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

Model Number	24674
Medical Device Problem Code	Deflation Problem (1149)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/23/2023
Type of Reportable Event	Malfunction
Event or Problem 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.
Additional 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 or Problem 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
• Common Device Name: 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
• Report Number: 2124215-2023-39919
• Device Sequence Number: 4879914
• Product Code: FGE
• UDI-Device Identifier: 08714729794363
• UDI-Public: 08714729794363
• Combination Product (Y/N): N
• Initial Reporter Country: KS
• PMA/510(K) Number: K103751
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative,Distributor
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 09/11/2023

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: 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
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 07/24/2023
• Supplement Date Received by Manufacturer: 08/22/2023
• Initial Report FDA Received Date: 08/16/2023
• Supplement Report FDA Received Date: 09/11/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/03/2020
• 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 Age: 65 YR
• Patient Sex: Male