• 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 Difficult to Advance (2920); Material Deformation (2976)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 04/14/2022
Event Type  malfunction  
Manufacturer Narrative
Device evaluated by manufacturer: the device was returned for analysis without the distal shaft containing the balloon with blades, tip, and the inner/outer shaft polymer extrusions.A visual examination on the balloon, blades, pads, tip, marker band and shaft polymer extrusion could not be performed as this section of the device was not returned.A visual and tactile examination was completed on the shaft of the device and multiple hypotube kinks were noted.Additionally, a complete hypotube break at 68 cm distal from the strain relief was noted.
 
Event Description
Reportable based on device analysis completed on (b)(6) 2022.It was reported that the delivery shaft got kinked.The 11mm x 2.5mm in diameter, 92% stenosed target lesion was located in the moderately tortuous and moderately calcified left anterior descending artery.A 10mmx2.50mm wolverine coronary cutting balloon was selected for use.During the procedure, upon advancing, a resistance was felt, and delivery shaft kinked was noted.The device was removed intact.The procedure was completed with a different device.No complications were reported, and patient was stable post procedure.However, device analysis revealed that the hypotube was completely broke 68cm distal from the strain relief.
 
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 IRELAND LIMITED
ballybrit business park
galway
EI  
Manufacturer Contact
jay johnson
4100 hamline ave n
arden hills, MN 55112
6515810888
MDR Report Key15402870
MDR Text Key304537904
Report Number2124215-2022-33363
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 Foreign,Health Professional,Company Representative,Distributor
Reporter Occupation Physician
Type of Report Initial
Report Date 09/12/2022
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 Expiration Date12/06/2023
Device Model Number3851
Device Catalogue Number3851
Device Lot Number0028503034
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer07/20/2022
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 08/18/2022
Initial Date FDA Received09/12/2022
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured12/06/2021
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
Patient Age66 YR
Patient SexMale
Patient Weight83 KG
-
-