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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 Problem Material Rupture (1546)
Patient Problems Angina (1710); Embolism (1829); ST Segment Elevation (2059)
Event Date 05/30/2019
Event Type  Injury  
Event Description
It was reported that a balloon rupture had occurred.A percutaneous coronary intervention was being performed on a 90% stenosed lesion 21.1 mm in length with a diameter of 2.9-3.3mm in the left circumflex.A 3.5mm x10mm wolverine coronary cutting balloon was used for pre-dilation of the lesion at eight atmospheres for twenty seconds and a second time at ten atmospheres for twenty seconds.After the two pre-dilations, the 6mm x 3.5mm wolverine coronary cutting balloon was used for twenty seconds at ten atmospheres when it was noticed that contrast was leaking from the proximal end of the balloon.The wolverine was removed from the patient, however, it was noted that the patient's st increased and experienced chest pain thereafter.When checked, slow flow was observed in the left anterior descending artery (lad).Nicorandil was administered to the left coronary artery, but the slow flow issue did not improve.In order to improve the flow in the lad, a guidewire was inserted.When administering the nicorandil in the lad, the flow improved, so treatment of the lesion in the left circumflex continued.A synergy stent was placed, apposition confirmed and the procedure was completed.The physician indicated belief that the slow flow was caused by plaque on the balloon having fallen to the lad side after the balloon rupture occurred.
 
Manufacturer Narrative
Cine/media was returned to the manufacturer.As per cine/media results, advancing difficulties and multiple inflations most likely contributed to shaft rupture.Wolverine shaft rupture likely precipitated transient lad closure by collateral vessel occlusion by spasm or micro-embolization.The incident most likely occurred due to challenging lesion characteristics as the target lesion was observed to be severely occluded, diffusely diseased.Taking into consideration the evaluation conducted at the complaint investigation site and the details of the complaint, this investigation is assigned an investigation conclusion code of adverse event related to patient condition.A complaint with an investigation conclusion code of adverse event related to patient condition indicates that an existing condition or disease is demonstrably responsible for the adverse event and use of the device has neither caused nor otherwise influenced this condition/disease related adverse event.
 
Event Description
It was reported that a balloon rupture had occurred.A percutaneous coronary intervention was being performed on a 90% stenosed lesion 21.1 mm in length with a diameter of 2.9-3.3mm in the left circumflex.A 3.5mm x10mm wolverine coronary cutting balloon was used for pre-dilation of the lesion at eight atmospheres for twenty seconds and a second time at ten atmospheres for twenty seconds.After the two pre-dilations, the 6mm x 3.5mm wolverine coronary cutting balloon was used for twenty seconds at ten atmospheres when it was noticed that contrast was leaking from the proximal end of the balloon.The wolverine was removed from the patient, however, it was noted that the patient's st increased and experienced chest pain thereafter.When checked, slow flow was observed in the left anterior descending artery (lad).Nicorandil was administered to the left coronary artery, but the slow flow issue did not improve.In order to improve the flow in the lad, a guidewire was inserted.When administering the nicorandil in the lad, the flow improved, so treatment of the lesion in the left circumflex continued.A synergy stent was placed, apposition confirmed and the procedure was completed.The physician indicated belief that the slow flow was caused by plaque on the balloon having fallen to the lad side after the balloon rupture occurred.
 
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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 Key8732653
MDR Text Key149129244
Report Number2134265-2019-07090
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 08/01/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received06/25/2019
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model Number3851
Device Catalogue Number3851
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer07/18/2019
Date Manufacturer Received07/11/2019
Patient Sequence Number1
Patient Outcome(s) Required Intervention;
Patient Age78 YR
Patient Weight57
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