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

Model Number 24674

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

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

Event Date 02/08/2024

Event Type  malfunction  

Event Description

It was reported that balloon rupture occurred.The 70% stenosed target lesion was located in the mildly tortuous and mildly calcified left subclavian vein.A 12.0 x 40, 75cm mustang balloon was advanced for dilation.However, during the first inflation, the balloon ruptured before reaching the nominal pressure and the contrast agent leaked out.The device was removed without any problem and the procedure was completed with another of the same device.No complications were reported, and the patient was in normal condition post-procedure.

Manufacturer Narrative

Device evaluated by mfr: the complaint device was received for product analysis.A visual examination identified that the balloon was not folded which indicates that the balloon was subjected to positive pressure.A device leak test was performed when liquid was observed exiting a balloon pinhole located at approximately 3mm distal of the proximal markerband.The rated burst pressure for this device as per specification is 14 atmospheres.A visual and tactile examination found no kinks or damage to the shaft of the device.A visual and tactile examination found no damage to the tip of the device.A visual examination observed no issues with the markerbands of the device.Both markerbands were undamaged in the correct position on the device.This concludes the product analysis.

Event Description

It was reported that balloon rupture occurred.The 70% stenosed target lesion was located in the mildly tortuous and mildly calcified left subclavian vein.A 12.0 x 40, 75cm mustang balloon was advanced for dilation.However, during the first inflation, the balloon ruptured before reaching the nominal pressure and the contrast agent leaked out.The device was removed without any problem and the procedure was completed with another of the same device.No complications were reported, and the patient was in normal condition post-procedure.

• 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: 18784653
• MDR Text Key: 336341305
• Report Number: 2124215-2024-11135
• Device Sequence Number: 1
• Product Code: FGE
• UDI-Device Identifier: 08714729793441
• UDI-Public: 08714729793441
• Combination Product (y/n): N
• Reporter Country Code: KS
• 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,Distributor
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 04/12/2024

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
• Device Operator: Health Professional
• Device Model Number: 24674
• Device Catalogue Number: 24674
• Device Lot Number: 0032242125
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 02/13/2024
• Initial Date FDA Received: 02/26/2024
• Supplement Dates Manufacturer Received: 04/02/2024
• Supplement Dates FDA Received: 04/12/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/18/2023
• 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
• Patient Age: 81 YR
• Patient Sex: Male