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

Model Number	24674
Medical Device Problem Code	Deflation Problem (1149)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/19/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that slow deflation on the balloon occurred.The patient underwent a percutaneous transluminal angioplasty.The 100% stenosed target lesion was located in the mildly tortuous and very severely calcified arteriovenous fistula.A 6.0 x 60, 75cm mustang balloon catheter was advanced for dilation.During the procedure, it was noted that the deflation time was too slow.The procedure was completed using this device.No complications reported, and patient status was good.It was further reported that an encore 26 was used for inflation.The saline-contrast ratio used was 50:50.There were no patient symptoms while balloon remained inflated and was simply pulled intact deflated.No further information on how long it took to remove the balloon and its specific atmospheric pressure and duration during inflation.No damages were noted on the device before or after use.
Event or Problem Description
It was reported that slow deflation on the balloon occurred.The patient underwent a percutaneous transluminal angioplasty.The 100% stenosed target lesion was located in the mildly tortuous and very severely calcified arteriovenous fistula.A 6.0 x 60, 75cm mustang balloon catheter was advanced for dilation.During the procedure, it was noted that the deflation time was too slow.The procedure was completed using this device.No complications reported, and patient status was good.

• 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: rache shields ; 4100 hamline ave n; arden hills, MN 55112 ; 6512422111
• MDR Report Key: 19090343
• Report Number: 2124215-2024-21670
• Device Sequence Number: 17920245
• 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): 06/10/2024

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: 09/04/2026
• Device Model Number: 24674
• Device Catalogue Number: 24674
• Device Lot Number: 0032354680
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 03/20/2024
• Supplement Date Received by Manufacturer: 05/17/2024
• Initial Report FDA Received Date: 04/11/2024
• Supplement Report FDA Received Date: 06/10/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 09/05/2023
• 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 Age: 55 YR
• Patient Sex: Male