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 24628
Device Problem Material Rupture (1546)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 11/20/2019
Event Type  malfunction  
Event Description
It was reported that balloon rupture occurred.The target lesion was located in the moderately tortuous cephalic vein.A 5.00mm/2.0cm/50cm peripheral cutting balloon was selected for use.During procedure, it was noted that the balloon ruptured upon third inflation at several atm and was removed without problem.The procedure was completed with another of the same device.No patient complications were reported.
 
Event Description
It was reported that balloon rupture occurred.The target lesion was located in the moderately tortuous cephalic vein.A 5.00mm/2.0cm/50cm peripheral cutting balloon was selected for use.During procedure, it was noted that the balloon ruptured upon third inflation at several atm and was removed without problem.The procedure was completed with another of the same device.No patient complications were reported.It was further reported that the device was simply pulled out from the patient's body.The patient condition was stable post procedure.
 
Event Description
It was reported that balloon rupture occurred.The target lesion was located in the moderately tortuous cephalic vein.A 5.00mm/2.0cm/50cm peripheral cutting balloon was selected for use.During procedure, it was noted that the balloon ruptured upon third inflation at several atm and was removed without problem.The procedure was completed with another of the same device.No patient complications were reported.It was further reported that the device was simply pulled out from the patient's body.The patient condition was stable post procedure.
 
Manufacturer Narrative
G5: premarket updated to k070951.Device evaluated by manufacturer: the device was returned for analysis.The following attributes were considered during analysis: a visual examination identified that the balloon was not folded which indicates that the balloon was subjected to positive pressure.Blood was identified within the balloon and inflation lumen which is evidence of a device leak.The returned device was attached to an encore inflation unit.Positive pressure was applied when liquid was observed to be leaking from a balloon pinhole located approximately 9mm proximal of the distal markerband.An examination of the balloon material and markerbands identified no issues which could potentially have contributed to this complaint.The rated burst pressure for this device is 10 atmospheres.A visual and microscopic examination observed no damage to the tip or blades.All blades were present and fully bonded to the balloon surface.A visual and tactile examination identified no kinks or damage to the shaft of the device.No other issues were identified during the product analysis.
 
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 Key9414141
MDR Text Key175076604
Report Number2134265-2019-14985
Device Sequence Number1
Product Code LIT
Combination Product (y/n)N
PMA/PMN Number
K070951
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,distri
Type of Report Initial,Followup,Followup
Report Date 02/06/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/04/2019
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Expiration Date04/17/2021
Device Model Number24628
Device Catalogue Number24628
Device Lot Number0023662395
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer12/10/2019
Date Manufacturer Received01/14/2020
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Treatment
GUIDEWIRE - FUGA; GUIDEWIRE - FUGA; GUIDEWIRE - FUGA; INFLATION DEVICE - KANEKA; INFLATION DEVICE - KANEKA; INFLATION DEVICE - KANEKA
-
-