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	04/11/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that balloon rupture occurred.A 6.0 x 200, 75cm mustang balloon was advanced for dilation.However, while inflating the balloon inside the stent graft, the balloon burst.The procedure was completed with another of the same device.No patient complications were reported.
Additional Manufacturer Narrative
Device evaluated by mfr: the complaint device was received for product analysis.A visual examination identified that the balloon was tightly folded, which indicates that the device was not subjected to positive pressure.A leak test was carried out and the balloon was inflated to its rated burst pressure for 30 seconds using deionizes water and digital timer without issue.A vacuum was then applied.The inflation device was verified at 22 atmospheres, before and after use with calibrated pressure gauge.This inflation to rate of burst pressure was repeated three times with no leaks or drop in pressure noted.No issues were identified with balloon inflation or the balloon material.As per specification, the rated burst pressure for this device is 22 atmospheres.A visual examination observed no damage to the tip of the device.A visual and tactile examination found no kinks or damage to the shaft of the device.Both markerbands were undamaged and present in the correct position on the shaft of the device.This concludes the product analysis.
Event or Problem Description
It was reported that balloon rupture occurred.A 6.0 x 200, 75cm mustang balloon was advanced for dilation.However, while inflating the balloon inside the stent graft, the balloon burst.The procedure was completed with another of the same device.No patient complications were reported.It was further reported that the 100% stenosed target lesion was located in the severely tortuous and severely calcified vessel.The device was removed without any problem and the patient was in a very good condition post-procedure.
Event or Problem Description
It was reported that balloon rupture occurred.A 6.0 x 200, 75cm mustang balloon was advanced for dilation.However, while inflating the balloon inside the stent graft, the balloon burst.The procedure was completed with another of the same device.No patient complications were reported.It was further reported that the 100% stenosed target lesion was located in the severely tortuous and severely calcified vessel.The device was removed without any problem and the patient was in a very good condition post-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: 19113717
• Report Number: 2124215-2024-22782
• Device Sequence Number: 7102275
• Product Code: LIT
• UDI-Device Identifier: 08714729794509
• UDI-Public: 08714729794509
• 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): 05/22/2024

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: 02/07/2026
• Device Model Number: 24673
• Device Catalogue Number: 24673
• Device Lot Number: 0031008018
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 04/12/2024
• Supplement Date Received by Manufacturer: 04/18/2024; 05/13/2024
• Initial Report FDA Received Date: 04/16/2024
• Supplement Report FDA Received Date: 04/24/2024; 05/22/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/08/2023
• 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 Sex: Unknown