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

Model Number	24674
Medical Device Problem Code	Material Rupture (1546)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	01/14/2020
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that balloon rupture occurred.The stenosed target lesion was located in the subclavian vein.A 9.0 x 80, 75cm mustang balloon catheter was advanced for dilatation.However, upon inflation at 10 atmospheres, the balloon ruptured.The procedure was completed and no patient complications were reported.
Additional Manufacturer Narrative
B5: describe event or problem updated.(d4) lot number corrected from 0024818578 to 0024718627 (d4) expiration date corrected from 11/21/2022 to 11/04/2022 (h4) device manufacture date corrected from 11/22/2019 to 11/05/2019.
Event or Problem Description
It was reported that balloon rupture occurred.The stenosed target lesion was located in the subclavian vein.A 9.0 x 80, 75cm mustang balloon catheter was advanced for dilatation.However, upon inflation at 10 atmospheres, the balloon ruptured.The procedure was completed and no patient complications were reported.It was further reported that the 75% stenosed target lesion with mildly calcified and mildly tortuous subclavian vein.
Additional Manufacturer Narrative
B5: describe event or problem updated.(d4) lot number corrected from 0024818578 to 0024718627.(d4) expiration date corrected from 11/21/2022 to 11/04/2022.(h4) device manufacture date corrected from 11/22/2019 to 11/05/2019.Device evaluated by mfr.: the device was returned for analysis.A visual examination identified that the balloon was not folded which indicates that the balloon was subjected to positive pressure.A microscopic examination identified a balloon longitudinal tear beginning approximately 5mm distal of the proximal markerband and extending approximately 74mm distally across the balloon material.An examination of the balloon material and markerbands identified no issues which could potentially have contributed to this complaint.A visual and microscopic examination of the markerbands identified no issues which may potentially have contributed to the complaint incident.A visual and tactile examination found no kinks or damage to the shaft of the returned device.A visual and tactile examination identified no damage to the tip which may have potentially contributed to the complaint incident.No issues were identified during the product analysis.
Event or Problem Description
It was reported that balloon rupture occurred.The stenosed target lesion was located in the subclavian vein.A 9.0 x 80, 75cm mustang balloon catheter was advacned for dilatation.However, upon inflation at 10 atmospheres, the balloon ruptured.The procedure was completed and no patient complications were reported.It was further reported that the 75% stenosed target lesion with mildly calcified and mildly tortuous subclavian vein.

• 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: 9656548
• Report Number: 2134265-2020-00835
• Device Sequence Number: 11487434
• Product Code: FGE
• UDI-Device Identifier: 08714729794868
• UDI-Public: 08714729794868
• 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,distri
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 03/17/2020

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: 11/04/2022
• Device Model Number: 24674
• Device Catalogue Number: 24674
• Device Lot Number: 0024718627
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/31/2020
• Initial Date Received by Manufacturer: 01/14/2020
• Supplement Date Received by Manufacturer: 01/28/2020; 03/02/2020
• Initial Report FDA Received Date: 02/01/2020
• Supplement Report FDA Received Date: 02/19/2020; 03/17/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 61 YR