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

Model Number 24674

Device Problems Material Integrity Problem (2978); Failure to Deflate (4060)

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

Event Date 07/22/2023

Event Type  malfunction  

Event Description

It was reported that deflation issue occurred.The 80% stenosed target lesion was located in the mildly tortuous and mildly calcified arteriovenous fistula.A 9.0 x 40, 75cm mustang balloon catheter was advanced for dilation.However, during the procedure, the balloon was inflated until 17 atmospheres using a non-boston scientific (bsc) device with a ratio of three to seven; however, when used for re-insertion, the balloon did not fully deflate and was noted to be damaged.The physician deflated the balloon first and removed through a sheath, and eventually, the balloon was removed as normal at around 1 minute in a deflated state.The procedure was completed with this device and no patient complications were reported.

Manufacturer Narrative

E1: initial reporter phone: (b)(6).

• 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; ballybrit business park; galway ; EI
• Manufacturer Contact: rachel shields ; 4100 hamline ave n; arden hills, MN 55112 ; 6512422111
• MDR Report Key: 17568824
• MDR Text Key: 321557582
• Report Number: 2124215-2023-39839
• Device Sequence Number: 1
• Product Code: FGE
• UDI-Device Identifier: 08714729793489
• UDI-Public: 08714729793489
• 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
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 08/17/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/17/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 02/08/2024
• Device Model Number: 24674
• Device Catalogue Number: 24674
• Device Lot Number: 0026772595
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 07/23/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/08/2021
• 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: 57 YR
• Patient Sex: Female