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

Model Number 23375

Device Problem Material Integrity Problem (2978)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 10/11/2022

Event Type  malfunction  

Event Description

Reportable based on device analysis completed on 25-nov-2022.It was reported that balloon damage occurred.The patient presented with may-thurner syndrome and underwent venous angioplasty with intervention.The stenosed target lesion was located in the iliac vein.A 16-2/5.8/75 xxl esophageal balloon catheter was advanced for dilatation.However, during inflation, the balloon kept losing pressure despite disconnecting and reconnecting the indeflator.The procedure was completed with another of same device.No patient complications were reported.However, returned device analysis revealed a balloon pinhole.

Manufacturer Narrative

Device evaluated by mfr: the device was received for analysis.A visual examination identified that the balloon was not folded which indicates that the balloon was subjected to positive pressure.Blood present in balloon which is indicative of a leak.The balloon was attached to an encore inflation device, subjected to positive pressure and liquid was observed to be leaking from a balloon pinhole located 30mm distal of the proximal balloon sleeve.An examination of the balloon material and the tip region identified no issues which could potentially have contributed to this complaint.The rated burst pressure for this device is 5 atmospheres as per xxl specification.A visual and tactile examination identified no kinks or damage to the shaft which may have potentially contributed to the complaint incident.A visual examination identified no issues with the tip of the device that could have contributed to the complaint incident.

• 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 Key: 15912202
• MDR Text Key: 307888667
• Report Number: 2124215-2022-50609
• Device Sequence Number: 1
• Product Code: KNQ
• UDI-Device Identifier: 08714729163039
• UDI-Public: 08714729163039
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 12/03/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/03/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 23375
• Device Catalogue Number: 23375
• Device Lot Number: 0029516787
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/17/2022
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/25/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/02/2022
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1