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

Model Number	24673
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/07/2022
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that shaft break occurred.A 6.0 x 200, 75cm mustang balloon catheter was selected for use in a lower limb angioplasty.After flushing the balloon shaft, the physician tried to remove the balloon protective sheath.However, during preparation, the protective sheath and the balloon broke off from the main shaft.The procedure was completed with another of same device.No patient complications were reported and the patient status was stable.
Event or Problem Description
It was reported that shaft break occurred.A 6.0 x 200, 75cm mustang balloon catheter was selected for use in a lower limb angioplasty.After flushing the balloon shaft, the physician tried to remove the balloon protective sheath.However, during preparation, the protective sheath and the balloon broke off from the main shaft.The procedure was completed with another of same device.No patient complications were reported and the patient status was stable.
Additional Manufacturer Narrative
Device evaluated by mfr.: a mustang device was received for analysis.The device was received in sections.A visual examination identified that the balloon protector was still on the balloon and the balloon was not subjected to positive pressure.No issues were noted with the balloon, markerbands or tip.A visual examination of the balloon protector identified damage.A visual examination of the shaft identified that it was detached 2mm from the proximal balloon sleeve.Multiple shaft kinks were also noted.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; pmt 741 persiaran cassia selat; bandarcassia, pulau pinan 14110 ; MY 14110
• Manufacturer Contact: jay johnson ; two scimed place; maple grove, MN 55311 ; 7634942574
• MDR Report Key: 13404005
• Report Number: 2134265-2022-00427
• Device Sequence Number: 19293460
• Product Code: LIT
• UDI-Device Identifier: 08714729794509
• UDI-Public: 08714729794509
• Combination Product (Y/N): N
• Initial Reporter Country: SN
• 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
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 02/22/2022

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: 08/29/2024
• Device Model Number: 24673
• Device Catalogue Number: 24673
• Device Lot Number: 0027927162
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/20/2022
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 01/11/2022
• Supplement Date Received by Manufacturer: 02/04/2022
• Initial Report FDA Received Date: 01/31/2022
• Supplement Report FDA Received Date: 02/22/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/30/2021
• 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 Sex: Unknown