Device Model Number3852
Device Catalogue Number3852
Device Lot Number0025474427
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer10/22/2020
Date Manufacturer Received11/19/2020
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Treatment
BALLOON CATHETER- RYUREI 2.0/15; BALLOON CATHETER- RYUREI 2.0/15; BALLOON CATHETER- RYUREI 2.0/15; DRUG COATED BALLOON- SEQUENT PLEASE; DRUG COATED BALLOON- SEQUENT PLEASE; DRUG COATED BALLOON- SEQUENT PLEASE; GUIDE CATHETER- HYPERION 7F SPB; GUIDE CATHETER- HYPERION 7F SPB; GUIDE CATHETER- HYPERION 7F SPB; IMAGING CATHETER- OCHD; IMAGING CATHETER- OCHD; IMAGING CATHETER- OCHD; BALLOON CATHETER- RYUREI 2.0/15; DRUG COATED BALLOON- SEQUENT PLEASE; GUIDE CATHETER- HYPERION 7F SPB; IMAGING CATHETER- OCHD
Patient Outcome(s) Required Intervention;
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