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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 Problem Material Puncture/Hole (1504)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 01/26/2021
Event Type  malfunction  
Manufacturer Narrative
(b)(6).
 
Event Description
It was reported that a shaft rupture occurred.A 10mm x 3.50mm wolverine cutting balloon was used for treatment, but a hypotube rupture occurred.The procedure was completed and no patient complications were reported in relation to this event.The patient was reported to be well and stable after the procedure.
 
Manufacturer Narrative
E1- initial reporter phone:(b)(6).
 
Event Description
It was reported that a shaft ruptured.A 10mm x 3.50mm wolverine cutting balloon was used for treatment, but a hypotube rupture occurred.The procedure was completed and no patient complications were reported in relation to this event.The patient was reported to be well and stable after the procedure.It was further reported that the 70% stenosed target lesion was located in the mildly calcified left anterior descending artery (lad).The hypotube ruptured while inserting the device in the introducer.The rupture was noticed while outside the patient.The procedure was successfully completed.No patient complications resulted in relation to this event and the patient was reported to be stable following the procedure.
 
Event Description
It was reported that a shaft ruptured.A 10mm x 3.50mm wolverine cutting balloon was used for treatment, but a hypotube rupture occurred.The procedure was completed and no patient complications were reported in relation to this event.The patient was reported to be well and stable after the procedure.It was further reported that the 70% stenosed target lesion was located in the mildly calcified left anterior descending artery (lad).The hypotube ruptured while inserting the device in the introducer.The rupture was noticed while outside the patient.The procedure was successfully completed.No patient complications resulted in relation to this event and the patient was reported to be stable following the procedure.
 
Manufacturer Narrative
E1- initial reporter phone: (b)(6).Device evaluated by mfr: a 10mm x 3.50mm wolverine cutting balloon was returned for analysis.A visual examination identified that the balloon wings were found to tightly wrapped and had not been subjected to positive pressure.There were no issues noted with the balloon material.All blades were securely bonded and no damage to the blades were noted.No issues were noted with the tip section of the device.A visual and microscopic examination found no issue with the marker bands.A visual and tactile examination was completed on the shaft of the device.A hypotube break was identified at 90.8 cm distally from the strain relief.Multiple hypotube kinks were also present of the device.
 
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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 Key11271939
MDR Text Key230047698
Report Number2134265-2021-01138
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,foreig
Type of Report Initial,Followup,Followup
Report Date 03/19/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received02/03/2021
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 Number0024556804
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer02/16/2021
Date Manufacturer Received03/12/2021
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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