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

Model Number	24673
Medical Device Problem Codes	Material Rupture (1546); Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/08/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that balloon burst occurred.The 70% stenosed target lesion was located in the mildly tortuous and non-calcified radial arteriovenous fistula.A mustang 7.0 x 200, 75cm balloon catheter was advanced for dilation.During the procedure, the balloon burst while blowing it inside the patient's body upon second inflation at over 10 atmospheres.The procedure was completed with another of the same device.No complications were reported, and the patient was stable.
Additional Manufacturer Narrative
Device evaluated by mfr.: the device was lodged inside the non-boston scientific (bsc) sheath.The recommended introducer/guide sheath size for this device as per specification is minimum of 5fr.It is not possible to determine the size of the bsc sheath and found damaged and incomplete.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 150mm distal of the proximal markerband.As the distal section of balloon material had been pulled distal over the tip of the device.The rated burst pressure for this device as per specification is 18 atmospheres.A visual and tactile examination found the shaft of the device to be severely stretched between the proximal and distal markerbands.A visual examination found no issues with the markerbands of the device.
Event or Problem Description
It was reported that balloon burst occurred.The 70% stenosed target lesion was located in the mildly tortuous and non-calcified radial arteriovenous fistula.A mustang 7.0 x 200, 75cm balloon catheter was advanced for dilation.During the procedure, the balloon burst while blowing it inside the patient's body upon second inflation at over 10 atmospheres.The procedure was completed with another of the same device.No complications were reported, and the patient was stable.

• 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: 19857683
• Report Number: 2124215-2024-46729
• Device Sequence Number: 7513803
• Product Code: LIT
• UDI-Device Identifier: 08714729794189
• UDI-Public: 08714729794189
• 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: Other,Foreign,Health Professional,Company Representative,Distributor
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 09/03/2024

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 Model Number: 24673
• Device Catalogue Number: 24673
• Device Lot Number: 0033717384
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/09/2024
• Supplement Date Received by Manufacturer: 08/15/2024
• Initial Report FDA Received Date: 07/29/2024
• Supplement Report FDA Received Date: 09/03/2024
• 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
• Patient Age: 69 YR
• Patient Sex: Male