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

Model Number 24672

Device Problem Leak/Splash (1354)

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

Event Date 03/15/2023

Event Type  malfunction  

Event Description

It was reported that balloon leak was encountered.The 70% stenosed target lesion was located in the subclavian vein.After a 6f sheath and a 5f guide catheter were crossed the lesion, a 8.0 x 120, 135cm mustang balloon catheter was advanced for dilatation.However, when the balloon was fully inflated at 14 atmospheres, the pressure was found to be increased and the inflation was abnormal.It was noted that the contrast agent was overflowing, and the balloon was leaking gas upon checking.The procedure was completed with another of the same device.There were no patient complications nor injuries reported and the patient condition was stable.

Manufacturer Narrative

The device was received for analysis.A visual examination identified that the balloon was not folded which indicates that the device was subjected to positive pressure.A balloon longitudinal tear was identified beginning approximately 5mm distal of the distal markerband and extending approximately 49mm proximally across the balloon material.As per mustang specification, the rated burst pressure for this device is 18 atmospheres.A visual examination observed no issues or damage to the tip of the device.A visual and tactile examination found no kinks or damage to the shaft of the device.A visual examination observed no issues with the markerbands of the device.Both markerbands were undamaged and present on the shaft of the device.

Event Description

It was reported that balloon leak was encountered.The 70% stenosed target lesion was located in the subclavian vein.After a 6f sheath and a 5f guide catheter were crossed the lesion, a 8.0 x 120, 135cm mustang balloon catheter was advanced for dilatation.However, when the balloon was fully inflated at 14 atmospheres, the pressure was found to be increased and the inflation was abnormal.It was noted that the contrast agent was overflowing, and the balloon was leaking gas upon checking.The procedure was completed with another of the same device.There were no patient complications nor injuries reported and the patient condition was stable.

• 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: jeff wallner ; 4100 hamline ave n; arden hills, MN 55112 ; 6515811560
• MDR Report Key: 16683778
• MDR Text Key: 312723148
• Report Number: 2124215-2023-15990
• Device Sequence Number: 1
• Product Code: FGE
• UDI-Device Identifier: 08714729794448
• UDI-Public: 08714729794448
• Combination Product (y/n): N
• Reporter Country Code: CH
• PMA/PMN Number: K103751
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative,Distributor
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 05/07/2023

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 Model Number: 24672
• Device Catalogue Number: 24672
• Device Lot Number: 0029640328
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/16/2023
• Initial Date FDA Received: 04/05/2023
• Supplement Dates Manufacturer Received: 04/26/2023
• Supplement Dates FDA Received: 05/07/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/23/2022
• 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
• Patient Age: 70 YR
• Patient Sex: Female
• Patient Weight: 65 KG