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	04/22/2022
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that balloon rupture occurred.A 5.0 x 60, 75cm mustang balloon catheter was advanced for dilatation.However, during inflation, the balloon ruptured before reaching the nominal pressure.The procedure was completed with another of same device.No patient complications were reported and the patient status was stable.
Additional Manufacturer Narrative
Age at time of event: (b)(6).
Additional Manufacturer Narrative
A2-age at time of event: 18 years or older device evaluated by mfr.: a mustang device 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 31mm in length and extended from a position 10mm distal of the proximal markerband to 13mm proximal of the distal markerband.A visual examination observed 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.This concludes the product analysis.
Event or Problem Description
It was reported that balloon rupture occurred.A 5.0 x 60, 75cm mustang balloon catheter was advanced for dilatation.However, during inflation, the balloon ruptured before reaching the nominal pressure.The procedure was completed with another of same device.No patient complications were reported and the patient status was stable.It was further reported that the target lesion has 85% stenosis, non-calcified and non-tortuous.The balloon ruptured during first inflation at 3 bar.
Additional Manufacturer Narrative
A2-age at time of event: 18 years or older.
Event or Problem Description
It was reported that balloon rupture occurred.A 5.0 x 60, 75cm mustang balloon catheter was advanced for dilatation.However, during inflation, the balloon ruptured before reaching the nominal pressure.The procedure was completed with another of same device.No patient complications were reported and the patient status was stable.It was further reported that the target lesion has 85% stenosis, non-calcified and non-tortuous.The balloon ruptured during first inflation at 3 bar.

• 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: 14269790
• Report Number: 2134265-2022-05048
• Device Sequence Number: 14878679
• Product Code: FGE
• UDI-Device Identifier: 08714729793977
• UDI-Public: 08714729793977
• 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,Followup
• Report Date (Section B): 05/26/2022

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: 10/28/2023
• Device Model Number: 24674
• Device Catalogue Number: 24674
• Device Lot Number: 0026258699
• 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: 04/27/2022
• Supplement Date Received by Manufacturer: 05/02/2022; 05/23/2022
• Initial Report FDA Received Date: 05/03/2022
• Supplement Report FDA Received Date: 05/09/2022; 05/26/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/28/2020
• 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