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

Model Number	24674
Medical Device Problem Code	Failure to Advance (2524)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/28/2022
Type of Reportable Event	Malfunction
Event or Problem Description
Reportable based on device analysis completed on 28-sep-2022.It was reported that crossing difficulties were encountered.The target lesion was located in the tortuous arteriovenous fistula.A 7.0 x 80, 75cm mustang balloon catheter was advanced but failed to cross the lesion.The procedure was completed with another of the same device.There were no patient complications reported and the patient condition was good.However, returned device analysis revealed balloon torn.
Additional Manufacturer Narrative
Device evaluated by mfr.: mustang 7.0 x 80, 75cm was received for analysis.A visual examination identified that the balloon was not folded which indicates that the device was subjected to positive pressure.It is not known when the device was inflated.A balloon longitudinal tear was identified beginning at the distal markerband and extending approximately 48mm proximally across the balloon material.An examination of the balloon material and markerbands identified no issues which could potentially have contributed to this complaint.The rated burst pressure for this device is 20 atmospheres.A visual examination observed no issues or damage to the tip of the device.A visual and tactile examination found no kinks or damage the shaft of the device.A visual examination observed no issues with the markerbands of the device.Both markerbands were undamaged and present on the shaft of the device.This concludes the product analysis.

• Brand Name: MUSTANG
• Common Device Name: CATHETER, BILIARY, DIAGNOSTIC
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; two scimed place; maple grove MN 55311
• Manufacturer (Section G): BOSTON SCIENTIFIC CORPORATION; ballybrit business park; galway ; EI
• Manufacturer Contact: jay johnson ; 4100 hamline ave n; arden hills, MN 55112 ; 6515810888
• MDR Report Key: 15662151
• Report Number: 2124215-2022-38999
• Device Sequence Number: 2809940
• Product Code: FGE
• UDI-Device Identifier: 08714729794264
• UDI-Public: 08714729794264
• 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: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 10/24/2022

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: 06/23/2024
• Device Model Number: 24674
• Device Catalogue Number: 24674
• Device Lot Number: 0027556558
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/14/2022
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 09/28/2022
• Initial Report FDA Received Date: 10/24/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/24/2021
• 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: 68 YR
• Patient Sex: Male