• 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 ESOPHAGEAL; 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 ESOPHAGEAL; DILATOR, ESOPHAGEAL Back to Search Results
Model Number 23375
Device Problem Material Rupture (1546)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 06/15/2022
Event Type  malfunction  
Event Description
It was reported that balloon rupture occurred.The stenosed target lesion was located in the pulmonary artery.A 18-4/5.8/120 xxl esophageal balloon dilator was advanced for dilatation.The balloon was inflated at which the normal pressure of the device did not reach 5 atmospheres.However, the balloon exploded and no more pressure was applied to the balloon.The procedure was completed with another device.There were no patient complications reported and the patient status was fine.
 
Event Description
It was reported that balloon rupture occurred.The stenosed target lesion was located in the pulmonary artery.A 18-4/5.8/120 xxl esophageal balloon dilator was advanced for dilatation.The balloon was inflated at which the normal pressure of the device did not reach 5 atmospheres.However, the balloon exploded and no more pressure was applied to the balloon.The procedure was completed with another device.There were no patient complications reported and the patient status was fine.It was further reported that the target lesion was moderately calcified with mild stenosis.The balloon was inflated two times, however, on the second inflation at 4 atmospheres, the balloon ruptured.The balloon was well removed and no residues left on the patient's body.
 
Event Description
It was reported that balloon rupture occurred.The stenosed target lesion was located in the pulmonary artery.A 18-4/5.8/120 xxl esophageal balloon dilator was advanced for dilatation.The balloon was inflated at which the normal pressure of the device did not reach 5 atmospheres.However, the balloon exploded and no more pressure was applied to the balloon.The procedure was completed with another device.There were no patient complications reported and the patient status was fine.It was further reported that the target lesion was moderately calcified with mild stenosis.The balloon was inflated two times, however, on the second inflation at 4 atmospheres, the balloon ruptured.The balloon was well removed and no residues left on the patient's body.
 
Manufacturer Narrative
Device evaluated by mfr.: xxl/18-4/5.8/120 was received for analysis.A visual examination identified that the balloon was not folded which indicates that the device was subjected to positive pressure.Blood was identified within the balloon which is evidence of a device leak.A balloon partial circumferential tear was identified located approximately 15mm distal 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 damage or kinks on the shaft of the device.A visual examination of the tip and markerbands identified no damage or any issues that could have contributed to the complaint incident.This concludes the product analysis.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand Name
XXL ESOPHAGEAL
Type of Device
DILATOR, ESOPHAGEAL
Manufacturer (Section D)
BOSTON SCIENTIFIC CORPORATION
two scimed place
maple grove MN 55311
Manufacturer (Section G)
BOSTON SCIENTIFIC CORPORATION
ballybrit business park
galway
EI  
Manufacturer Contact
jay johnson
4100 hamline ave n
arden hills, MN 55112
6515810888
MDR Report Key14757980
MDR Text Key298169292
Report Number2134265-2022-07121
Device Sequence Number1
Product Code KNQ
UDI-Device Identifier08714729163176
UDI-Public08714729163176
Combination Product (y/n)N
Reporter Country CodeKS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Foreign,Health Professional,Company Representative,Distributor
Reporter Occupation Physician
Type of Report Initial,Followup,Followup
Report Date 08/19/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received06/21/2022
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model Number23375
Device Catalogue Number23375
Device Lot Number0028385466
Was Device Available for Evaluation? Device Returned to Manufacturer
Is the Reporter a Health Professional? Yes
Date Manufacturer Received08/18/2022
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured11/15/2021
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
-
-