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

Model Number	24674
Medical Device Problem Codes	Leak/Splash (1354); Material Rupture (1546)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/23/2021
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that balloon leak occurred.The stenosed target lesion was located in the central vein.A 12.0 x 80, 75cm mustang balloon catheter was advanced for pre-dilation.However, after introducing the balloon through the guide wire and being prepared for dilation, it was found out that the balloon was leaking liquid and there was no pressure on the pressure pump.The physician checked the balloon and found out that it was damaged.There was no visible pinhole noted in either the shaft or the balloon.The procedure was completed with another of the same device.There were no patient complications nor injuries reported and the patient status was stable.
Event or Problem Description
It was reported that balloon leak occurred.The stenosed target lesion was located in the central vein.A 12.0 x 80, 75cm mustang balloon catheter was advanced for pre-dilation.However, after introducing the balloon through the guide wire and being prepared for dilation, it was found out that the balloon was leaking liquid and there was no pressure on the pressure pump.The physician checked the balloon and found out that it was damaged.There was no visible pinhole noted in either the shaft or the balloon.The procedure was completed with another of the same device.There were no patient complications nor injuries reported and the patient status was stable.
Additional Manufacturer Narrative
A mustang 12.0 x 80, 75cm was returned for analysis.A visual examination identified that the balloon was not folded which indicates that it was subjected to positive pressure.A partial balloon circumferential tear was identified located approximately 5mm proximal of the proximal balloon markerband.From the partial circumferential tear the balloon was also torn longitudinally for approximately 90mm distally.An examination of the balloon material and markerbands identified no issues which could potentially have contributed to this complaint.A visual and microscopic 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.This concludes the product analysis.

• 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: 12938833
• Report Number: 2134265-2021-15030
• Device Sequence Number: 4955897
• Product Code: FGE
• UDI-Device Identifier: 08714729794745
• UDI-Public: 08714729794745
• 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: Foreign,Health Professional,Company Representative,Distributor
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 02/09/2022

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: 03/29/2024
• Device Model Number: 24674
• Device Catalogue Number: 24674
• Device Lot Number: 0027060887
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/11/2022
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 11/23/2021
• Supplement Date Received by Manufacturer: 01/17/2022
• Initial Report FDA Received Date: 12/06/2021
• Supplement Report FDA Received Date: 02/09/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/30/2021
• 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: 50 YR
• Patient Sex: Male
• Patient Weight: 68 KG