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

Model Number 23375

Device Problems Leak/Splash (1354); Material Rupture (1546)

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

Event Date 09/15/2021

Event Type  malfunction  

Event Description

It was reported that balloon rupture occurred.The target lesion was located in the iliac vein.Following thrombectomy, a non-boston scientific balloon catheter was used to inflate first, then a 14-6/5.8/75 xxl vascular balloon catheter was advanced for another dilation.After a stent was deployed, a 14-6/5.8/75 xxl vascular balloon was used for post dilation; however, contrast agent leakage was noted.The device was removed and a hole was found when pressure was applied.A new 14-6/5.8/75 xxl vascular balloon catheter was used to complete the procedure.There were no patient complications reported and the patient was stable.

Event Description

It was reported that balloon rupture occurred.The target lesion was located in the iliac vein.Following thrombectomy, a non-boston scientific balloon catheter was used to inflate first, then a 14-6/5.8/75 xxl vascular balloon catheter was advanced for another dilation.After a stent was deployed, a 14-6/5.8/75 xxl vascular balloon was used for post dilation; however, contrast agent leakage was noted.The device was removed and a hole was found when pressure was applied.A new 14-6/5.8/75 xxl vascular balloon catheter was used to complete the procedure.There were no patient complications reported and the patient was stable.

Manufacturer Narrative

Device evaluated by mfr.: a xxl/14-6/5.8/75 was returned for analysis.A visual examination identified that the balloon was not folded which indicates that the device was subjected to positive pressure.The returned device was attached to an encore inflation unit.Positive pressure was applied when liquid was observed to be leaking from a balloon pinhole located approximately 15mm proximal of the proximal 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 damage or kinks on the shaft of the device.A visual and microscopic examination of the tip and markerbands identified no damage or any issues that could have contributed to the complaint incident.

• 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 CORPORATION; ballybrit business park; galway ; EI
• Manufacturer Contact: jay johnson ; two scimed place; maple grove, MN 55311 ; 7634942574
• MDR Report Key: 12595934
• MDR Text Key: 275404571
• Report Number: 2134265-2021-12596
• Device Sequence Number: 1
• Product Code: LIT
• UDI-Device Identifier: 08714729190486
• UDI-Public: 08714729190486
• Combination Product (y/n): N
• Reporter Country Code: CH
• PMA/PMN Number: K150303
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative,Distributor
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 11/15/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/08/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 01/05/2023
• Device Model Number: 23375
• Device Catalogue Number: 23375
• Device Lot Number: 0024990262
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/18/2021
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/04/2021
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/06/2020
• 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 Age: 55 YR
• Patient Sex: Female
• Patient Weight: 53 KG