Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • Decrease font size
  • Return font size to normal
  • Increase font size
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
  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

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 Break (1069)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 11/06/2023
Event Type  malfunction  
Event Description
It was reported that a device fracture occurred.The 80% stenosed target lesion was located in the diffuse and severely calcified artery.A 15mmx3.00mm wolverine coronary cutting balloon was selected for use.While trying to cross the lesion, the physician attempted to push the device through with resistance and the shaft snapped near the hub.The fractured device was pulled out from the body and the procedure was completed successfully.There were no patient complications reported.
 
Event Description
It was reported that a device fracture occurred.The 80% stenosed target lesion was located in the diffuse and severely calcified artery.A 15mmx3.00mm wolverine coronary cutting balloon was selected for use.While trying to cross the lesion, the physician attempted to push the device through with resistance and the shaft snapped near the hub.The fractured device was pulled out from the body and the procedure was completed successfully.There were no patient complications reported.
 
Manufacturer Narrative
H6 evaluation conclusion codes: corrected.Device evaluated by manufacturer: the device was returned for analysis.A visual, tactile, and microscopic analysis were performed on the device.A visual examination of the balloon identified no damages.A hypotube break was noted at 21cm distal to the distal end of the strain relief.There were no signs of tip damage.No kinks or damages were noted on the shaft polymer extrusion.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.A microscopic examination of the proximal and distal markerbands identified no damage.
 
Event Description
It was reported that a device fracture occurred.The 80% stenosed target lesion was located in the diffuse and severely calcified artery.A 15mmx3.00mm wolverine coronary cutting balloon was selected for use.While trying to cross the lesion, the physician attempted to push the device through with resistance and the shaft snapped near the hub.The fractured device was pulled out from the body and the procedure was completed successfully.There were no patient complications reported.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

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 Key18179407
MDR Text Key328629287
Report Number2124215-2023-65481
Device Sequence Number1
Product Code NWX
Combination Product (y/n)N
Reporter Country CodeSF
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Other,Foreign,Health Professional,Company Representative
Reporter Occupation Physician
Type of Report Initial,Followup,Followup
Report Date 01/24/2024
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
Device Lot Number0031314667
Was Device Available for Evaluation? Device Returned to Manufacturer
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 11/21/2023
Initial Date FDA Received11/20/2023
Supplement Dates Manufacturer Received11/21/2023
01/17/2024
Supplement Dates FDA Received11/21/2023
01/24/2024
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured03/27/2023
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
-
-