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	02/02/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Age at time of event: 18 years or older.
Event or Problem Description
It was reported that balloon rupture occurred.A 10.0 x 40, 135cm mustang balloon catheter was advanced for dilatation.However, during inflation before reaching the rated burst pressure, the balloon ruptured.The procedure was completed with another of same device.There were no patient complications reported and the patient status was stable.
Event or Problem Description
It was reported that balloon rupture occurred.A 10.0 x 40, 135cm mustang balloon catheter was advanced for dilatation.However, during inflation before reaching the rated burst pressure, the balloon ruptured.The procedure was completed with another of same device.There were no patient complications reported and the patient status was stable.It was further reported that the 70% stenosed target lesion was located in a non-tortuous and non-calcified arteriovenous shunt.The device was inflated first time and burst at 3 bar.The device was completely removed slowly and carefully from the patient.
Additional Manufacturer Narrative
(a2) age at time of event: 18 years or older.

• 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; ballybrit business park; galway ; EI
• Manufacturer Contact: jay johnson ; two scimed place; maple grove, MN 55311 ; 7634942574
• MDR Report Key: 13519153
• Report Number: 2134265-2022-01540
• Device Sequence Number: 14492668
• Product Code: FGE
• UDI-Device Identifier: 08714729793823
• UDI-Public: 08714729793823
• Combination Product (Y/N): N
• Initial Reporter Country: TW
• 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
• Report Date (Section B): 02/16/2022

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: 05/24/2024
• Device Model Number: 24674
• Device Catalogue Number: 24674
• Device Lot Number: 0027374614
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 02/07/2022
• Supplement Date Received by Manufacturer: 02/14/2022
• Initial Report FDA Received Date: 02/12/2022
• Supplement Report FDA Received Date: 02/16/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 05/25/2021
• 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: Unknown