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	04/30/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that balloon rupture occurred.The patient underwent percutaneous transluminal angioplasty of the central vein.A 10.0 x 60, 75cm mustang balloon catheter was advanced for dilatation.However, during the procedure, the balloon burst.The procedure was completed with another of same product.No patient complications were reported.
Event or Problem Description
It was reported that balloon rupture occurred.The patient underwent percutaneous transluminal angioplasty of the central vein.A 10.0 x 60, 75cm mustang balloon catheter was advanced for dilatation.However, during the procedure, the balloon burst.The procedure was completed with another of same product.No patient complications were reported.It was further reported that the balloon was inflated twice at 12 atmospheres for 30 seconds respectively.
Additional Manufacturer Narrative
E1 - initial reporter phone: updated from blank to (b)(6).
Additional Manufacturer Narrative
E1 - initial reporter phone: updated from blank to (b)(6).Device evaluated by mfr: the device was received for analysis.A visual examination identified that the balloon was not folded which indicates that it was subjected to positive pressure.A partial balloon circumferential tear was identified located approximately 6mm distal of the proximal balloon sleeve.The balloon material was also torn longitudinally beginning at the circumferential tear and extending for approximately 10mm distally.No other issues were noted with the balloon material.No issues were noted with the shaft, markerbands or tip of the device.
Event or Problem Description
It was reported that balloon rupture occurred.The patient underwent percutaneous transluminal angioplasty of the central vein.A 10.0 x 60, 75cm mustang balloon catheter was advanced for dilatation.However, during the procedure, the balloon burst.The procedure was completed with another of same product.No patient complications were reported.It was further reported that the balloon was inflated twice at 12 atmospheres for 30 seconds respectively.

• 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; ballybrit business park; galway ; EI
• Manufacturer Contact: rachel shields ; 4100 hamline ave n; arden hills, MN 55112 ; 6512422111
• MDR Report Key: 19234272
• Report Number: 2124215-2024-26877
• Device Sequence Number: 6882686
• Product Code: FGE
• UDI-Device Identifier: 08714729794004
• UDI-Public: 08714729794004
• Combination Product (Y/N): N
• Initial Reporter Country: KS
• 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: Other,Foreign,Health Professional,Company Representative,Distributor
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 06/20/2024

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: 09/12/2024
• Device Model Number: 24674
• Device Catalogue Number: 24674
• Device Lot Number: 0028010765
• 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: 04/30/2024
• Supplement Date Received by Manufacturer: 05/08/2024; 06/18/2024
• Initial Report FDA Received Date: 05/02/2024
• Supplement Report FDA Received Date: 05/13/2024; 06/21/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/13/2021
• 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 Age: 73 YR
• Patient Sex: Female