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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 Problem Material Rupture (1546)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 10/27/2021
Event Type  malfunction  
Event Description
It was reported that the balloon ruptured.A 15mmx2.50mm wolverine coronary cutting balloon was selected for use.During the procedure, it was noted that the balloon ruptured.The balloon was removed from the patient's body without any problem using the normal method and the procedure was completed with a different device.No complications were reported and the patient was in good condition after the procedure.
 
Manufacturer Narrative
The wolverine cb mr, ous 15mmx2.50mm, catheter was returned for analysis.A visual examination identified that the balloon was in a deflated state.The balloon and blade surfaces were found to be stained and blood was present inside the balloon material.The returned device was attached to an encore inflation unit and positive pressure was applied in an attempt to inflate the balloon.Liquid was observed to be leaking from balloon pinhole located in the mid body of the balloon material.An examination of the balloon material and markerbands identified no issues which could potentially have contributed to this complaint.Three blades were present on the balloon surface however, a 1.0 mm portion was found to be missing from the distal end of the proximal blade segment on one blade.A visual and tactile examination found no issues with the hypotube or shaft polymer extrusion of this device.No issues were noted with the tip of the device.A visual and microscopic examination found no issue with the marker bands.
 
Event Description
It was reported that the balloon ruptured.A 15mmx2.50mm wolverine coronary cutting balloon was selected for use.During the procedure, it was noted that the balloon ruptured.The balloon was removed from the patient's body without any problem using the normal method and the procedure was completed with a different device.No complications were reported and the patient was in good condition after the procedure.
 
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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
jay johnson johnson
two scimed place
maple grove, MN 55311
7634942574
MDR Report Key12832254
MDR Text Key280938364
Report Number2134265-2021-14488
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 Foreign,Health Professional,Company Representative,Distributor
Reporter Occupation Physician
Type of Report Initial,Followup
Report Date 12/17/2021
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 Model Number3852
Device Catalogue Number3852
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer11/17/2021
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 10/29/2021
Initial Date FDA Received11/17/2021
Supplement Dates Manufacturer Received12/08/2021
Supplement Dates FDA Received12/17/2021
Was Device Evaluated by Manufacturer? Yes
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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