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 XXL VASCULAR; DILATOR, ESOPHAGEAL
  • 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 XXL VASCULAR; DILATOR, ESOPHAGEAL Back to Search Results
Model Number 23375
Device Problem Material Rupture (1546)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 11/06/2019
Event Type  malfunction  
Event Description
It was reported that balloon rupture occurred.Vascular access was obtained via the femoral artery.The 60% stenosed target lesion was located in the mildly tortuous and mildly calcified arteriovenous fistula.A 14-6/5.8/75 xxl balloon catheter was advanced for dilatation.However, during first inflation at 8 atmospheres for 30 seconds, the balloon ruptured.The procedure was completed with another of the same device.No patient complications were reported and the patient's status was stable.
 
Manufacturer Narrative
Device evaluated by mfr.: the device was returned for analysis.A visual examination identified that the balloon was not folded which indicates that the balloon was subjected to positive pressure.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 distal to the distal end of the proximal markerband.An examination of the balloon material and markerbands identified no issues which could potentially have contributed to this complaint.A visual and tactile examination identified no issues with the tip of the device that could have contributed to the complaint incident.No damage or kinks were identified on the shaft of the device.No other issues were identified during the product analysis.
 
Event Description
It was reported that balloon rupture occurred.Vascular access was obtained via the femoral artery.The 60% stenosed target lesion was located in the mildly tortuous and mildly calcified arteriovenous fistula.A 14-6/5.8/75 xxl balloon catheter was advanced for dilatation.However, during first inflation at 8 atmospheres for 30 seconds, the balloon ruptured.The procedure was completed with another of the same device.No patient complications were reported and the patient's status was stable.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand Name
XXL VASCULAR
Type of Device
DILATOR, ESOPHAGEAL
Manufacturer (Section D)
BOSTON SCIENTIFIC CORPORATION
two scimed place
maple grove MN 55311
MDR Report Key9372576
MDR Text Key173945546
Report Number2134265-2019-14447
Device Sequence Number1
Product Code LIT
UDI-Device Identifier08714729190486
UDI-Public08714729190486
Combination Product (y/n)N
PMA/PMN Number
K150303
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,distri
Type of Report Initial,Followup
Report Date 02/04/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received11/25/2019
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Expiration Date05/15/2022
Device Model Number23375
Device Catalogue Number23375
Device Lot Number0023805021
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer12/16/2019
Date Manufacturer Received01/17/2020
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Age55 YR
Patient Weight60
-
-