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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 3850
Device Problems Break (1069); Failure to Advance (2524)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 10/11/2022
Event Type  malfunction  
Event Description
It was reported that hypotube break occurred.The 90% stenosed target lesion was located in the mildly tortuous and moderately-severely calcified left anterior descending artery.A 6mmx2.50mm wolverine coronary cutting balloon was selected for use.After pre-dilatation of lesion was performed using maverick balloon, the device was advanced, but could not cross near the lesion.When the device was further advanced, it was noted that the hypotube got broke.The device was pulled out from the patient and predilated again with the used of nc balloon.The procedure was completed with another of different device.There were no complications reported.The patient was good and stable post procedure.
 
Event Description
It was reported that hypotube break occurred.The 90% stenosed target lesion was located in the mildly tortuous and moderately-severely calcified left anterior descending artery.A 6mmx2.50mm wolverine coronary cutting balloon was selected for use.After pre-dilatation of lesion was performed using maverick balloon, the device was advanced, but could not cross near the lesion.When the device was further advanced, it was noted that the hypotube got broke.The device was pulled out from the patient and predilated again with the used of nc balloon.The procedure was completed with another of different device.There were no complications reported.The patient was good and stable post procedure.
 
Manufacturer Narrative
Device evaluated by manufacturer: the device was returned for analysis.A visual and microscopic examination identified that the balloon was folded.No damage was observed along the entire balloon.All blades were intact within their pads and fully bonded to the balloon material.The device was received in two sections as a result of a break which occurred in the hypotube shaft.The break was located at 13.7cm distal from the strain relief.The distal section of the hypotube break was kinked at 0.2cm and 0.4cm distal from the break site.A visual and tactile examination of the distal extrusion identified no damage.The markerbands were visually and microscopically examined, and no issues were noted with the device that may have potentially contributed to the complaint incident.An examination of the tip section of the device identified no damage.
 
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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
4100 hamline ave n
arden hills, MN 55112
6515810888
MDR Report Key15685340
MDR Text Key306793299
Report Number2124215-2022-43925
Device Sequence Number1
Product Code NWX
Combination Product (y/n)N
Reporter Country CodeIN
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Foreign,Health Professional,Company Representative
Reporter Occupation Physician
Type of Report Initial,Followup
Report Date 02/07/2023
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received10/27/2022
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Expiration Date04/20/2024
Device Model Number3850
Device Catalogue Number3850
Device Lot Number0029265786
Was Device Available for Evaluation? Device Returned to Manufacturer
Is the Reporter a Health Professional? Yes
Date Manufacturer Received01/27/2023
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured04/21/2022
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
Treatment
BALLOON - MAVERICK; BALLOON - MAVERICK; GUIDE CATHETER - 7F JL; GUIDE CATHETER - 7F JL; GUIDEWIRE - RUNTHROUGH; GUIDEWIRE - RUNTHROUGH
Patient SexFemale
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