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

Model Number 24674

Device Problem Deflation Problem (1149)

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

Event Date 07/23/2023

Event Type  malfunction  

Event Description

It was reported that balloon deflation issue occurred.The target lesion was located in the arteriovenous fistula.A 4.0 x 80, 75cm mustang balloon catheter was advanced for dilatation.However, during the procedure with a saline-contrast ratio of 3:7, it was observed that the balloon was inflated at 17 atmospheres and did not deflate perfectly.The balloon was completely removed in a deflated state through the sheath and the procedure was completed with another of the same device.There were no patient complications reported.

Manufacturer Narrative

Device evaluated by mfr.: mustang 4.0 x 80, 75cm, was received for analysis.A visual examination of the returned device found that the balloon was tightly wrapped.There is no evidence to suggest the balloon had been inflated.An examination of the balloon material identified no issues.A visual examination observed no damage to the tip of the device.A visual and tactile examination found no kinks or damage to the shaft of the device.Both markerbands were undamaged and present in the correct position on the shaft of the device.This concludes the product analysis.

Event Description

It was reported that balloon deflation issue occurred.The target lesion was located in the arteriovenous fistula.A 4.0 x 80, 75cm mustang balloon catheter was advanced for dilatation.However, during the procedure with a saline-contrast ratio of 3:7, it was observed that the balloon was inflated at 17 atmospheres and did not deflate perfectly.The balloon was completely removed in a deflated state through the sheath and the procedure was completed with another of the same device.There were no patient complications reported.

• 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: 17558852
• MDR Text Key: 321805799
• Report Number: 2124215-2023-39919
• Device Sequence Number: 1
• Product Code: FGE
• UDI-Device Identifier: 08714729794363
• UDI-Public: 08714729794363
• Combination Product (y/n): N
• Reporter Country Code: KS
• PMA/PMN Number: K103751
• 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: 09/11/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/16/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 09/03/2023
• Device Model Number: 24674
• Device Catalogue Number: 24674
• Device Lot Number: 0025961184
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/22/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/03/2020
• 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: 65 YR
• Patient Sex: Male