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

Model Number	24674
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/26/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Device evaluated by mfr.: device was returned for analysis and underwent a visual and tactile examination.The balloon was not folded which indicates that the balloon was subjected to positive pressure.A balloon pinhole was noted, located approximately at the proximal markerband.The rated burst pressure for this device as per hub is 20 atmospheres.No kinks or damages were noted on the shaft and 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.
Event or Problem Description
Reportable based on the device analysis completed on 30may2024.It was reported that balloon leak occurred.The target lesion was located in the coronary vein, and the patient underwent a transjugular portal shunt.An 8.0 x 60, 135cm mustang balloon catheter was advanced to dilate a non-boston scientific stent.During the procedure, indirect portal vein angiography was conducted to visualize the relationship between the portal vein and the liver vein.Direct portal vein angiography revealed that the main portal vein was unobstructed, though the gastric coronary vein appeared thickened and sluggish.Portal pressure was recorded at 37 mmhg.However, upon inflation, the balloon leaked, and pressure could not be maintained even after the balloon was removed from the patient.The device was replaced for another of the same model to complete the procedure.No complications reported, and patient status was stable.However, device returned analysis revealed a pinhole.

• 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; 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: 19587909
• Report Number: 2124215-2024-37941
• Device Sequence Number: 3506072
• Product Code: FGE
• UDI-Device Identifier: 08714729794714
• UDI-Public: 08714729794714
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K141521
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Health Professional,Company Representative,Distributor
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 06/21/2024

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
• Operator of Device: Health Professional
• Device Expiration Date: 01/29/2026
• Device Model Number: 24674
• Device Catalogue Number: 24674
• Device Lot Number: 0030944163
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/22/2024
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/30/2024
• Initial Report FDA Received Date: 06/21/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/30/2023
• 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: 74 YR
• Patient Sex: Male
• Patient Weight: 86 KG