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

Model Number	24674
Medical Device Problem Code	Failure to Deflate (4060)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/23/2023
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that deflation issue occurred.The 70% stenosed target lesion was located in the mildly tortuous and non-calcified arteriovenous fistula.A 6.0 x 60, 75-cm mustang balloon catheter was used for dilation.The patient was undergoing dialysis; however, the physician couldn't deflate the balloon.The physician removed the balloon physically, and the procedure was completed with another of same device.No further issues were reported.
Event or Problem Description
It was reported that deflation issue occurred.The 70% stenosed target lesion was located in the mildly tortuous and non-calcified arteriovenous fistula.A 6.0 x 60, 75-cm mustang balloon catheter was used for dilation for this patient undergoing dialysis; however, the physician couldn't deflate the balloon.The physician removed the balloon physically, and the procedure was completed with another of same device.No further issues were reported.
Additional Manufacturer Narrative
Device evaluated by mfr: a mustang device was received for analysis.A visual examination identified that the balloon was subjected to positive pressure.The returned device was attached to a boston scientific encore inflation unit and positive pressure was applied.The balloon was inflated to its rate of burst pressure of 24 atmospheres as per mustang specification with no leaks noted.The investigator was unable to deflate the balloon fully.The investigator dissected the shaft for further analysis and the balloon deflated immediately.The hub was dissected under manufacturing operations supervision and the initial review suggested that the patency inflation lumen was compromised.A visual examination of the marker bands identified no issues.A visual and tactile examination identified no issues with the shaft.A visual and tactile examination identified no issues with tip of this device.

• 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: 18125233
• Report Number: 2124215-2023-59823
• Device Sequence Number: 17743267
• Product Code: FGE
• UDI-Device Identifier: 08714729793762
• UDI-Public: 08714729793762
• 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: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 01/11/2024

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: 05/21/2026
• Device Model Number: 24674
• Device Catalogue Number: 24674
• Device Lot Number: 0031663845
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 10/23/2023
• Supplement Date Received by Manufacturer: 12/21/2023
• Initial Report FDA Received Date: 11/13/2023
• Supplement Report FDA Received Date: 01/11/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/22/2023
• 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