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

Model Number	24674
Medical Device Problem Codes	Difficult to Remove (1528); Material Rupture (1546)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	12/31/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(6).
Event or Problem Description
It was reported that balloon rupture occurred.The 99% stenosed target lesion was located in a shunt in the moderately tortuous and moderately calcified vessel.A 6.0 x 20mm, 40cm mustang balloon catheter was used for dilation; however, during inflation the balloon ruptured.The procedure was completed with another of the same device and no patient complications were reported.
Additional Manufacturer Narrative
E1 initial reporter address: (b)(6).Device evaluated by mfr.: a mustang device was returned for analysis.The proximal section of device including the hub was not returned for analysis.A longitudinal tear was identified 3mm proximal of the proximal markerband extending 22mm distally.A visual and microscopic examination of the balloon material identified no issues that could have contributed to the complaint incident.A visual and microscopic examination of the markerbands identified no issues.The shaft was noted to be cut 70mm proximal from distal end of markerband.The proximal section of device including the hub was not returned for analysis.A visual and tactile examination identified no damage to the tip.No other issues were identified during the product analysis.
Event or Problem Description
It was reported that balloon rupture occurred.The 99% stenosed target lesion was located in a shunt in the moderately tortuous and moderately calcified vessel.A 6.0 x 20mm, 40cm mustang balloon catheter was used for dilation; however, during inflation the balloon ruptured.The procedure was completed with another of the same device and no patient complications were reported.
Additional Manufacturer Narrative
E1 initial reporter address: (b)(6).Device evaluated by mfr.: a mustang device was returned for analysis.The proximal section of device including the hub was not returned for analysis.A longitudinal tear was identified 3mm proximal of the proximal markerband extending 22mm distally.A visual and microscopic examination of the balloon material identified no issues that could have contributed to the complaint incident.A visual and microscopic examination of the markerbands identified no issues.The shaft was noted to be cut 70mm proximal from distal end of markerband.The proximal section of device including the hub was not returned for analysis.A visual and tactile examination identified no damage to the tip.No other issues were identified during the product analysis.B5 describe event or problem updated.
Event or Problem Description
It was reported that balloon rupture occurred.The 99% stenosed target lesion was located in a shunt in the moderately tortuous and moderately calcified vessel.A 6.0 x 20mm, 40cm mustang balloon catheter was used for dilation; however, during inflation the balloon ruptured.The procedure was completed with another of the same device and no patient complications were reported.It was further reported that resistance was felt during crossing the lesion and the device could not be removed from the sheath so shaft was cut.

• 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: 9897945
• Report Number: 2134265-2020-04053
• Device Sequence Number: 16848613
• Product Code: FGE
• UDI-Device Identifier: 08714729793908
• UDI-Public: 08714729793908
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• 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): 07/13/2020

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: 10/10/2022
• Device Model Number: 24674
• Device Catalogue Number: 24674
• Device Lot Number: 0024581015
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/25/2020
• Initial Date Received by Manufacturer: 03/11/2020
• Supplement Date Received by Manufacturer: 04/23/2020; 07/07/2020
• Initial Report FDA Received Date: 03/30/2020
• Supplement Report FDA Received Date: 04/27/2020; 07/13/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: INTRODUCER SHEATH: 5F SHEATH.; INTRODUCER SHEATH: 5F SHEATH.; INTRODUCER SHEATH: 5F SHEATH.