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

Model Number	24674
Medical Device Problem Code	Difficult to Advance (2920)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/05/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the procedure was cancelled.A 7.0 x 20, 135cm mustang balloon was selected to be used in an angioplasty procedure of the mesenteric artery.The mustang balloon was advanced for dilation; however, it had difficulty advancing into the 7 french guide catheter.It was then attempted to advance the stent, and the express ld vascular never passed the tip of the catheter.As a result, the dilation treatment could not be performed, and the procedure was postponed for a later date.There were no patient complications reported.
Additional Manufacturer Narrative
D4: lot number updated.G1: manufacturing site address updated.H4: device manufacture date updated.Device evaluation by manufacturer: a mustang device, 20 atm was received for analysis.The recommended introducer/guide sheath size for this device is minimum 5fr sheath.The sheath used by the customer was not returned for analysis.During analysis the investigator applied negative pressure to the device and successfully advanced it through a boston scientific 5fr sheath and withdrew with no issues noted.A visual examination identified that the balloon was not subjected to positive pressure.No issues were identified with the balloon material.A visual and tactile examination identified no damage to the shaft of the device.A visual examination identified no damage to the tip of the device.This concludes the product analysis.
Event or Problem Description
It was reported that the procedure was cancelled.A 7.0 x 20, 135cm mustang balloon was selected to be used in an angioplasty procedure of the mesenteric artery.The mustang balloon was advanced for dilation; however, it had difficulty advancing into the 7 french guide catheter.It was then attempted to advance the stent, and the express ld vascular never passed the tip of the catheter.As a result, the dilation treatment could not be performed, and the procedure was postponed for a later date.There were no patient complications reported.

• 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 MA 14110 ; MY 14110
• Manufacturer Contact: rachel shields ; 4100 hamline ave n; arden hills, MN 55112 ; 6512422111
• MDR Report Key: 19158214
• Report Number: 2124215-2024-23407
• Device Sequence Number: 7443966
• Product Code: FGE
• UDI-Device Identifier: 08714729793830
• UDI-Public: 08714729793830
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• 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
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 06/03/2024

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: 10/05/2026
• Device Model Number: 24674
• Device Catalogue Number: 24674
• Device Lot Number: 0032580257
• 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: 04/12/2024
• Supplement Date Received by Manufacturer: 05/13/2024
• Initial Report FDA Received Date: 04/22/2024
• Supplement Report FDA Received Date: 06/03/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/06/2023
• 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
• Concomitant Medical Products and Therapy/Usage Dates: EXPRESS LD VASCULAR.; EXPRESS LD VASCULAR.
• Patient Sex: Unknown