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 Break (1069); Difficult to Remove (1528); Adverse Event Without Identified Device or Use Problem (2993)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 04/11/2024
Event Type  malfunction  
Event Description
It was reported that a device difficulty removal and fracture occurred.The stenosed target lesion was located in the left anterior descending artery (lad).A 10mmx2.75mm wolverine coronary cutting balloon was selected for use.During the procedure, the device was attempted to use in left anterior descending artery and had a great resistance when inserting it into the guidewire.They tried to remove the catheter, but extreme resistance was encountered, and the catheter was separated outside the y-connector.The remainder of the device was removed along with the entire guidewire.The procedure was completed with another of the same device.There were no patient complications reported port procedure.
 
Manufacturer Narrative
Initial reporter city: (b)(6).
 
Event Description
It was reported that a device difficulty removal and fracture occurred.The stenosed target lesion was located in the left anterior descending artery (lad).A 10mmx2.75mm wolverine coronary cutting balloon was selected for use.During the procedure, the device was attempted to use in left anterior descending artery and had a great resistance when inserting it into the guidewire.They tried to remove the catheter, but extreme resistance was encountered, and the catheter was separated outside the y-connector.The remainder of the device was removed along with the entire guidewire.The procedure was completed with another of the same device.There were no patient complications reported port procedure.
 
Manufacturer Narrative
E1.Initial reporter city: (b)(6).The device was returned and evaluated by manufacturer.Only approximately 4.4cm in length of the distal end of the device was received, including a section of the distal end of the extrusion, the balloon, markerband and tip, loaded on a guidewire.An examination of the distal extrusion showed the extrusion was severely stretched down onto the guidewire.A microscopic examination of the distal extrusion found that the inner and outer lumens were severely stretched.The inner lumen was pulled distally inside the balloon.As a result of this damage the inner lumen was bunched on either side of the distal markerband.A detailed microscopic examination of the balloon material identified no damages.All blades were fully bonded on the balloon and did not exhibit any signs of damage.A microscopic examination of the tip section found no damages.A microscopic examination of the actual markerbands identified no damages.However, due to the inner lumen being pulled distally inside the balloon, the proximal markerband was positioned towards the distal markerband.The outer diameter of the guidewire was measured to be within specification at 0.014inch.An attempt to remove the distal section of the device from the wire failed as the device section was severely stretched down onto the wire.
 
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 CORPORATION
ballybrit business park
galway
Manufacturer Contact
rachel shields
4100 hamline ave n
arden hills, MN 55112
6512422111
MDR Report Key19176585
MDR Text Key341473129
Report Number2124215-2024-24653
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 Other,Foreign,Health Professional,Company Representative,Distributor
Reporter Occupation Physician
Type of Report Initial,Followup
Report Date 06/03/2024
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 Number3851
Device Catalogue Number3851
Device Lot Number0033467751
Was Device Available for Evaluation? Device Returned to Manufacturer
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 04/11/2024
Initial Date FDA Received04/24/2024
Supplement Dates Manufacturer Received05/22/2024
Supplement Dates FDA Received06/03/2024
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured02/21/2024
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
-
-