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 3850
Device Problems Entrapment of Device (1212); Material Deformation (2976)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 03/15/2023
Event Type  malfunction  
Event Description
It was reported that device entrapment occurred.A 6mmx2.75mm wolverine coronary cutting balloon was selected for use.During the procedure and after use, it was noted that the device was completely stuck with a non-boston scientific guidewire.Consequently, it seems that the shaft was bent during the force had been applied to wolverine.The catheter and the guidewire were removed as one unit and the procedure was completed with another of the same device.No patient complications reported.
 
Event Description
It was reported that device entrapment occurred.A 6mmx2.75mm wolverine coronary cutting balloon was selected for use.During the procedure and after use, it was noted that the device was completely stuck with a non-boston scientific guidewire.Consequently, it seems that the shaft was bent during the force had been applied to wolverine.The catheter and the guidewire were removed as one unit and the procedure was completed with another of the same device.No patient complications reported.
 
Manufacturer Narrative
Device evaluated by manufacturer: the device was returned for analysis.Based on the potential hazards/failure modes identified, the following attributes were examined: a visual examination identified that the balloon was in a deflated state.No issues were noted with the balloon of the device that may have potentially contributed to the complaint incident.The marker bands and blades and tip section of the device were visually and microscopically examined, and no issues were noted with the marker bands, blades or tip of the device that may have potentially contributed to the complaint incident.All blades were present and fully bonded to the balloon material.A visual and tactile examination of the hypotube identified no kinks or damages.The device was received in two sections as a result of a break in the distal extrusion.The break in the wire lumen was located at 7cm proximal from the tip.The distal break section (7cm in length) was severely stretched down and trapped on a section of the guidewire.Using a snap gauge the outer diameter of the returned guidewire was measured to be within specification at 0.0135").The distal outer was severely stretched.No other issues were identified during the product analysis.
 
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
jeff wallner
4100 hamline ave n
arden hills, MN 55112
6515811560
MDR Report Key16629375
MDR Text Key312164980
Report Number2124215-2023-14370
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 04/24/2023
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received03/28/2023
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model Number3850
Device Catalogue Number3850
Device Lot Number0029839188
Was Device Available for Evaluation? Device Returned to Manufacturer
Is the Reporter a Health Professional? Yes
Date Manufacturer Received04/18/2023
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured07/27/2022
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
GUIDEWIRE-RUNTHROUGH ULTRA FLOPPY; GUIDEWIRE-RUNTHROUGH ULTRA FLOPPY
-
-