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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 Leak/Splash (1354); Material Rupture (1546); Adverse Event Without Identified Device or Use Problem (2993)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 10/25/2023
Event Type  malfunction  
Event Description
It was reported that balloon rupture occurred.The target lesion was located in the mid left anterior descending artery.A 10mmx3.50mm wolverine coronary cutting balloon was selected for use.During the procedure, the balloon ruptured upon initial inflation at 6 atmospheres for 5 seconds.The contrast agent was leaking and coming out from the balloon body.The procedure was completed with another of the same device.No complications were reported, and the patient was stable.
 
Event Description
It was reported that balloon rupture occurred.The target lesion was located in the mid left anterior descending artery.A 10mmx3.50mm wolverine coronary cutting balloon was selected for use.During the procedure, the balloon ruptured upon initial inflation at 6 atmospheres for 5 seconds.The contrast agent was leaking and coming out from the balloon body.The procedure was completed with another of the same device.No complications were reported, and the patient was stable.
 
Manufacturer Narrative
Device evaluated by mfr.: a visual examination of the balloon identified blood within the balloon which is consistent with a leak.Multiple hypotube kinks were noted along the hypotube shaft.Visual examination could not identify any kinks or damages.A detailed microscopic examination of the balloon material identified no tears or pinholes in the balloon.All blades were fully bonded on the balloon and did not exhibit any signs of damage.No issues identified during examination of the extrusion shaft.Tip showed no signs of tip damage.A microscopic examination of the proximal and distal markerbands identified no damage.The device was soaked in the water bath at 37 degrees celsius and was attached to an encore inflation device.An attempt was then made to inflate the balloon to 12atm as per, wolverine instructions for use (ifu) using an inflation aid attached however, pressure was unable to be maintained as inflation liquid was observed leaking from a pinhole that was 2mm proximal from proximal markerband.The encore inflation device was verified before and after the procedure using a druck gauge.
 
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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
300 boston scientific way
marlborough MA 01752
Manufacturer (Section G)
BOSTON SCIENTIFIC CORPORATION
ballybrit business park
galway
EI  
Manufacturer Contact
rachel shields
4100 hamline ave n
arden hills, MN 55112
6512422111
MDR Report Key18155460
MDR Text Key328511547
Report Number2124215-2023-63004
Device Sequence Number1
Product Code NWX
Combination Product (y/n)N
Reporter Country CodeCH
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Other,Foreign,Health Professional,Company Representative,Distributor
Reporter Occupation Physician
Type of Report Initial,Followup
Report Date 12/01/2023
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received11/16/2023
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model Number3851
Device Catalogue Number3851
Device Lot Number0031231463
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer11/09/2023
Is the Reporter a Health Professional? Yes
Date Manufacturer Received11/29/2023
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured03/14/2023
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 Age84 YR
Patient SexFemale
Patient Weight49 KG
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