MAUDE Adverse Event Report: BOSTON SCIENTIFIC BALLOON DILATION CATHETER SZ 18; CRE ESOPHAGEAL BALLOON CATHETER

Lot Number 90504745-06

Device Problems Deflation Problem (1149); Inflation Problem (1310); Device Operates Differently Than Expected (2913); Material Deformation (2976)

Patient Problem Injury (2348)

Event Date 07/27/2016

Event Type  Injury  

Event Description

Procedure: egd with dilation.Problem: cre balloon had a crimp in the line that prevented full inflation of the balloon and also prevented deflation of the balloon.This resulted in a scraping error of the esophagus upon removal of the balloon.Reason for use: esophageal strictures.

• Brand Name: BALLOON DILATION CATHETER SZ 18
• Type of Device: CRE ESOPHAGEAL BALLOON CATHETER
• Manufacturer (Section D): BOSTON SCIENTIFIC; marlborough MA 01752
• MDR Report Key: 5865330
• MDR Text Key: 51874658
• Report Number: MW5063965
• Device Sequence Number: 1
• Product Code: KNQ
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 08/05/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/05/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Lot Number: 90504745-06
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 62 YR
• Patient Weight: 49