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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)
Patient Problem No Code Available (3191)
Event Date 12/16/2019
Event Type  Injury  
Manufacturer Narrative
Initial reporter city: (b)(6).
 
Event Description
It was reported that balloon rupture and removal difficulties occurred.The target lesion was located in the mildly tortuous and moderately calcified left anterior descending artery.A 10mmx2.50mm wolverine coronary cutting balloon was advanced and at the first dilation, the balloon ruptured at 5atm.The cutting balloon got stuck and could not be removed.The proximal part of the hub of the shaft was cut, and a non-bsc guide extension catheter was advanced to the part where the device was stuck.The balloon was released and removed together with the extension catheter.The procedure was completed with a different device.There were no patient complications reported.
 
Manufacturer Narrative
E1: initial reporter city: (b)(6).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.Blood was identified inside the balloon which is evidence of a device leak.A leak test could not be carried out due to a separation of the hypotube.The rated burst pressure for this device is 12 atmospheres as per wolverine specification.The markerbands, blades and tip section 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.All blades were present and fully bonded to the balloon material.A visual and tactile examination identified a separation of the hypotube.It was reported that the physician cut the hypotube to remove the manifold of the device.The manifold was not returned for analysis.The hypotube was also found to be severely kinked at more than one location.This type of damage is consistent with excessive force being applied to the device.No other issues were identified during the product analysis.
 
Event Description
It was reported that balloon rupture and removal difficulties occurred.The target lesion was located in the mildly tortuous and moderately calcified left anterior descending artery.A 10mmx2.50mm wolverine coronary cutting balloon was advanced and at the first dilation, the balloon ruptured at 5atm.The cutting balloon got stuck and could not be removed.The proximal part of the hub of the shaft was cut, and a non-bsc guide extension catheter was advanced to the part where the device was stuck.The balloon was released and removed together with the extension catheter.The procedure was completed with a different device.There were no patient complications reported.
 
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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 Key9527217
MDR Text Key173337493
Report Number2134265-2019-16231
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 03/12/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Expiration Date10/06/2021
Device Model Number3851
Device Catalogue Number3851
Device Lot Number0024556808
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer01/14/2020
Initial Date Manufacturer Received 12/16/2019
Initial Date FDA Received12/27/2019
Supplement Dates Manufacturer Received02/20/2020
Supplement Dates FDA Received03/12/2020
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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