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 Rupture (1546)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 02/10/2022
Event Type  malfunction  
Event Description
It was reported that the balloon burst and device entrapment occurred.The 90% stenosed target lesion was located in the severely tortuous and moderately calcified right coronary artery.A 6mmx2.50mm wolverine coronary cutting balloon was selected for use.During the procedure, the balloon burst upon second inflation under nominal pressure for 3-5 seconds.Afterwards, the balloon got twined with a non-boston scientific guidewire and was unable to be withdrawn.Both device were removed together.The physician used another of same device to complete the procedure.There were no complications reported and the patient is stable.
 
Manufacturer Narrative
Device evaluated by manufacturer: the device was returned for analysis.A visual and microscopic examination of the balloon found no tears or holes in the balloon material.The returned device was attached to an encore inflation unit and the balloon was inflated.The balloon fully inflated and maintained pressure with no leaks noted.Using the same encore, a vacuum was pulled and the balloon deflated with no resistance noted.The balloon was inflated on two more occasions and the balloon maintained pressure for 30 seconds before a vacuum was pulled.No leaks were noted in the balloon.The encore inflation device was verified before and after use.No damage was observed to any of the blades.All blades were fully bonded onto the balloon.A visual and tactile examination found no issues with the hypotube of this device.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.An examination of wire lumen identified no damage.A 0.014inch size wire was inserted through the wire lumen, prior to attempts to inflate the balloon, with no resistance noted.
 
Event Description
It was reported that the balloon burst and device entrapment occurred.The 90% stenosed target lesion was located in the severely tortuous and moderately calcified right coronary artery.A 6mmx2.50mm wolverine coronary cutting balloon was selected for use.During the procedure, the balloon burst upon second inflation under nominal pressure for 3-5 seconds.Afterwards, the balloon got twined with a non-boston scientific guidewire and was unable to be withdrawn.Both device were removed together.The physician used another of same device to complete the procedure.There were no complications reported and the patient is stable.
 
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
two scimed place
maple grove, MN 55311
7634942574
MDR Report Key13699517
MDR Text Key286935652
Report Number2134265-2022-02397
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,Followup
Report Date 04/20/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received03/08/2022
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 Number3850
Device Catalogue Number3850
Device Lot Number0027738915
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer03/07/2022
Is the Reporter a Health Professional? Yes
Date Manufacturer Received03/31/2022
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
Treatment
EBU3.5 MEDTRONIC.; EBU3.5 MEDTRONIC.
Patient Age80 YR
Patient SexMale
Patient Weight66 KG
-
-