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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 Break (1069); Material Deformation (2976)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 11/18/2023
Event Type  malfunction  
Manufacturer Narrative
E1 - initial reporter facility name: (b)(6) hospital, (b)(6) university.E1 - initial reporter address 1: (b)(6).
 
Event Description
It was reported that a catheter shaft fracture occurred.The 80% stenosed target lesion was located in the moderately tortuous and moderately calcified left anterior descending artery.A 10mmx3.00mm wolverine coronary cutting balloon was selected for use.During the procedure, it was noted that the device had a mark of being kinked and it was fractured.The procedure was completed with another of the same device.No patient complications and the patient was stable post procedure.
 
Manufacturer Narrative
E1 - initial reporter facility name: (b)(6); e1 - initial reporter address 1: (b)(6).Device evaluated by mfr.: the device was returned for analysis.A visual and tactile examination of the hypotube shaft identified a break at 91cm distal to the distal end of the strain relief.A hypotube kink was also noted 37.4cm distal to the distal end of the strain relief.A visual and tactile examination of the outer and inner lumen and mid-shaft section found no issues.There was no sign of damage, stretching or lifting of the stent struts.No signs of movement, stent was set between the proximal and distal markerbands.Balloon cones were reviewed, and no issues were noted.Balloon wings were tightly wrapped and evenly folded and were not subjected to positive pressure.A visual and tactile examination of the hypotube shaft identified a break at 91cm distal to the distal end of the strain relief.A hypotube kink was also noted 37.4cm distal to the distal end of the strain relief.Bumper tip showed no signs of distal tip damage.
 
Event Description
It was reported that a catheter shaft fracture occurred.The 80% stenosed target lesion was located in the moderately tortuous and moderately calcified left anterior descending artery.A 10mmx3.00mm wolverine coronary cutting balloon was selected for use.During the procedure, it was noted that the device had a mark of being kinked and it was fractured.The procedure was completed with another of the same device.No patient complications and the patient was stable post 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
300 boston scientific way
marlborough MA 01752
Manufacturer (Section G)
BOSTON SCIENTIFIC IRELAND LIMITED
ballybrit business park
galway
EI  
Manufacturer Contact
rachel shields
4100 hamline ave n
arden hills, MN 55112
6512422111
MDR Report Key18278868
MDR Text Key329915939
Report Number2124215-2023-69170
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 01/19/2024
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/06/2023
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 Number0031795135
Was Device Available for Evaluation? Device Returned to Manufacturer
Is the Reporter a Health Professional? Yes
Date Manufacturer Received01/04/2024
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured06/12/2023
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
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