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

Model Number	24674
Medical Device Problem Codes	Entrapment of Device (1212); Material Rupture (1546)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/11/2022
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that balloon rupture occurred.The 95% stenosed target lesion was located in the moderately tortuous and severely calcified superficial femoral artery.A 5.0 x 40, 135cm mustang balloon catheter was advanced for dilatation.However, during third inflation at 20 atmospheres for 3 seconds, the balloon ruptured.The device was removed and a pinhole in the center of the balloon was noticed.The procedure was completed with a different device.No patient complications nor injuries were reported and the patient status was good.
Additional Manufacturer Narrative
H6 device codes (1): added entrapment of device.
Event or Problem Description
It was reported that balloon rupture occurred.The 95% stenosed target lesion was located in the moderately tortuous and severely calcified superficial femoral artery.A 5.0 x 40, 135cm mustang balloon catheter was advanced for dilatation.However, during third inflation at 20 atmospheres for 3 seconds, the balloon ruptured.The device was removed and a pinhole in the center of the balloon was noticed.The procedure was completed with a different device.No patient complications nor injuries were reported and the patient status was good.It was further reported that the balloon had to be removed with the entire guidewire.

• 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; ballybrit business park; galway ; EI
• Manufacturer Contact: jay johnson ; two scimed place; maple grove, MN 55311 ; 7634942574
• MDR Report Key: 14604755
• Report Number: 2134265-2022-05871
• Device Sequence Number: 5041202
• Product Code: FGE
• UDI-Device Identifier: 08714729793465
• UDI-Public: 08714729793465
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• 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: Foreign,Health Professional,Company Representative,Distributor
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 06/22/2022

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: 10/13/2022
• Device Model Number: 24674
• Device Catalogue Number: 24674
• Device Lot Number: 0024588575
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 05/12/2022
• Supplement Date Received by Manufacturer: 06/02/2022
• Initial Report FDA Received Date: 06/06/2022
• Supplement Report FDA Received Date: 06/22/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 10/14/2019
• 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 Sex: Unknown