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

Model Number	24674
Medical Device Problem Codes	Material Rupture (1546); Device-Device Incompatibility (2919)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/21/2022
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that balloon rupture occurred.The patient presented for percutaneous transluminal angioplasty.The target lesion was located in the subclavian artery.A 12.0 x 60, 75cm mustang balloon catheter was advanced for dilatation.However, during the procedure, the balloon burst.It was noted that the balloon seemed to have touched the stent tip and contrast was leaking.The procedure was completed with another of same device.There were no patient complications reported and the patient was fine.
Event or Problem Description
It was reported that balloon rupture occurred.The patient presented for percutaneous transluminal angioplasty.The target lesion was located in the subclavian artery.A 12.0 x 60, 75cm mustang balloon catheter was advanced for dilatation.However, during the procedure, the balloon burst.It was noted that the balloon seemed to have touched the stent tip and contrast was leaking.The procedure was completed with another of same device.There were no patient complications reported and the patient was fine.It was further reported that the stenosed target lesion was 80% located in mildly tortuous and severely calcified subclavian artery.Inflation was performed two times; however, at nominal atmospheres, the balloon ruptured due to the contrast leaking of the balloon.The device was removed completely from the patient body.
Event or Problem Description
It was reported that balloon rupture occurred.The patient presented for percutaneous transluminal angioplasty.The target lesion was located in the subclavian artery.A 12.0 x 60, 75cm mustang balloon catheter was advanced for dilatation.However, during the procedure, the balloon burst.It was noted that the balloon seemed to have touched the stent tip and contrast was leaking.The procedure was completed with another of same device.There were no patient complications reported and the patient was fine.It was further reported that the stenosed target lesion was 80% located in mildly tortuous and severely calcified subclavian artery.Inflation was performed two times; however, at nominal atmospheres, the balloon ruptured due to the contrast leaking of the balloon.The device was removed completely from the patient body.
Additional Manufacturer Narrative
Device evaluated by mfr.: a mustang device was returned.A visual examination identified that the balloon was not folded which indicates that the balloon was subjected to positive pressure.The rated burst pressure for this device is 14 atmospheres as per mustang specification.The returned device was attached to an encore inflation unit.Positive pressure was applied when liquid was observed to be leaking from a balloon pinhole located approximately 13mm proximal from the distal markerband.A visual and examination of the markerbands identified no issues.A visual and tactile examination identified no kinks or damage to the shaft.A visual and tactile examination identified no damage to the tip.

• Brand Name: MUSTANG
• Common Device Name: CATHETER, BILIARY, DIAGNOSTIC
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; two scimed place; maple grove MN 55311
• Manufacturer (Section G): BOSTON SCIENTIFIC CORPORATION; pmt 741 persiaran cassia selat; bandarcassia, pulau pinan 14110 ; MY 14110
• Manufacturer Contact: jay johnson ; 4100 hamline ave n; arden hills, MN 55112 ; 6515810888
• MDR Report Key: 15869231
• Report Number: 2124215-2022-48934
• Device Sequence Number: 5219200
• Product Code: FGE
• UDI-Device Identifier: 08714729794738
• UDI-Public: 08714729794738
• 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,Distributor
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 01/17/2023

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: 06/07/2025
• Device Model Number: 24674
• Device Catalogue Number: 24674
• Device Lot Number: 0029547629
• 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: 11/22/2022
• Supplement Date Received by Manufacturer: 12/04/2022; 01/17/2023
• Initial Report FDA Received Date: 11/28/2022
• Supplement Report FDA Received Date: 12/19/2022; 01/17/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/08/2022
• 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 Sex: Male