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

Model Number	24672
Medical Device Problem Codes	Deflation Problem (1149); Difficult to Advance (2920)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/20/2022
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that deflation failure occurred.The 90% stenosed target lesion was located in moderately tortuous and heavily calcified superficial femoral artery.A 4.0 x 150, 135cm mustang balloon catheter was advanced for dilatation.However, during the procedure there were problems noticed with the catheter and its progress while advancing.The device was then removed; however, the physician found it was hard to re-enter the lesion as probably it was not fully deflated.The procedure was completed with another of same device.There were no patient complications reported and the patient condition was stable.
Additional Manufacturer Narrative
Device evaluated by mfr.: mustang was received for analysis.A visual and tactile examination identified that the balloon was tightly folded and had not been subject to positive pressure.No issues were noted which may have potentially contributed to the complaint incident.A visual and tactile examination identified no kinks or damage to the shaft of the device.A visual examination identified no damage to the tip of the device.No other issues were identified during the product analysis.
Event or Problem Description
It was reported that deflation failure occurred.The 90% stenosed target lesion was located in moderately tortuous and heavily calcified superficial femoral artery.A 4.0 x 150, 135cm mustang balloon catheter was advanced for dilatation.However, during the procedure there were problems noticed with the catheter and its progress while advancing.The device was then removed; however, the physician found it was hard to re-enter the lesion as probably it was not fully deflated.The procedure was completed with another of same device.There were no patient complications reported and the patient condition was stable.

• 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: 14803181
• Report Number: 2134265-2022-06594
• Device Sequence Number: 4653511
• Product Code: LIT
• UDI-Device Identifier: 08714729793694
• UDI-Public: 08714729793694
• Combination Product (Y/N): N
• Initial Reporter Country: KS
• 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: Foreign,Health Professional,Company Representative,Distributor
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 08/10/2022

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: 02/18/2024
• Device Model Number: 24672
• Device Catalogue Number: 24672
• Device Lot Number: 0026829957
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/21/2022
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 06/02/2022
• Supplement Date Received by Manufacturer: 07/15/2022
• Initial Report FDA Received Date: 06/24/2022
• Supplement Report FDA Received Date: 08/10/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/18/2021
• 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: 73 YR
• Patient Sex: Male