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

Model Number	24672
Medical Device Problem Codes	Material Rupture (1546); Detachment of Device or Device Component (2907)
Health Effect - Clinical Codes	Pain (1994); Thrombosis/Thrombus (4440); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/01/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the balloon ruptured requiring an arteriotomy, to remove portions of the balloon.A 6.0 x 150, 135cm mustang balloon was used in a brachiocephalic fistuloplasty procedure for stenosis.The 85% to 90% stenosed lesion was located in the brachiocephalic artery, with moderate tortuosity and mild calcification.During the procedure the balloon was inflated two times, for two minutes.During the second inflation, the balloon ruptured at 20 atm.While removing the balloon, a portion of the balloon remained inside the brachial artery.At some point in the procedure the patient experienced severe pain and a thrombosis.Later, the patient underwent an arteriotomy to remove the balloon material.The patient has fully recovered and is doing better.The balloon will not be returned, as it was disposed of.
Event or Problem Description
It was reported that the balloon ruptured requiring an arteriotomy, to remove portions of the balloon.A 6.0 x 150, 135cm mustang balloon was used in a brachiocephalic fistuloplasty procedure for stenosis.The 85% to 90% stenosed lesion was located in the brachiocephalic artery, with moderate tortuosity and mild calcification.During the procedure the balloon was inflated two times, for two minutes.During the second inflation, the balloon ruptured at 20 atm.While removing the balloon, a portion of the balloon remained inside the brachial artery.At some point in the procedure the patient experienced severe pain and a thrombosis.Later, the patient underwent an arteriotomy to remove the balloon material.The patient has fully recovered and is doing better.The balloon will not be returned, as it was disposed of.It was further reported that the mustang balloon catheter did not contribute to the patient's thrombosis or pain, and there were no patient complications reported.
Additional Manufacturer Narrative
B5.Describe event or problem - corrected and updated.H6.Patient codes - corrected from thrombosis and pain to no clinical signs/symptoms h6.Impact codes - corrected and updated from device explanation to surgical intervention.

• 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: 17712848
• Report Number: 2124215-2023-49065
• Device Sequence Number: 2251018
• Product Code: LIT
• UDI-Device Identifier: 08714729793458
• UDI-Public: 08714729793458
• Combination Product (Y/N): N
• Initial Reporter Country: IN
• 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
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 10/09/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 09/27/2025
• Device Model Number: 24672
• Device Catalogue Number: 24672
• Device Lot Number: 0030233998
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 09/02/2023
• Supplement Date Received by Manufacturer: 09/10/2023
• Initial Report FDA Received Date: 09/08/2023
• Supplement Report FDA Received Date: 10/09/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 09/28/2022
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 47 YR
• Patient Sex: Female
• Patient Race: Asian