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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 Remove (1528); Material Rupture (1546); Detachment of Device or Device Component (2907)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 10/02/2020
Event Type  malfunction  
Manufacturer Narrative
(b)(6).
 
Event Description
It was reported that the balloon was difficult to remove and balloon rupture occurred.A 10mm x 3.00mm wolverine coronary cutting balloon was selected for use.During procedure, severe resistance was met during removal and the device could not be removed.The physician cut the hub of the wolverine and a guideliner was inserted over the wolverine balloon and pulled out to remove it.A hole in the balloon was also noticed on the device.No patient complications were reported.
 
Manufacturer Narrative
E1: initial reporter address 1:(b)(6).Device evaluated by mfr: the device was returned for evaluation.A visual examination identified that the balloon was returned in a deflated state.The balloon had been subjected to positive pressure.3 blades were present on the balloon surface however the following blade damage was noted: blade 1 - 1 mm of the distal blade segment was missing (missing from break point extending to 1mm in a distal direction).Blade pad remained secure to balloon material.Blade 2 - full distal blade segment missing from pad - pad remains secure to balloon material.Blade 03 - no issues noted.Device returned with hub removed.Shaft polymer extrusion found to be stretched at the guidewire port.No issues were noted with the tip of the device.A visual and microscopic examination found no issue with the markerbands.
 
Event Description
It was reported that the balloon was difficult to remove and balloon rupture occurred.A 10mmx3.00mm wolverine coronary cutting balloon was selected for use.During procedure, severe resistance was met during removal and device could not be removed.The physician cut the hub of wolverine and a guideliner was inserted over the wolverine balloon and pulled out to remove it.Furthermore, a hole in the balloon was also noticed on the device.No patient complications reported.It was further reported that after performing inflation twice at 12atm, removal of the device became difficult.There was no balloon rupture.The catheter was able to be removed; however, the blades were detached and went missing.It is unknown whether the detached blades remained in the body or not.The physician thinks that the possible cause of the missing blade was due to the balloon failed to be retracted into the sheath/guide properly and became difficult to be pulled out then the device was pulled out forcibly.It was then reported that the 90% stenosed, 3.5mm x 20mm target lesion was located in the mildly tortuous, severely calcified left anterior descending artery.The reason why the balloon was unable to be fully deflated is undeterminable.The patient was good post procedure.
 
Event Description
It was reported that the balloon was difficult to remove and balloon rupture occurred.A 10mmx3.00mm wolverine coronary cutting balloon was selected for use.During procedure, severe resistance was met during removal and the device could not be removed.The physician cut the hub of the wolverine and a guideliner was inserted over the wolverine balloon and pulled out to remove it.A hole in the balloon was also noticed on the device.No patient complications were reported.It was further reported that the device was used in the procedure to treat in-stent restenosis.After performing inflation twice at 12atm, removal of the device became difficult.There was no balloon rupture.The catheter was able to be removed; however, the blades were detached and went missing.It is unknown whether the detached blades remained in the body or not.The physician thinks that the possible cause of the missing blade was due to the balloon failed to be retracted into the sheath/guide properly and became difficult to be pulled out then the device was pulled out forcibly.
 
Manufacturer Narrative
E1: initial reporter address 1: (b)(6).
 
Event Description
It was reported that the balloon was difficult to remove and balloon rupture occurred.A 10mmx3.00mm wolverine coronary cutting balloon was selected for use.During procedure, severe resistance was met during removal and device could not be removed.The physician cut the hub of wolverine and a guideliner was inserted over the wolverine balloon and pulled out to remove it.Furthermore, a hole in the balloon was also noticed on the device.No patient complications reported.It was further reported that after performing inflation twice at 12atm, removal of the device became difficult.There was no balloon rupture.The catheter was able to be removed; however, the blades were detached and went missing.It is unknown whether the detached blades remained in the body or not.The physician thinks that the possible cause of the missing blade was due to the balloon failed to be retracted into the sheath/guide properly and became difficult to be pulled out then the device was pulled out forcibly.
 
Manufacturer Narrative
E1: initial reporter address 1: (b)(6).Device evaluated by mfr: the device was returned for evaluation.A visual examination identified that the balloon was returned in a deflated state.The balloon had been subjected to positive pressure.3 blades were present on the balloon surface however the following blade damage was noted: blade 1 - 1 mm of the distal blade segment was missing (missing from break point extending to 1mm in a distal direction).Blade pad remained secure to balloon material.Blade 2 - full distal blade segment missing from pad - pad remains secure to balloon material.Blade 03 - no issues noted.Device returned with hub removed.Shaft polymer extrusion found to be stretched at the guidewire port.No issues were noted with the tip of the device.A visual and microscopic examination found no issue with the markerbands.
 
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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 Key10763095
MDR Text Key213900663
Report Number2134265-2020-14684
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,Followup
Report Date 12/17/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received10/30/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Expiration Date07/10/2022
Device Model Number3851
Device Catalogue Number3851
Device Lot Number0025697221
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer10/29/2020
Date Manufacturer Received12/14/2020
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Age46 YR
Patient Weight76
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