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 Material Rupture (1546); Detachment of Device or Device Component (2907)
Patient Problem Device Embedded In Tissue or Plaque (3165)
Event Date 03/26/2020
Event Type  Injury  
Manufacturer Narrative
(b)(6).
 
Event Description
It was reported that a balloon rupture occurred and a portion of the blade was left inside the patient.The 90% stenosed target lesion was located in the moderately tortuous and severely napkin-ring like calcified artery.A 10mmx3.00mm wolverine coronary cutting balloon was selected for use.During the procedure, the physician decided to apply high pressure and lesion was dilated at 24atm; however, it was noted that the balloon was inflated beyond the rated pressure and ruptured at that moment.Furthermore, the balloon was stuck in the lesion and it was suspected that the distal site of the blade was stuck in the calcification.Consequently, the balloon was removed using a guide extension catheter.When the device was checked outside patient's body, it was noted that the tip part of one blade out of three was missing.Ivus was then performed and the detached portion was seen immersed/floating in the lesion area.Thus, the detached portion was covered with a stent.No further patient complications were reported and the patient was good post procedure.
 
Manufacturer Narrative
Initial reporter city: (b)(6).The device was returned for evaluation.A visual and microscopic examination was performed on the returned device.It was noted that a section of one of the blades, approximately 5mm in length was completely detached from the distal end of the blade.The remaining section of blade was undamaged and fully bonded to the balloon material.The complete pad of the blade remained fully bonded to the balloon material.The detached section of blade was not returned for analysis.The damage identified can potentially be a result of the resistance encountered during use of the device.All other blades were intact and fully bonded to the balloon material.A visual examination identified that the balloon was not folded which indicates that the balloon was subjected to positive pressure.A microscopic examination identified a balloon longitudinal tear beginning approximately 1mm proximal of the distal tip and extending approximately 8mm across the balloon material.An examination of the balloon material and markerbands identified no issues which could potentially have contributed to this complaint.A visual and tactile examination found no kinks or damage to the hypotube of the device.A visual examination identified no damage to the tip of the device.No other issues were identified during the product analysis.
 
Event Description
It was reported that a balloon rupture occurred and a portion of the blade was left inside the patient.The 90% stenosed target lesion was located in the moderately tortuous and severely napkin-ring like calcified artery.A 10mmx3.00mm wolverine coronary cutting balloon was selected for use.During the procedure, the physician decided to apply high pressure and lesion was dilated at 24atm; however, it was noted that the balloon was inflated beyond the rated pressure and ruptured at that moment.Furthermore, the balloon was stuck in the lesion and it was suspected that the distal site of the blade was stuck in the calcification.Consequently, the balloon was removed using a guide extension catheter.When the device was checked outside patient's body, it was noted that the tip part of one blade out of three was missing.Ivus was then performed and the detached portion was seen immersed/floating in the lesion area.Thus, the detached portion was covered with a stent.No further patient complications were reported and 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 Key9973886
MDR Text Key188207554
Report Number2134265-2020-04814
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,distri
Type of Report Initial,Followup
Report Date 06/01/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received04/17/2020
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Expiration Date12/19/2021
Device Model Number3851
Device Catalogue Number3851
Device Lot Number0024962709
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer04/15/2020
Date Manufacturer Received05/05/2020
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Outcome(s) Required Intervention;
-
-