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

Model Number	24674
Medical Device Problem Codes	Break (1069); Material Rupture (1546)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/17/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(6).
Event or Problem Description
It was reported that shaft break occurred.The patient presented with nephritis.A 6.0 x 80, 40cm mustang balloon catheter was advanced for dilatation.However, during the procedure, the device was broken.The procedure was completed with another of same device.There were no complications reported and the patient status was stable.
Additional Manufacturer Narrative
E1- facility name: (b)(6) hospital.E1 - initial reporter phone: +(b)(6).
Event or Problem Description
It was reported that shaft break occurred.The patient presented with nephritis.A 6.0 x 80, 40cm mustang balloon catheter was advanced for dilatation.However, during the procedure, the device was broken.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 balloon ruptured, and the shaft did not break as what was previously reported.The target lesion was 70% stenosed, moderately tortuous and severely calcified.

• 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; ballybrit business park; galway ; EI
• Manufacturer Contact: rachel shields ; 4100 hamline ave n; arden hills, MN 55112 ; 6512422111
• MDR Report Key: 18029566
• Report Number: 2124215-2023-60018
• Device Sequence Number: 7017990
• Product Code: FGE
• UDI-Device Identifier: 08714729795148
• UDI-Public: 08714729795148
• 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
• Report Date (Section B): 11/06/2023

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: 12/01/2023
• Device Model Number: 24674
• Device Catalogue Number: 24674
• Device Lot Number: 0026441276
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 10/20/2023
• Supplement Date Received by Manufacturer: 10/27/2023
• Initial Report FDA Received Date: 10/30/2023
• Supplement Report FDA Received Date: 11/06/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 12/01/2020
• 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
• Patient Age: 62 YR
• Patient Sex: Female
• Patient Weight: 59 KG