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 Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/06/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A4 - weight: 52.50 kg.
Event or Problem Description
It was reported that balloon rupture occurred.The target lesion was located in an internal fistula in the right forearm radial artery to cephalic vein.After opening the cephalic vein stenosis of the right upper arm with a 4f single curved catheter and 0.035 guidewire, the guidewire entered the right subclavian vein.The catheter was withdrawn and a 7.0 x 60, 75cm mustang balloon catheter was advanced along the guidewire for dilatation.However, during inflation, the balloon ruptured.The procedure was completed with another of same device.There were no complications reported and the patient status was stable.
Additional Manufacturer Narrative
A4 - weight: 52.50 kg.Device evaluated by mfr: the device was returned for analysis.A visual examination identified that the balloon was not folded which indicates that the balloon was subjected to positive pressure.A longitudinal tear was identified in the balloon material.The tear measured 5mm in length and extended from a position 8mm proximal of the distal markerband to 13mm proximal of the distal markerband.A visual examination observed no damage to the tip of the device.A visual and tactile examination found no kinks or damage to the shaft of the device.Both markerbands were undamaged and present on the shaft of the device.
Event or Problem Description
It was reported that balloon rupture occurred.The target lesion was located in an internal fistula in the right forearm radial artery to cephalic vein.After opening the cephalic vein stenosis of the right upper arm with a 4f single curved catheter and 0.035 guidewire, the guidewire entered the right subclavian vein.The catheter was withdrawn and a 7.0 x 60, 75cm mustang balloon catheter was advanced along the guidewire for dilatation.However, during inflation, the balloon ruptured.The procedure was completed with another of same device.There were no complications reported and the patient status was stable.It was further reported that the target lesion was 75% stenosed, moderately tortuous, and moderately calcified.The balloon ruptured during the second inflation at 20-24 atmospheres for 15-20 seconds.The device was removed without any difficulty.
Event or Problem Description
It was reported that balloon rupture occurred.The target lesion was located in an internal fistula in the right forearm radial artery to cephalic vein.After opening the cephalic vein stenosis of the right upper arm with a 4f single curved catheter and 0.035 guidewire, the guidewire entered the right subclavian vein.The catheter was withdrawn and a 7.0 x 60, 75cm mustang balloon catheter was advanced along the guidewire for dilatation.However, during inflation, the balloon ruptured.The procedure was completed with another of same device.There were no complications reported and the patient status was stable.It was further reported that the target lesion was 75% stenosed, moderately tortuous, and moderately calcified.The balloon ruptured during the second inflation at 20-24 atmospheres for 15-20 seconds.The device was removed without any difficulty.
Additional Manufacturer Narrative
A4 - weight: 52.50 kg.

• Brand Name: MUSTANG
• Common Device Name: 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: 18109898
• Report Number: 2124215-2023-63104
• Device Sequence Number: 17500018
• Product Code: FGE
• UDI-Device Identifier: 08714729793861
• UDI-Public: 08714729793861
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K141521
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Health Professional,Company Representative,Distributor
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 12/07/2023

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
• Operator of Device: Health Professional
• Device Expiration Date: 04/06/2025
• Device Model Number: 24674
• Device Catalogue Number: 24674
• Device Lot Number: 0029184916
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 11/06/2023
• Supplement Date Received by Manufacturer: 11/13/2023; 12/07/2023
• Initial Report FDA Received Date: 11/10/2023
• Supplement Report FDA Received Date: 11/17/2023; 12/07/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/07/2022
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: 0.035 GUIDEWIRE; 0.035 GUIDEWIRE; 0.035 GUIDEWIRE; 4F SINGLE CURVED CATHETER; 4F SINGLE CURVED CATHETER; 4F SINGLE CURVED CATHETER
• Patient Age: 61 YR
• Patient Sex: Female