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	04/12/2021
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.The target lesion was located in a shunt.A 7.0 x 120, 75cm mustang balloon catheter was advanced for dilation.However, when the balloon was inflated below the maximum rated burst pressure, the balloon ruptured.The procedure was completed with another of same device.There were no patient complications reported and the patient was stable.
Additional Manufacturer Narrative
A2.Age at time of event: 18 years or older.
Event or Problem Description
It was reported that balloon rupture occurred.The target lesion was located in a shunt.A 7.0 x 120, 75cm mustang balloon catheter was advanced for dilation.However, when the balloon was inflated below the maximum rated burst pressure, the balloon ruptured.The procedure was completed with another of same device.There were no patient complications reported and the patient was stable.It was further reported that the balloon ruptured during inflation at 2 atmospheres for 5 seconds.
Additional Manufacturer Narrative
A2.Age at time of event: 18 years or older.
Event or Problem Description
It was reported that balloon rupture occurred.The target lesion was located in a shunt.A 7.0 x 120, 75cm mustang balloon catheter was advanced for dilation.However, when the balloon was inflated below the maximum rated burst pressure, the balloon ruptured.The procedure was completed with another of same device.There were no patient complications reported and the patient was stable.It was further reported that the balloon ruptured during inflation at 2 atmospheres for 5 seconds.It was further reported that the target lesion was about 65% stenosed non-tortuous and non-calcified.

• Brand Name: MUSTANG
• Common Device Name: CATHETER, BILIARY, DIAGNOSTIC
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; two scimed place; maple grove MN 55311
• MDR Report Key: 11759366
• Report Number: 2134265-2021-05500
• Device Sequence Number: 17266198
• Product Code: FGE
• UDI-Device Identifier: 08714729794424
• UDI-Public: 08714729794424
• Combination Product (Y/N): N
• Initial Reporter Country: TW
• 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: company representative,distri
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 06/23/2021

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: 04/21/2023
• Device Model Number: 24672
• Device Catalogue Number: 24672
• Device Lot Number: 0025456465
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 04/12/2021
• Supplement Date Received by Manufacturer: 04/29/2021; 06/10/2021
• Initial Report FDA Received Date: 05/03/2021
• Supplement Report FDA Received Date: 05/13/2021; 06/23/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1