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

Model Number 24672

Device Problem Material Rupture (1546)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 12/19/2019

Event Type  malfunction  

Event Description

It was reported that balloon rupture occurred.The 100% stenosed target lesion was located in the moderately tortuous and severely calcified right superior femoral artery.After crossing a v18 guide wire, a 7.0 x 150, 75cm mustang catheter was advanced for pre-dilatation.However, during inflation at nominal pressure, the balloon ruptured.The device was replaced with another mustang balloon and the procedure was completed with a non-bsc stent.There were no patient complications reported.

Manufacturer Narrative

E1 - initial reporter city: (b)(6).Device evaluated by mfr.: the device 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 55mm proximal from the distal 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.

Event Description

It was reported that balloon rupture occurred.The 100% stenosed target lesion was located in the moderately tortuous and severely calcified right superior femoral artery.After crossing a v18 guide wire, a 7.0 x 150, 75cm mustang catheter was advanced for pre-dilatation.However, during inflation at nominal pressure, the balloon ruptured.The device was replaced with another mustang balloon and the procedure was completed with a non-bsc stent.There were no patient complications reported.

• Brand Name: MUSTANG
• Type of Device: CATHETER, BILIARY, DIAGNOSTIC
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; two scimed place; maple grove MN 55311
• MDR Report Key: 9534750
• MDR Text Key: 177152312
• Report Number: 2134265-2019-16293
• Device Sequence Number: 1
• Product Code: LIT
• UDI-Device Identifier: 08714729794578
• UDI-Public: 08714729794578
• Combination Product (y/n): N
• PMA/PMN Number: K103751
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,distri
• Type of Report: Initial,Followup
• Report Date: 02/14/2020

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
• Device Operator: Health Professional
• Device Expiration Date: 08/01/2021
• Device Model Number: 24672
• Device Catalogue Number: 24672
• Device Lot Number: 0022460774
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/02/2020
• Initial Date Manufacturer Received: 12/19/2019
• Initial Date FDA Received: 12/31/2019
• Supplement Dates Manufacturer Received: 01/30/2020
• Supplement Dates FDA Received: 02/14/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1