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

Model Number	24674
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	11/18/2019
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that shaft break occurred.The stenosed target lesion was located in the central vein.A 10.0 x 60, 75cm mustang balloon catheter was selected for use.However, during preparation, the balloon and catheter were totally broke.The procedure was completed with another of the same device.No patient complications were reported and patient condition was normal.
Event or Problem Description
It was reported that shaft break occurred.The stenosed target lesion was located in the central vein.A 10.0 x 60, 75cm mustang balloon catheter was selected for use.However, during preparation, the balloon and catheter were totally broke.The procedure was completed with another of the same device.No patient complications were reported and patient condition was normal.
Additional Manufacturer Narrative
Device evaluated by mfr.: the device was received in two sections as a result of a complete break of the shaft.A visual and tactile examination found the shaft of the device to be severely stretched beginning at the hub of the device and extending approximately 28mm distally along the shaft.The shaft was also completely detached at approximately 7mm distal of the hub.This type of damage is consistent with excessive tensile force being applied to the device.The device was received with the balloon protector in place on the device.A visual and microscopic examination identified that the balloon had been not been inflated.No issues were identified with the balloon material that may have contributed to the complaint incident.No issue was observed with the markerbands or tip of the device that may have contributed to the complaint incident.No other issues were identified during 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
• MDR Report Key: 9415876
• Report Number: 2134265-2019-14619
• Device Sequence Number: 13880915
• Product Code: FGE
• UDI-Device Identifier: 08714729794004
• UDI-Public: 08714729794004
• Combination Product (Y/N): N
• Initial Reporter Country: KS
• PMA/510(K) Number: K141521
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 02/06/2020

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: 05/12/2022
• Device Model Number: 24674
• Device Catalogue Number: 24674
• Device Lot Number: 0023778037
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/13/2019
• Initial Date Received by Manufacturer: 11/19/2019
• Supplement Date Received by Manufacturer: 01/17/2020
• Initial Report FDA Received Date: 12/05/2019
• Supplement Report FDA Received Date: 02/06/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 66 YR