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 2CM PERIPHERAL CUTTING BALLOON; CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINA
  • 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 2CM PERIPHERAL CUTTING BALLOON; CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINA Back to Search Results
Model Number 24630
Device Problems Detachment of Device or Device Component (2907); Difficult to Advance (2920); Device Dislodged or Dislocated (2923)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 05/14/2021
Event Type  malfunction  
Event Description
It was reported that a blade detachment occurred.The 70% stenosed target lesion was located in the non tortuous and non calcified brachial vein.A 5.00mm/2.0cm/90cm peripheral cutting balloon was selected for use.During the procedure, resistance was felt when the catheter was tried to insert into the sheath.The device was removed via the sheath and it was noted that one of the blades was detached.The procedure was completed with another of same device.No patient complications were reported and patient was stable post procedure.
 
Manufacturer Narrative
Device evaluated by mfr: the device was returned for evaluation.A visual examination of the returned device identified that the balloon had been inflated and was not refolded.It is not known when the balloon was subjected to positive pressure.The balloon of the device was visually and microscopically examined, and no issues were noted that may have potentially contributed to the complaint incident.A visual examination of the returned device identified that 8mm blade and pad lift were noted to have lifted on one of the blades.All blades were present and fully bonded to the balloon surface.No issues were noted with the tip section of the device.A visual and microscopic examination found no issue with the markerbands.A visual and tactile examination identified no kinks or damage to the shaft of the returned device.No other issues were identified during the product analysis.
 
Event Description
It was reported that a blade detachment occurred.The 70% stenosed target lesion was located in the non tortuous and non calcified brachial vein.A 5.00mm/2.0cm/90cm peripheral cutting balloon was selected for use.During the procedure, resistance was felt when the catheter was tried to insert into the sheath.The device was removed via the sheath and it was noted that one of the blades was detached.The procedure was completed with another of same device.No patient complications were reported and patient was stable post procedure.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand Name
2CM PERIPHERAL CUTTING BALLOON
Type of Device
CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINA
Manufacturer (Section D)
BOSTON SCIENTIFIC CORPORATION
two scimed place
maple grove MN 55311
MDR Report Key12168030
MDR Text Key261537804
Report Number2134265-2021-08721
Device Sequence Number1
Product Code LIT
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 08/05/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received07/14/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Expiration Date11/05/2022
Device Model Number24630
Device Catalogue Number24630
Device Lot Number0026311117
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer07/12/2021
Date Manufacturer Received07/30/2021
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
-
-