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	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/10/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that balloon rupture occurred.A 7.0 x 100, 135cm mustang balloon catheter was advanced for dilation.During the procedure, the balloon ruptured.The device was successfully removed, and it was noted that rupture was in the form of a pinhole.Another of the same device was used to complete the procedure.No complications reported, and patient status was good.
Additional Manufacturer Narrative
Device evaluated by mfr.: the device was returned for analysis and underwent a visual and tactile examination.The returned device was attached to an encore inflation unit.Positive pressure was applied when di water was observed to be leaking from a balloon pinhole located opposite the proximal markerband.No issues, kinks, or damages were identified in the markerband, shaft, and tip of the device.
Event or Problem Description
It was reported that balloon rupture occurred.A 7.0 x 100, 135cm mustang balloon catheter was advanced for dilation.During the procedure, the balloon ruptured.The device was successfully removed, and it was noted that rupture was in the form of a pinhole.Another of the same device was used to complete the procedure.No complications reported, and patient status was good.It was further reported that the anatomical location of the procedure was in the iliac artery (common iliac artery to external iliac artery).The target lesion was approximately 90% severe stenosis and was severely tortuous and moderately calcified.

• 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: 19376983
• Report Number: 2124215-2024-31412
• Device Sequence Number: 20764619
• Product Code: FGE
• UDI-Device Identifier: 08714729794011
• UDI-Public: 08714729794011
• 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,Followup
• Report Date (Section B): 06/28/2024

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: 09/03/2026
• Device Model Number: 24674
• Device Catalogue Number: 24674
• Device Lot Number: 0032349296
• 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: 05/13/2024
• Supplement Date Received by Manufacturer: 06/05/2024
• Initial Report FDA Received Date: 05/22/2024
• Supplement Report FDA Received Date: 06/28/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/04/2023
• 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