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	12/11/2020
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that balloon rupture occurred.The 70-80% stenosed target lesion was located in the non-tortuous and moderately calcified arteriovenous fistula.A 8.0 x 100, 75cm mustang balloon catheter was advanced for dilatation.However, during inflation at 20 atmospheres (atm), the balloon ruptured.Subsequently, another 8.0 x 100, 75cm mustang balloon catheter was advanced for dilatation, but the balloon also ruptured at 20 atm.Both devices were removed and the procedure was completed with another of the same device.No patient complications were reported and the patient's status was stable.
Event or Problem Description
It was reported that balloon rupture occurred.The 70-80% stenosed target lesion was located in the non-tortuous and moderately calcified arteriovenous fistula.A 8.0 x 100, 75cm mustang balloon catheter was advanced for dilatation.However, during inflation at 20 atmospheres (atm), the balloon ruptured.Subsequently, another 8.0 x 100, 75cm mustang balloon catheter was advanced for dilatation, but the balloon also ruptured at 20 atm.Both devices were removed and the procedure was completed with another of the same device.No patient complications were reported and the patient's status was stable.
Additional Manufacturer Narrative
A mustang device was received for analysis.A visual examination identified that the balloon was not folded, and inflation media was present inside it which indicates that the balloon was subjected to positive pressure.The returned device was attached to an encore inflation unit and positive pressure was applied, the balloon was inflated to its rate of burst pressure of 20 atmospheres for 30 seconds without issue.A vacuum was then applied.The inflation device was verified at 20 atmospheres, before and after use with a calibrated pressure gauge.This inflation to rate of burst pressure of 20 atmospheres was repeated three times with no leaks or drop in pressure noted.No issues were identified with balloon inflation or the balloon material.No issues were noted with the tip section of the device.A visual and microscopic examination found no issue with the markerbands.A visual and tactile examination found that the shaft was severely stretched/damaged at more than one location.This type of damage is consistent with excessive tensile force being applied to the device.No issues were noted with the returned device which may have potentially contributed to the complaint incident.

• 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: 11133502
• Report Number: 2134265-2020-18461
• Device Sequence Number: 11764943
• Product Code: FGE
• UDI-Device Identifier: 08714729793700
• UDI-Public: 08714729793700
• Combination Product (Y/N): N
• Initial Reporter Country: SN
• 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): 01/26/2021

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: 09/17/2023
• Device Model Number: 24674
• Device Catalogue Number: 24674
• Device Lot Number: 0026034768
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/11/2021
• Initial Date Received by Manufacturer: 12/21/2020
• Supplement Date Received by Manufacturer: 01/22/2021
• Initial Report FDA Received Date: 01/07/2021
• Supplement Report FDA Received Date: 01/26/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1