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

Model Number	24674
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/09/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Device evaluated by mfr: a mustang device was received for analysis.A visual examination identified that the balloon was not folded which indicates that the device was subjected to positive pressure.A microscopic examination identified a balloon pinhole located at the distal markerband.An examination of the balloon material and distal markerband identified no issues which could potentially have contributed to this complaint.An examination of the tip, shaft and markerbands identified no issues which could potentially have contributed to this complaint.No other issues were identified during analysis.
Event or Problem Description
Reportable based on device analysis completed on 26jan2021.It was reported that a balloon leak occurred.Vascular access was obtained via the right common femoral artery.The target lesion was located in the severely calcified and mildly tortuous superior mesenteric artery.Due to the heavily calcified arteries they were unable to insert another manufacturers guide catheter into both the common femoral and common iliac arteries, so angioplasty of the right common iliac was performed to aid in the guide catheter insertion.Another manufactures 6fr sheath was advanced within the common femoral artery and a.035 amplatz super stiff guidewire was used to cross the lesion.This 3.0 x 40 75cm mustang balloon catheter was then inserted into the common iliac artery; the mustang device was inflated using an inflation device however the balloon did not inflate and contrast was seen coming out of the balloon.The device was successfully removed with no fragments remaining inside the patient.Another of the same device was used to complete the procedure.No patient complications were reported, and the procedure was successfully completed.Device analysis revealed balloon pinhole.

• Brand Name: MUSTANG
• Common Device Name: CATHETER, BILIARY, DIAGNOSTIC
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; two scimed place; maple grove MN 55311
• MDR Report Key: 11280090
• Report Number: 2134265-2021-01272
• Device Sequence Number: 2689037
• Product Code: FGE
• UDI-Device Identifier: 08714729793946
• UDI-Public: 08714729793946
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• PMA/510(K) Number: K103751
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 02/04/2021

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: 10/08/2023
• Device Model Number: 24674
• Device Catalogue Number: 24674
• Device Lot Number: 0026151296
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/11/2021
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 01/26/2021
• Initial Report FDA Received Date: 02/04/2021
• Patient Sequence Number: 1