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

Model Number	24673
Medical Device Problem Code	Material Rupture (1546)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/27/2023
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that balloon rupture occurred.The patient was being treated for femoral artery stenosis.A 5.0 x 180, 135cm mustang balloon catheter was advanced for dilatation.However, during inflation, the balloon burst when the pressure reached 15 atmospheres.The device was withdrawn and replaced with another of same device, and the procedure was completed successfully.There were no complications reported and the patient status was stable.
Additional Manufacturer Narrative
Device evaluated by mfr: the 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 leak test identified a pinhole in the shaft of the device.A visual examination found no issues with the balloon material.No issue was observed with the tip or markerbands of the device which could have contributed to the complaint incident.A visual and tactile examination found no kinks or damage to the shaft of the device.A leak test identified a pinhole in the shaft located approximately 3mm proximal of the proximal balloon cone.This type of damage could potentially have been due to the device having an interaction with a sharp object or another device.
Event or Problem Description
It was reported that balloon rupture occurred.The patient was being treated for femoral artery stenosis.A 5.0 x 180, 135cm mustang balloon catheter was advanced for dilatation.However, during inflation, the balloon burst when the pressure reached 15 atmospheres.The device was withdrawn and replaced with another of same device, and the procedure was completed successfully.There were no complications reported and the patient status was stable.It was further reported that the 55% stenosed target lesion was located in the moderately tortuous and mildly calcified femoral artery.
Event or Problem Description
It was reported that balloon rupture occurred.The patient was being treated for femoral artery stenosis.A 5.0 x 180, 135cm mustang balloon catheter was advanced for dilatation.However, during inflation, the balloon burst when the pressure reached 15 atmospheres.The device was withdrawn and replaced with another of same device, and the procedure was completed successfully.There were no complications reported and the patient status was stable.It was further reported that the 55% stenosed target lesion was located in the moderately tortuous and mildly calcified femoral artery.

• 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: 18253089
• Report Number: 2124215-2023-68281
• Device Sequence Number: 6582241
• Product Code: LIT
• UDI-Device Identifier: 08714729794219
• UDI-Public: 08714729794219
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• 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): 01/19/2024

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: 07/27/2025
• Device Model Number: 24673
• Device Catalogue Number: 24673
• Device Lot Number: 0029848359
• 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: 11/28/2023
• Supplement Date Received by Manufacturer: 12/07/2023; 01/16/2024
• Initial Report FDA Received Date: 12/01/2023
• Supplement Report FDA Received Date: 12/07/2023; 01/19/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/28/2022
• 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: 59 YR
• Patient Sex: Female
• Patient Weight: 61 KG