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	10/04/2022
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that balloon rupture occurred.The patient presented with abdominal aneurysm.The target lesion was moderately tortuous.After a guiding sheath was tried to advance near the lesion but failed, a v-18 was crossed the lesion.A 6f non-boston scientific (bsc) guiding sheath was tried to advance while anchoring a 4.0 x 40, 135cm mustang balloon catheter for dilation.It went smoothly on the first three attempts, however, during the fourth deflation, the balloon ruptured.The guiding sheath was able to deliver almost to the target lesion, and additional balloon was not used.A non-bsc device was used for delivery along with the v-18 guidewire.It was noticed that there was a kink on the v-18 guidewire and delivery was difficult.V-18 was replaced with a new one and then a non-bsc device was delivered and placed.The procedure was completed without any complications nor injuries to the patient.

• Brand Name: MUSTANG
• Common Device Name: CATHETER, BILIARY, DIAGNOSTIC
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; two scimed place; maple grove MN 55311
• Manufacturer (Section G): BOSTON SCIENTIFIC CORPORATION; pmt 741 persiaran cassia selat; bandarcassia, pulau pinan 14110 ; MY 14110
• Manufacturer Contact: jay johnson ; 4100 hamline ave n; arden hills, MN 55112 ; 6515810888
• MDR Report Key: 15573038
• Report Number: 2124215-2022-40150
• Device Sequence Number: 2796982
• Product Code: FGE
• UDI-Device Identifier: 08714729793557
• UDI-Public: 08714729793557
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K103751
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative,Distributor
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 10/10/2022

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: 08/23/2023
• Device Model Number: 24674
• Device Catalogue Number: 24674
• Device Lot Number: 0025902137
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 10/04/2022
• Initial Report FDA Received Date: 10/10/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 08/23/2020
• 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: GUIDE CATHETER - DESTINATION 6FR
• Patient Sex: Unknown