• 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 Problem Material Rupture (1546)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 11/28/2019
Event Type  malfunction  
Manufacturer Narrative
(b)(6).
 
Event Description
It was reported that balloon rupture occurred.The 99% stenosed target lesion was located in the mildly tortuous and severely calcified left anterior descending artery.A 10mmx2.25mm wolverine coronary cutting balloon monorail was selected for use.During the procedure, the balloon was inflated at 6atm, 9atm respectively.However, the balloon ruptured upon third inflation at 12atm and was retrieved without problem.The procedure was completed with a different device.No patient complications were reported.
 
Manufacturer Narrative
Initial reporter city- (b)(6).
 
Event Description
It was reported that balloon rupture occurred.The 99% stenosed target lesion was located in the mildly tortuous and severely calcified left anterior descending artery.A 10mmx2.25mm wolverine coronary cutting balloon monorail was selected for use.During the procedure, the balloon was inflated at 6atm, 9atm respectively.However, the balloon ruptured upon third inflation at 12atm and was retrieved without problem.The procedure was completed with a different device.No patient complications were reported.It was further reported that although there was resistance during removal, the balloon was just simply removed from the patient's body.The patient was good post procedure.
 
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
MDR Report Key9435104
MDR Text Key175872849
Report Number2134265-2019-15251
Device Sequence Number1
Product Code NWX
Combination Product (y/n)N
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Type of Report Initial,Followup
Report Date 12/11/2019
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 Date01/23/2021
Device Model Number3851
Device Catalogue Number3851
Device Lot Number0023239020
Was Device Available for Evaluation? No
Initial Date Manufacturer Received 11/28/2019
Initial Date FDA Received12/08/2019
Supplement Dates Manufacturer Received11/28/2019
Supplement Dates FDA Received12/11/2019
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
-
-