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 PERIPHERAL CUTTING BALLOON; 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 PERIPHERAL CUTTING BALLOON; CATHETER, PERCUTANEOUS TRANSLUMINAL CORONARY ANGIOPLASTY (PTCA), CUTTING/SCORING Back to Search Results
Model Number 39345-401510
Device Problem Device Dislodged or Dislocated (2923)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 01/29/2024
Event Type  malfunction  
Event Description
It was reported that the blade was partially lifted.The 100% stenosed target lesion was located in the moderately tortuous and severely calcified superficial femoral artery.A 4.0mm x 15mm wolverine peripheral cutting balloon was selected for use.During the procedure, it was noted that the blade got caught in the calcification when it was removed after inflation.Furthermore, part of the blade was lifted up.The device was completely removed from the patient's body and the procedure was complete.No patient complications and the patient was good post procedure.
 
Manufacturer Narrative
Device evaluated by mfr.: the device was returned for analysis.A visual examination of the returned device identified that the balloon had been inflated.The device was attached to an encore inflation unit and filled the balloon with liquid to facilitate an inspection of the blades.The balloon of the device was visually examined, and no issues were noted.A visual examination was performed on the returned device.It was noted that approximately 5mm of the proximal end of one blade had lifted distally from the balloon material.The remaining 15mm of the blade remained fully bonded to the balloon material.The damage identified is consistent with excessive force being applied when resistance is encountered during the withdrawal of the device through the sheath.All other blades were intact and fully bonded to the balloon material.A visual examination identified damage to the tip of the device.This type of damage is consistent with excessive force being applied when resistance is encountered when crossing a lesion.A visual examination found the guidewire lumen to have accordion damage between the distal markerband and the tip.This type of damage is consistent with rapid withdrawal of the device from the guidewire.A visual and tactile examination found the hypotube to be kinked at more than one location.This type of damage is consistent with excessive force being applied to the device.
 
Event Description
It was reported that the blade was partially lifted.The 100% stenosed target lesion was located in the moderately tortuous and severely calcified superficial femoral artery.A 4.0mm x 15mm wolverine peripheral cutting balloon was selected for use.During the procedure, it was noted that the blade got caught in the calcification when it was removed after inflation.Furthermore, part of the blade was lifted up.The device was completely removed from the patient's body and the procedure was complete.No patient complications and the patient was good post procedure.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand Name
WOLVERINE PERIPHERAL CUTTING BALLOON
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
EI  
Manufacturer Contact
rachel shields
4100 hamline ave n
arden hills, MN 55112
6512422111
MDR Report Key18731014
MDR Text Key336739658
Report Number2124215-2024-08455
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 03/25/2024
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received02/19/2024
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model Number39345-401510
Device Catalogue Number39345-401510
Device Lot Number0032576534
Was Device Available for Evaluation? Device Returned to Manufacturer
Is the Reporter a Health Professional? Yes
Date Manufacturer Received03/04/2024
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured10/05/2023
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
-
-