MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION XXL VASCULAR; DILATOR, ESOPHAGEAL

Model Number 23375

Device Problem Material Integrity Problem (2978)

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

Event Date 08/01/2019

Event Type  malfunction  

Event Description

It was reported that a balloon had a hole in it.During a procedure, the xxl vascular 14-4/5.8/75 balloon was reported to have a small hole in it.

Manufacturer Narrative

A visual examination identified that the xxl balloon was not folded which indicated that the balloon was subjected to positive pressure.The returned device was attached to a boston scientific encore inflation unit.Positive pressure was applied when liquid was observed to be leaking from a balloon pinhole located approximately 12mm proximal of the distal 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.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 a balloon had a hole in it.During a procedure, the xxl vascular 14-4/5.8/75 balloon was reported to have a small hole in it.

• Brand Name: XXL VASCULAR
• Type of Device: DILATOR, ESOPHAGEAL
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; two scimed place; maple grove MN 55311
• MDR Report Key: 8932115
• MDR Text Key: 155562306
• Report Number: 2134265-2019-10166
• Device Sequence Number: 1
• Product Code: LIT
• UDI-Device Identifier: 08714729190462
• UDI-Public: 08714729190462
• Combination Product (y/n): N
• PMA/PMN Number: K150303
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 10/16/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/26/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 06/17/2021
• Device Model Number: 23375
• Device Catalogue Number: 23375
• Device Lot Number: 0022265587
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/08/2019
• Date Manufacturer Received: 10/10/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1