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	02/02/2020
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that balloon rupture occurred.The target lesion was 40.0 mm long, with a reference vessel diameter of 10.0 mm.A 10.0 x 40, 135cm mustang balloon catheter was advanced for dilation and a 10ml syringe was used for inflating the balloon with ratio of 50:50% saline and contrast.However, during injection of the solution for inflation, the balloon ruptured inside the vessel and the contrast was spilled.The device was removed from the patient's body and the procedure was completed with a 10x40 mustang balloon catheter.There were no patient complications reported.
Event or Problem Description
It was reported that balloon rupture occurred.The target lesion was 40.0 mm long, with a reference vessel diameter of 10.0 mm.A 10.0 x 40, 135cm mustang balloon catheter was advanced for dilation and a 10ml syringe was used for inflating the balloon with ratio of 50:50% saline and contrast.However, during injection of the solution for inflation, the balloon ruptured inside the vessel and the contrast was spilled.The device was removed from the patient's body and the procedure was completed with a 10x40 mustang balloon catheter.There were no patient complications reported.
Additional Manufacturer Narrative
Device evaluated b mfr.: a mustang 10.0 x 40, 135cm was returned for analysis.The returned device was loaded onto a mandrel and attached to an encore inflation unit.Positive pressure was applied, and a pinhole leak was identified 10mm proximal from the proximal markerband.No other issues were noted.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 which may potentially have contributed to the complaint incident.A visual and tactile examination identified no kinks or damage to the shaft which may have potentially contributed to the complaint incident.A visual and tactile examination identified no damage to the tip which may have potentially 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: 9747706
• Report Number: 2134265-2020-02017
• Device Sequence Number: 19529909
• Product Code: FGE
• UDI-Device Identifier: 08714729793823
• UDI-Public: 08714729793823
• Combination Product (Y/N): N
• Initial Reporter Country: IN
• 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
• Report Date (Section B): 04/01/2020

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: 09/15/2022
• Device Model Number: 24674
• Device Catalogue Number: 24674
• Device Lot Number: 0024439486
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/25/2020
• Initial Date Received by Manufacturer: 02/06/2020
• Supplement Date Received by Manufacturer: 03/19/2020
• Initial Report FDA Received Date: 02/24/2020
• Supplement Report FDA Received Date: 04/01/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 67 YR