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	08/13/2023
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that balloon rupture occurred.The target lesion was located in the iliac vein.A 10.0 x 80, 75cm mustang balloon catheter was advanced for dilatation.However, during inflation at 20 atmospheres, the balloon ruptured.The procedure was completed with another mustang balloon.There were no patient complications nor injuries reported.
Event or Problem Description
It was reported that balloon rupture occurred.The target lesion was located in the iliac vein.A 10.0 x 80, 75cm mustang balloon catheter was advanced for dilatation.However, during inflation at 20 atmospheres, the balloon ruptured.The procedure was completed with another mustang balloon.There were no patient complications nor injuries reported.It was further reported that the stenosed target lesion was 70%, located in the severely tortuous and severely calcified iliac vein.The balloon inflated two times and ruptured at 18 atmospheres in 2 minutes and not 20 atmospheres as previously reported.The patient condition was stable after the procedure.
Additional Manufacturer Narrative
H6 evaluation method codes from device not returned (b17) to device discarded (b18).

• 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: 17556790
• Report Number: 2124215-2023-43697
• Device Sequence Number: 19739584
• Product Code: FGE
• UDI-Device Identifier: 08714729794332
• UDI-Public: 08714729794332
• Combination Product (Y/N): N
• Initial Reporter Country: KS
• 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: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 08/31/2023

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: 01/19/2026
• Device Model Number: 24674
• Device Catalogue Number: 24674
• Device Lot Number: 0030888466
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 08/13/2023
• Supplement Date Received by Manufacturer: 08/27/2023
• Initial Report FDA Received Date: 08/16/2023
• Supplement Report FDA Received Date: 08/31/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 01/20/2023
• 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 Age: 75 YR
• Patient Sex: Male