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

Model Number	24672
Medical Device Problem Codes	Material Rupture (1546); Difficult to Advance (2920)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/10/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
E1 - initial reporter address 1: (b)(6).
Event or Problem Description
It was reported that balloon rupture occurred.Vascular access was obtained via the right femoral artery.The 70% stenosed, 7mm x 3mm target lesion was located in the non-tortuous and moderately calcified superficial femoral artery.A 5.0 x 150, 135cm mustang balloon catheter was advanced for pre-dilatation.However, during introduction, the device failed to pass through a 6fr sheath.The sheath and the 0.035 260cm zipwire guidewire were replaced but the device was difficult to track over the guidewire.During the first inflation at 5 atmospheres for 30 seconds, the balloon ruptured.The device was removed, and the procedure was completed with another of same device.There were no complications reported and the patient status was stable.
Additional Manufacturer Narrative
E1: initial reporter address 1: (b)(6).These two complaints ((b)(4) and (b)(4)) were created to capture the event of balloon ruptured and advancing issue.However, based on the gfe response, this complaint is a duplicate of the (b)(4).Therefore, only one complaint will remain open to capture the problem and the other complaint (b)(4) will be closed as 'duplicate'.Any relevant information regarding the reported event will be captured by the complaint under (b)(4).
Event or Problem Description
It was reported that balloon rupture occurred.Vascular access was obtained via the right femoral artery.The 70% stenosed, 7mm x 3mm target lesion was located in the non-tortuous and moderately calcified superficial femoral artery.A 5.0 x 150, 135cm mustang balloon catheter was advanced for pre-dilatation.However, during introduction, the device failed to pass through a 6fr sheath.The sheath and the 0.035 260cm zipwire guidewire were replaced but the device was difficult to track over the guidewire.During the first inflation at 5 atmospheres for 30 seconds, the balloon ruptured.The device was removed, and the procedure was completed with another of same device.There were no complications reported and the patient status was stable.

• 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: 18465676
• Report Number: 2124215-2024-00264
• Device Sequence Number: 15240037
• Product Code: LIT
• UDI-Device Identifier: 08714729793434
• UDI-Public: 08714729793434
• Combination Product (Y/N): N
• Initial Reporter Country: EG
• 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: Other,Foreign,Health Professional,Company Representative,Distributor
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 02/06/2024

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: 10/03/2025
• Device Model Number: 24672
• Device Catalogue Number: 24672
• Device Lot Number: 0030271238
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 12/26/2023
• Supplement Date Received by Manufacturer: 01/18/2024
• Initial Report FDA Received Date: 01/08/2024
• Supplement Report FDA Received Date: 02/06/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 10/04/2022
• 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: GUIDE CATHETER: 5FR BERN; GUIDE CATHETER: 5FR BERN; GUIDEWIRE: 0.035 260CM ZIPWIRE; GUIDEWIRE: 0.035 260CM ZIPWIRE
• Patient Age: 57 YR
• Patient Sex: Male
• Patient Weight: 80 KG