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 3851
Device Problems Inflation Problem (1310); Material Puncture/Hole (1504); Material Integrity Problem (2978)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 01/11/2022
Event Type  malfunction  
Event Description
It was reported that a shaft perforation occurred.This 10mmx3.00mm wolverine cutting balloon was selected for a angioplasty procedure.The balloon was unable to be inflated to nominal pressure, as the unspecified guidewire came out from the shaft of the wolverine close to the balloon portion of the device.The procedure was completed with another of the same device.No patient complications were reported.
 
Event Description
It was reported that a shaft perforation occurred.This 10mmx3.00mm wolverine cutting balloon was selected for a angioplasty procedure.The balloon was unable to be inflated to nominal pressure, as the unspecified guidewire came out from the shaft of the wolverine close to the balloon portion of the device.The procedure was completed with another of the same device.No patient complications were reported.
 
Manufacturer Narrative
Device evaluated by mfr: a 10mm x 3.00mm wolverine cutting balloon was returned for analysis.A visual examination identified that the balloon was not folded which indicates that the balloon was subjected to positive pressure.A microscopic examination of the balloon material and markerbands identified no issues which could potentially have contributed to this complaint.All blades were intact within their pads and fully bonded to the balloon material.A visual, microscopic and tactile examination found no kinks along the hypotube.An examination of the distal extrusion identified bunching of the inner /wire lumen at 2.5cm proximal from the proximal balloon cone.Further examinations noted a perforation in the outer extrusion at 2.7cm proximal from the proximal balloon cone.It is likely that as a result of the bunching in the wire lumen, when an attempt was made by the physician to pass the wire through the bunched lumen, it resulted in the guidewire puncturing out through the inner and outer lumen.During an attempt to inflate the balloon liquid leaked out through the perforated hole in the outer.As a result not possible to inflate balloon.The markerbands and tip and of the device were visually and microscopically examined, and no issues were noted with the device that may have potentially contributed to the complaint incident.
 
Event Description
It was reported that a shaft perforation occurred.This 10mmx3.00mm wolverine cutting balloon was selected for a angioplasty procedure.The balloon was unable to be inflated to nominal pressure, as the unspecified guidewire came out from the shaft of the wolverine close to the balloon portion of the device.The procedure was completed with another of the same device.No patient complications were 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
two scimed place
maple grove MN 55311
Manufacturer (Section G)
BOSTON SCIENTIFIC CORPORATION
ballybrit business park
galway
EI  
Manufacturer Contact
jay johnson
two scimed place
maple grove, MN 55311
7634942574
MDR Report Key13514407
MDR Text Key285545304
Report Number2134265-2022-01482
Device Sequence Number1
Product Code NWX
Combination Product (y/n)N
Reporter Country CodeFR
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,Followup
Report Date 03/22/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received02/11/2022
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Expiration Date07/27/2023
Device Model Number3851
Device Catalogue Number3851
Device Lot Number0027735818
Was Device Available for Evaluation? Device Returned to Manufacturer
Is the Reporter a Health Professional? Yes
Date Manufacturer Received03/14/2022
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured07/27/2021
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
-
-