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	09/02/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that balloon rupture occurred.The target lesion was located in the radial arteriovenous fistula.A 7.0 x 200, 75cm mustang balloon catheter was advanced for dilation.During the procedure, the balloon burst while inflating inside the patient.The device was removed and replaced for another of the same model to complete the procedure.No complications reported, and patient status was stable.
Event or Problem Description
It was reported that balloon rupture occurred.The target lesion was located in the radial arteriovenous fistula.A 7.0 x 200, 75cm mustang balloon catheter was advanced for dilation.During the procedure, the balloon burst while inflating inside the patient.The device was removed and replaced for another of the same model to complete the procedure.No complications reported, and patient status was stable.It was further reported that the target lesion was 60-70% stenosed, moderately tortuous, and mildly calcified.The balloon ruptured on the second inflation at 18 atmospheres for 60 seconds.
Additional Manufacturer Narrative
B5.Describe event or problem: was updated per the additional information provided.
Additional Manufacturer Narrative
B5.Describe event or problem: was updated per the additional information provided.The device was returned for analysis, and the evaluation was completed on 05nov2024.A visual and tactile examination was performed.A complete balloon circumferential tear was identified located approximately 58mm distal of the proximal markerband.As the distal section of balloon material had been pulled distal over the tip of the device.There were no damages or kinks found on the shaft ad markerbands of the device.With a rupture in the balloon material an optimum balloon refold would have been compromised.With a compromised balloon refold the device would have encountered resistance at the guide/sheath on removal from the patient.The complete balloon circumferential tear most probably occurred due to the user applying excessive tensile force when attempting to withdraw the device through the sheath on removal.
Event or Problem Description
It was reported that balloon rupture occurred.The target lesion was located in the radial arteriovenous fistula.A 7.0 x 200, 75cm mustang balloon catheter was advanced for dilation.During the procedure, the balloon burst while inflating inside the patient.The device was removed and replaced for another of the same model to complete the procedure.No complications reported, and patient status was stable.It was further reported that the target lesion was 60-70% stenosed, moderately tortuous, and mildly calcified.The balloon ruptured on the second inflation at 18 atmospheres for 60 seconds.

• 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: 20341852
• Report Number: 2124215-2024-60815
• Device Sequence Number: 12778032
• 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,Followup
• Report Date (Section B): 11/26/2024

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: 0034170601
• 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: 09/02/2024
• Supplement Date Received by Manufacturer: 09/29/2024; 11/05/2024
• Initial Report FDA Received Date: 10/01/2024
• Supplement Report FDA Received Date: 10/14/2024; 11/26/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/05/2024
• 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: 70 YR
• Patient Sex: Male