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

Model Number	23375
Medical Device Problem Code	Material Rupture (1546)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/16/2022
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that balloon rupture occurred.The target lesion was located in the iliac vein.A 14-4/5.8/75 xxl balloon dilator was advanced for dilatation.However, during inflation before reaching the nominal pressure, the balloon ruptured.The procedure was completed with another of the same device.No patient complications were reported and the patient status was stable.
Event or Problem Description
It was reported that balloon rupture occurred.The target lesion was located in the iliac vein.A 14-4/5.8/75 xxl balloon dilator was advanced for dilatation.However, during inflation before reaching the nominal pressure, the balloon ruptured.The procedure was completed with another of the same device.No patient complications were reported and the patient status was stable.It was further reported that the target lesion was 30% stenosed, moderately tortuous and severely calcified.The balloon ruptured during initial inflation.
Additional Manufacturer Narrative
Device evaluated by mfr: the xxl/14-4/5.8/75 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 13mm distal from the distal markerband.An examination of the balloon material and the tip region identified no issues which could potentially have contributed to this complaint.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.
Event or Problem Description
It was reported that balloon rupture occurred.The target lesion was located in the iliac vein.A 14-4/5.8/75 xxl balloon dilator was advanced for dilatation.However, during inflation before reaching the nominal pressure, the balloon ruptured.The procedure was completed with another of the same device.No patient complications were reported and the patient status was stable.It was further reported that the target lesion was 30% stenosed, moderately tortuous and severely calcified.The balloon ruptured during initial inflation.

• Brand Name: XXL VASCULAR
• Common Device Name: 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 ; two scimed place; maple grove, MN 55311 ; 7634942574
• MDR Report Key: 13368709
• Report Number: 2134265-2022-00787
• Device Sequence Number: 19821550
• Product Code: LIT
• UDI-Device Identifier: 08714729190462
• UDI-Public: 08714729190462
• Combination Product (Y/N): N
• Initial Reporter Country: TW
• PMA/510(K) Number: K150303
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative,Distributor
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 03/09/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 04/12/2024
• Device Model Number: 23375
• Device Catalogue Number: 23375
• Device Lot Number: 0027129803
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/09/2022
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 01/20/2022
• Supplement Date Received by Manufacturer: 01/26/2022; 03/03/2022
• Initial Report FDA Received Date: 01/27/2022
• Supplement Report FDA Received Date: 02/07/2022; 03/09/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/13/2021
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown