MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION MUSTANG; CATHETER, BILIARY, DIAGNOSTIC

Model Number 24674

Device Problem Material Rupture (1546)

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

Event Date 03/04/2024

Event Type  malfunction  

Event Description

It was reported that balloon rupture occurred.The patient underwent a vascular balloon dilatation.The 90% stenosed target lesion was located in the moderately tortuous shunt blood vessel.A 5.0 x 40, 75cm mustang balloon catheter was advanced for dilation.During the procedure, the balloon ruptured on the first inflation at 4 atmospheres for 30 seconds.The device was removed without any problem and replaced for a different model to complete the procedure.There were no patient complications reported.

Manufacturer Narrative

Device evaluated by mfr.: mustang device was returned and attached to an encore inflation unit.Visual examination identified that the balloon was not folded which indicates that the balloon was subjected to positive pressure.Positive pressure was applied when deionized water (di) was observed to be leaking from a balloon pinhole located approximately 5mm proximal from the proximal markerband.Markerband had no visual issues noted.Shaft and tip underwent a visual and tactile examination in which no kinks or damage were identified.

• Brand Name: MUSTANG
• Type of Device: CATHETER, BILIARY, DIAGNOSTIC
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 300 boston scientific way; marlborough MA 01752
• Manufacturer (Section G): BOSTON SCIENTIFIC CORPORATION; pmt 741 persiaran cassia selat; bandarcassia, pulau pinan 14110 ; MY 14110
• Manufacturer Contact: rachel shields ; 4100 hamline ave n; arden hills, MN 55112 ; 6512422111
• MDR Report Key: 18988258
• MDR Text Key: 338729813
• Report Number: 2124215-2024-18560
• Device Sequence Number: 1
• Product Code: FGE
• UDI-Device Identifier: 08714729793366
• UDI-Public: 08714729793366
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K141521
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 03/27/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/27/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 24674
• Device Catalogue Number: 24674
• Device Lot Number: 0032612211
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/19/2024
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/07/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/13/2023
• 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
• Treatment: RADIFOCUS 0.035; ULTRA HIGH FLOW 5F