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

Model Number 23375

Device Problems Material Rupture (1546); Detachment of Device or Device Component (2907)

Patient Problem Device Embedded In Tissue or Plaque (3165)

Event Date 04/18/2019

Event Type  Injury  

Event Description

It was reported that balloon rupture and tip detachment occurred.The target lesion was located in the cephalic arch.A 12-4/5.8/120mm xxl balloon catheter was advanced for dilation.However, on second inflation at 7 atmospheres, the balloon ruptured.The device was pulled and the distal tip of the balloon sheared off.The physician made a few attempts to locate the balloon fragment, but no filling defects were seen and the balloon fragment was not found.No patient complications were reported and the patient was discharged in good condition.

• Brand Name: XXL VASCULAR
• Type of Device: DILATOR, ESOPHAGEAL
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; two scimed place; maple grove MN 55311
• Manufacturer (Section G): BOSTON SCIENTIFIC IRELAND LIMITED; ballybrit business park; galway ; EI
• Manufacturer Contact: sonali arangil ; two scimed place; maple grove, MN 55311 ; 6515827403
• MDR Report Key: 8598820
• MDR Text Key: 144663569
• Report Number: 2134265-2019-04989
• Device Sequence Number: 1
• Product Code: LIT
• UDI-Device Identifier: 08714729162902
• UDI-Public: 08714729162902
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K150303
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 05/10/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/10/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 01/17/2022
• Device Model Number: 23375
• Device Catalogue Number: 23375
• Device Lot Number: 0023210801
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/19/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/18/2019
• 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
• Patient Outcome(s): Other
• Patient Age: 74 YR