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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 Break (1069); Detachment of Device or Device Component (2907); Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Bradycardia (1751); Chest Pain (1776)
Event Date 11/10/2022
Event Type  Injury  
Event Description
It was reported a device fracture occurred, followed by chest pain and slow heart rate in the patient.During a percutaneous coronary intervention (pci) to the left anterior descending (lad) artery, a wolverine coronary cutting balloon was selected for use to prepare the vessel.The catheter engaged as expected, the wire and the balloon both crossed the narrowing and aligned into the desired position.A small amount of resistance was noted when pulling back into a proximal position, when the balloon was attempted to be inflated, no inflation was present.The balloon was then attempted to be withdrawn from the vessel, at which point it was confirmed the device had snapped off around a third of the way into the wire part of the device and the balloon moved further into the vessel.While further equipment was prepared for retrieval, the patient heart rate slowed, and chest pain was felt.Pain relief and atropine were given to stabilize the patient.A new wire and balloon were passed to the very distal end of the vessel, slightly inflated and retrieved into the catheter.The fractured device was successfully removed.No further harm was caused to the patient and the vessel remained stable.The pci was performed successfully and the patient remained stable upon recovery and was discharged the same day without concern.
 
Event Description
It was reported a device fracture occurred, followed by chest pain and slow heart rate in the patient.During a percutaneous coronary intervention (pci) to the left anterior descending (lad) artery, a wolverine coronary cutting balloon was selected for use to prepare the vessel.The catheter engaged as expected, the wire and the balloon both crossed the narrowing and aligned into the desired position.A small amount of resistance was noted when pulling back into a proximal position, when the balloon was attempted to be inflated, no inflation was present.The balloon was then attempted to be withdrawn from the vessel, at which point it was confirmed the device had snapped off around a third of the way into the wire part of the device and the balloon moved further into the vessel.While further equipment was prepared for retrieval, the patient heart rate slowed, and chest pain was felt.Pain relief and atropine were given to stabilize the patient.A new wire and balloon were passed to the very distal end of the vessel, slightly inflated and retrieved into the catheter.The fractured device was successfully removed.No further harm was caused to the patient and the vessel remained stable.The pci was performed successfully and the patient remained stable upon recovery and was discharged the same day without concern.
 
Manufacturer Narrative
Correction: h6 device code.
 
Manufacturer Narrative
Correction: h6 device code device evaluated by manufacturer: a wolverine cb mr, ous 15mmx3.00mm, catheter 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 microscopic examination of the balloon material and markerbands identified no issues which could potentially have contributed to this complaint.All blades were intact within their pads and fully bonded to the balloon material.The device was received in two sections as a result of a break in the hypotube.The break was located at 44cm distal from the strain relief.A microscopic examination of the break site identified no issues with the hypotube which could potentially have contributed to the break.Both sections of the hypotube were kinked at various locations along their lengths.An examination of the distal extrusion identified no damages.The markerbands and tip and of the device were visually and microscopically examined, and no issues were noted with the device that may have potentially contributed to the complaint incident.No other issues were identified during the product analysis.
 
Event Description
It was reported a device fracture occurred, followed by chest pain and slow heart rate in the patient.During a percutaneous coronary intervention (pci) to the left anterior descending (lad) artery, a wolverine coronary cutting balloon was selected for use to prepare the vessel.The catheter engaged as expected, the wire and the balloon both crossed the narrowing and aligned into the desired position.A small amount of resistance was noted when pulling back into a proximal position, when the balloon was attempted to be inflated, no inflation was present.The balloon was then attempted to be withdrawn from the vessel, at which point it was confirmed the device had snapped off around a third of the way into the wire part of the device and the balloon moved further into the vessel.While further equipment was prepared for retrieval, the patient heart rate slowed, and chest pain was felt.Pain relief and atropine were given to stabilize the patient.A new wire and balloon were passed to the very distal end of the vessel, slightly inflated and retrieved into the catheter.The fractured device was successfully removed.No further harm was caused to the patient and the vessel remained stable.The pci was performed successfully and the patient remained stable upon recovery and was discharged the same day without concern.
 
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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
Manufacturer (Section G)
BOSTON SCIENTIFIC CORPORATION
ballybrit business park
galway
EI  
Manufacturer Contact
jay johnson
4100 hamline ave n
arden hills, MN 55112
6515810888
MDR Report Key15839915
MDR Text Key304088071
Report Number2124215-2022-48304
Device Sequence Number1
Product Code NWX
Combination Product (y/n)N
Reporter Country CodeUK
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Foreign,Health Professional,Company Representative
Reporter Occupation Other Health Care Professional
Type of Report Initial,Followup,Followup
Report Date 01/06/2023
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? No
Device Operator Health Professional
Device Model Number3852
Device Catalogue Number3852
Device Lot Number0029919543
Was Device Available for Evaluation? Device Returned to Manufacturer
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 11/11/2022
Initial Date FDA Received11/21/2022
Supplement Dates Manufacturer Received12/07/2022
12/16/2022
Supplement Dates FDA Received12/12/2022
01/06/2023
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured08/09/2022
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
Patient Outcome(s) Other;
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