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

Model Number	24672
Medical Device Problem Code	Material Rupture (1546)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/19/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that balloon rupture occurred.The target lesion was located in the superficial femoral artery.A 6f non-boston scientific sheath was used for puncture and a v18 guidewire was crossed with the help of another non-boston scientific support catheter.After the guidewire was crossed, the 6f sheath was removed and a 3.0 x 150cm mustang balloon catheter was advanced and dilated gradually.Subsequently, after dilation, the 3.0 x 150cm balloon was removed and a 4.0 x 150, 135cm mustang balloon catheter was advanced.Upon initial inflation at 3-4 atmospheres for 2 seconds, it was found that the balloon was leaking liquid and became broke.The device was withdrawn and replaced with a new balloon.The angiography observes good vessel shape and a 4.0 x 150cm drug-balloon catheter was used for another dilation.Another angiography was performed, and no vessel dissection was noted.The device was removed, and the procedure was completed.No complications were reported, and the patient was stable.
Additional Manufacturer Narrative
Device evaluated by mfr: the mustang was returned 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 6mm in length and was located in the mid 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.
Event or Problem Description
It was reported that balloon rupture occurred.The target lesion was located in the superficial femoral artery.A 6f non-boston scientific sheath was used for puncture and a v18 guidewire was crossed with the help of another non-boston scientific support catheter.After the guidewire was crossed, the 6f sheath was removed and a 3.0 x 150cm mustang balloon catheter was advanced and dilated gradually.Subsequently, after dilation, the 3.0 x 150cm balloon was removed and a 4.0 x 150, 135cm mustang balloon catheter was advanced.Upon initial inflation at 3-4 atmospheres for 2 seconds, it was found that the balloon was leaking liquid and became broke.The device was withdrawn and replaced with a new balloon.The angiography observes good vessel shape and a 4.0 x 150cm drug-balloon catheter was used for another dilation.Another angiography was performed, and no vessel dissection was noted.The device was removed, and the procedure was completed.No complications were reported, and the patient was stable.

• 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: 19067810
• Report Number: 2124215-2024-21271
• Device Sequence Number: 12436335
• Product Code: LIT
• UDI-Device Identifier: 08714729793694
• UDI-Public: 08714729793694
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• 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
• Report Date (Section B): 05/03/2024

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: 08/11/2025
• Device Model Number: 24672
• Device Catalogue Number: 24672
• Device Lot Number: 0029940440
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/08/2024
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 03/19/2024
• Supplement Date Received by Manufacturer: 04/16/2024
• Initial Report FDA Received Date: 04/08/2024
• Supplement Report FDA Received Date: 05/03/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/12/2022
• 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: 78 YR
• Patient Sex: Male
• Patient Weight: 70 KG