• 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 - GALWAY 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 - GALWAY XXL¿ ESOPHAGEAL DILATOR, ESOPHAGEAL Back to Search Results
Model Number M001145520
Device Problems Balloon; Difficult to Remove ; Material Rupture; Device Damaged by Another Device; Torn Material
Event Date 06/30/2017
Event Type  Injury  
Manufacturer Narrative

(b)(4). Device evaluated by mfr: it is indicated that the device will not be returned for evaluation. A review of the batch history, historical trending, and similar complaint trending review for the product family will be conducted. If there is any further relevant information from that review, a supplemental medwatch will be filed. (b)(4).

 
Event Description

It was reported that balloon rupture, circumferential tear, and removal difficulties occurred resulting in an unretrieved device fragment. The target lesion was located in the inferior vena cava (ivc). Following implantation of a stent in the ivc a 16-4/5. 8/75 xxl¿ esophageal balloon catheter was advanced for post dilation. Upon inflation, the balloon was caught on the stent and ruptured. When the physician started to pull out the balloon, the balloon began to unravel circumferentially and come off the catheter. The device was advanced a little and pulled back again. The balloon continued to unravel and the physician cut off the tip of the balloon. Snaring was attempted but failed. Two more stents were implanted on both sides of the first stent to trap the stent and the balloon tip. No patient complications were reported.

 
Manufacturer Narrative

Bsc id: (b)(4). Tw: (b)(4).

 
Event Description

It was further reported that three wallstents were implanted without issue prior to the use of the 16-4/5. 8/75 xxl¿ esophageal balloon catheter.

 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand NameXXL¿ ESOPHAGEAL
Type of DeviceDILATOR, ESOPHAGEAL
Manufacturer (Section D)
BOSTON SCIENTIFIC - GALWAY
Manufacturer (Section G)
BOSTON SCIENTIFIC - GALWAY
Manufacturer Contact
sonali arangil
one scimed place
maple grove , MN 55311
7634941700
MDR Report Key6717503
Report Number2134265-2017-07479
Device Sequence Number1
Product CodeKNQ
Report Source Manufacturer
Source Type COMPANY REPRESENTATIVE,HEALTH
Reporter Occupation
Type of Report Initial,Followup
Report Date 06/30/2017
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received07/17/2017
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device EXPIRATION Date09/08/2019
Device MODEL NumberM001145520
Device Catalogue Number14-552
Device LOT Number0019692670
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received07/24/2017
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Date Device Manufactured09/14/2016
Is The Device Single Use? Yes
Is this a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

Patient TREATMENT DATA
Date Received: 07/17/2017 Patient Sequence Number: 1
-
-