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	03/21/2023
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that balloon rupture occurred.The patient was presented with atherosclerotic obliterans.The target lesion was located in lower extremity artery.A 6.0 x 80, 135cm mustang balloon catheter was advanced for dilatation.However, during procedure at 20 atmospheres (atm), the balloon ruptured.The device was removed, and the procedure was completed with another of same device.There were no patient complications nor injuries were reported and the patient was stable following procedure.
Event or Problem Description
It was reported that balloon rupture occurred.The patient was presented with atherosclerotic obliterans.The target lesion was located in lower extremity artery.A 6.0 x 80, 135cm mustang balloon catheter was advanced for dilatation.However, during procedure at 20 atmospheres (atm), the balloon ruptured.The device was removed, and the procedure was completed with another of same device.There were no patient complications nor injuries were reported and the patient was stable following procedure.It was further reported that target lesion was located in non-tortuous and locally severe calcified lower extremity artery.The balloon inflated once and ruptured at 20 atm in 8-10 seconds.
Additional Manufacturer Narrative
E2 - health professional? updated from no to yes.
Additional Manufacturer Narrative
Device evaluated by mfr.: a mustang device was received for analysis.A visual examination identified that the balloon was not folded which indicates that the balloon was subjected to positive pressure.A longitudinal tear was identified in the balloon material.The tear measured 17mm in length and was located in the mid to proximal region of the balloon.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 on the shaft of the device.B5 - describe event or problem updated.E2 - health professional? updated from no to yes.
Event or Problem Description
It was reported that balloon rupture occurred.The patient was presented with atherosclerotic obliterans.The target lesion was located in lower extremity artery.A 6.0 x 80, 135cm mustang balloon catheter was advanced for dilatation.However, during procedure at 20 atmospheres (atm), the balloon ruptured.The device was removed, and the procedure was completed with another of same device.There were no patient complications nor injuries were reported and the patient was stable following procedure.It was further reported that target lesion was located in non-tortuous and locally severe calcified lower extremity artery.The balloon inflated once and ruptured at 20 atm in 8-10 seconds.

• 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: jeff wallner ; 4100 hamline ave n; arden hills, MN 55112 ; 6515811560
• MDR Report Key: 16633106
• Report Number: 2124215-2023-14584
• Device Sequence Number: 20643905
• Product Code: FGE
• UDI-Device Identifier: 08714729793793
• UDI-Public: 08714729793793
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• 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): 05/24/2023

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: 02/13/2025
• Device Model Number: 24674
• Device Catalogue Number: 24674
• Device Lot Number: 0028863477
• 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: 03/21/2023
• Supplement Date Received by Manufacturer: 04/03/2023; 05/11/2023
• Initial Report FDA Received Date: 03/28/2023
• Supplement Report FDA Received Date: 04/11/2023; 05/24/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/14/2022
• 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: 58 YR
• Patient Sex: Male
• Patient Weight: 65 KG