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

Model Number 24673

Device Problem Material Puncture/Hole (1504)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 09/13/2018

Event Type  malfunction  

Manufacturer Narrative

Age at time of event - 18 years or older.

Event Description

It was reported that balloon rupture occurred.The chronic totally occluded target lesion was located in the moderately tortuous and severely calcified superficial femoral artery (sfa).After a non-bsc guide wire crossed the lesion, a 4mm balloon catheter was advanced for dilatation.Since dilatation with 4mm balloon catheter was not sufficient, a 5.0 x 200, 135cm mustang balloon catheter was used to dilate the distal sfa.After that, the same balloon was also used to dilate the proximal sfa; however, on the second inflation, the balloon ruptured.The procedure was completed with no patient complications.

• Brand Name: MUSTANG
• Type of Device: CATHETER, BILIARY, DIAGNOSTIC
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; two scimed place; maple grove MN 55311
• Manufacturer (Section G): BOSTON SCIENTIFIC IRELAND LIMITED; ballybrit business park; galway ; EI
• Manufacturer Contact: sonali arangil ; two scimed place; maple grove, MN 55311 ; 6515827403
• MDR Report Key: 7941596
• MDR Text Key: 123732686
• Report Number: 2134265-2018-61640
• Device Sequence Number: 1
• Product Code: LIT
• UDI-Device Identifier: 08714729793373
• UDI-Public: 08714729793373
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K103751
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,distri
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 10/07/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/07/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 06/12/2021
• Device Model Number: 24673
• Device Catalogue Number: 24673
• Device Lot Number: 0022243976
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/13/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/13/2018
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1