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	10/24/2023
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that balloon rupture occurred.The 90% stenosed target lesion was located in the mildly tortuous and moderately calcified central vein.A 14-4/5.8/75 xxl balloon catheter was advanced for dilatation.However, during the initial inflation at 4 bar, the balloon ruptured.The device was removed, and the procedure was completed with another of same device.There were no complications reported and the patient condition was stable post-procedure.
Additional Manufacturer Narrative
E1 - initial reporter address 1: (b)(6).
Event or Problem Description
It was reported that balloon rupture occurred.The 90% stenosed target lesion was located in the mildly tortuous and moderately calcified central vein.A 14-4/5.8/75 xxl balloon catheter was advanced for dilatation.However, during the initial inflation at 4 bar, the balloon ruptured.The device was removed, and the procedure was completed with another of same device.There were no complications reported and the patient condition was stable post-procedure.
Additional Manufacturer Narrative
E1 - initial reporter address 1: (b)(6).Device evaluated by mfr: 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.A balloon pinhole was also identified located approximately 5mm distal of the proximal markerband.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 of the device.A visual examination identified no issues with the tip of the device.

• Brand Name: XXL VASCULAR
• Common Device Name: DILATOR, ESOPHAGEAL
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 300 boston scientific way; marlborough MA 01752
• Manufacturer (Section G): BOSTON SCIENTIFIC CORPORATION; ballybrit business park; galway ; EI
• Manufacturer Contact: rachel shields ; 4100 hamline ave n; arden hills, MN 55112 ; 6512422111
• MDR Report Key: 18072727
• Report Number: 2124215-2023-61929
• Device Sequence Number: 7665734
• 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: Other,Foreign,Health Professional,Company Representative,Distributor
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 11/27/2023

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: 01/29/2026
• Device Model Number: 23375
• Device Catalogue Number: 23375
• Device Lot Number: 0030951101
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 10/27/2023
• Supplement Date Received by Manufacturer: 11/23/2023
• Initial Report FDA Received Date: 11/06/2023
• Supplement Report FDA Received Date: 11/27/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/30/2023
• 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