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

Model Number	24674
Medical Device Problem Code	Material Rupture (1546)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	08/06/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Device was returned for evaluation.A visual examination identified that the balloon was not folded which indicates that the balloon was subjected to positive pressure.A complete balloon circumferential tear was identified located approximately 40mm distal of the proximal balloon bond.The rated burst pressure for this device as per specification is 14 atmospheres.A visual and tactile examination found the shaft of the device to be separated at two locations.The distal separation is located approximately 18mm proximal of the distal balloon bond and the proximal separation is located approximately 5mm distal of the proximal balloon bond.The separated middle section of shaft including both markerbands was not returned for analysis.The separated middle section of shaft including both markerbands was not returned for analysis.A visual examination found the tip of the device to be damaged.
Event or Problem Description
It was reported that balloon rupture occurred, and device fragment remained inside the patient.The 99% stenosed target lesion was located in the moderately tortuous left subclavian artery.A 12.0 x 40, 75cm mustang balloon catheter was advanced for dilatation.During the procedure, the balloon ruptured upon first inflation.The device was removed without any problem, and the procedure was completed with a different device.After confirming the rupture on the balloon part, it appeared that there was no problem.However, there was a concern that there might have been damaged on the balloon part and a part remains inside the patient.There were no complications reported, and the patient was in good condition after the procedure.

• 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: 20152361
• Report Number: 2124215-2024-54570
• Device Sequence Number: 4235708
• Product Code: FGE
• UDI-Device Identifier: 08714729793441
• UDI-Public: 08714729793441
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• 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): 09/05/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: 24674
• Device Catalogue Number: 24674
• Device Lot Number: 0033717648
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/26/2024
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/08/2024
• Initial Report FDA Received Date: 09/05/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/28/2024
• 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
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown