MAUDE Adverse Event Report: BOSTON SCIENTIFIC CRE FIXED WIRE; DILATOR, ESOOPHAGEAL

Model Number M0055837

Device Problem Hole In Material (1293)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 06/09/2016

Event Type  malfunction  

Event Description

There was trouble with inflating the balloon and getting psi to maintain.The device was removed from patient and discovered a hole in tip of balloon.An additional balloon was opened and proceeded without issue.

• Brand Name: CRE FIXED WIRE
• Type of Device: DILATOR, ESOOPHAGEAL
• Manufacturer (Section D): BOSTON SCIENTIFIC; 300 boston scientific way; marlborough, MA 01752
• MDR Report Key: 5821794
• MDR Text Key: 50405052
• Report Number: 5821794
• Device Sequence Number: 1
• Product Code: KNQ
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 07/13/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/26/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: M0055837
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 07/13/2016
• Event Location: Hospital
• Date Report to Manufacturer: 07/13/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1