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

Model Number 24674

Device Problem Difficult to Advance (2920)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 09/18/2023

Event Type  malfunction  

Manufacturer Narrative

Device evaluated by mfr: mustang 10.0 x 60, 75cm was received for analysis.A visual examination identified that the balloon was not folded which indicates that the balloon was subjected to positive pressure.A balloon longitudinal tear was identified beginning approximately 25mm distal of the proximal markerband and extending approximately 11mm distally across the balloon material.The rated burst pressure for this device is 14 atmospheres.A visual and tactile examination found no kinks or damage to the shaft of the device.A visual and tactile examination found no damage to the tip of the device.A visual examination observed no issues with the markerbands of the device.Both markerbands were undamaged in the correct position on the device.

Event Description

Reportable based on device analysis completed on 15-nov-2023.It was reported that advancing difficulties were encountered.Vascular access was obtained via contralateral approach.The 100% stenosed target lesion was located in the severely tortuous common iliac artery.A 10.0 x 60, 75cm mustang balloon catheter was advanced for dilation.However, during the procedure, the device did not move in the opposite direction during the contralateral approach process.The procedure was completed with another of the same device.No patient complications were reported.However, returned device analysis revealed balloon longitudinal tear.

• Brand Name: MUSTANG
• Type of Device: CATHETER, BILIARY, DIAGNOSTIC
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 300 boston scientific way; marlborough MA 01752
• Manufacturer (Section G): BOSTON SCIENTIFIC CORPORATION; pmt 741 persiaran cassia selat; bandarcassia, pulau pinan 14110 ; MY 14110
• Manufacturer Contact: rachel shields ; 4100 hamline ave n; arden hills, MN 55112 ; 6512422111
• MDR Report Key: 18162328
• MDR Text Key: 328511351
• Report Number: 2124215-2023-64770
• Device Sequence Number: 1
• Product Code: FGE
• UDI-Device Identifier: 08714729794004
• UDI-Public: 08714729794004
• Combination Product (y/n): N
• Reporter Country Code: KS
• PMA/PMN Number: K141521
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Health Professional,Company Representative,Distributor
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 11/17/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/17/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 24674
• Device Catalogue Number: 24674
• Device Lot Number: 0030382053
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/31/2023
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/15/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/20/2022
• 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