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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 Inflation Problem (1310); Material Integrity Problem (2978)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 11/21/2018
Event Type  malfunction  
Manufacturer Narrative
Age at time of event: 18 years or older.A visual examination identified that the balloon was not folded which indicates that the balloon was subjected to positive pressure.Blood was identified within the balloon which is evidence of a device leak.The returned device was attached to an encore inflation unit and positive pressure was applied in an attempt to inflate the balloon using glycerol/water.The balloon could not be inflated due to the presence of solidified blood that was present within the inflation lumen.The device was soaked in a water bath at a temperature of 37 degrees celsius to help soften the blood before further inflation attempts were made.The device was removed from the bath and the balloon was again attached to an inflation device subjected to positive pressure using glycerol/water but the device still could not be inflated.A microscopic examination identified a balloon pinhole located approximately 1mm proximal of the proximal markerband.An examination of the balloon material and proximal markerband identified no issues which could potentially have contributed to this complaint.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 no issues with the shaft of the device which potentially have contributed to the complaint incident.No other issues were identified during the product analysis.
 
Event Description
Reportable based on the product analysis completed on january 7, 2019.It was reported that failure to inflate a balloon and balloon damage occurred.A 10mm x 2.75 wolverine coronary cutting balloon monorail was advanced to the target lesion, and backflow of blood into the indeflator occurred.The cutting balloon was suspected to be damaged, and since it did not inflate, it was pulled out.There was no resistance upon crossing, and it did not inflate even once.The procedure was completed with a non bsc device successfully.No patient complications were reported in relation to this event.However, device analysis revealed a pinhole in the balloon material.
 
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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 IRELAND LIMITED
ballybrit business park
galway
EI  
Manufacturer Contact
sonali arangil
two scimed place
maple grove, MN 55311
6515827403
MDR Report Key8289709
MDR Text Key134498892
Report Number2134265-2019-00299
Device Sequence Number1
Product Code NWX
Combination Product (y/n)N
Reporter Country CodeJA
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,distri
Reporter Occupation Physician
Type of Report Initial
Report Date 01/30/2019
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 Date09/30/2020
Device Model Number3851
Device Catalogue Number3851
Device Lot Number0022727775
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer12/11/2018
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 01/07/2019
Initial Date FDA Received01/30/2019
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured10/01/2018
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
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