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

Model Number	24672
Medical Device Problem Codes	Difficult to Advance (2920); Material Integrity Problem (2978)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/23/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that balloon damage occurred.The target lesion was an area of in-stent restenosis located in the left iliac artery.A 5.0 x 150, 135cm mustang balloon catheter was advanced for dilatation.However, during introduction, the balloon was difficult to advance.The balloon was hooked by the stent and was damaged.Additionally, the physician found the dilation was not sufficient.The mustang balloon was removed from the patient and the procedure was completed by implanting another stent.There were no patient complications reported and the patient status was stable.
Additional Manufacturer Narrative
B5.Describe event or problem- updated.
Event or Problem Description
It was reported that balloon damage occurred.The target lesion was an area of in-stent restenosis located in the left iliac artery.A 5.0 x 150, 135cm mustang balloon catheter was advanced for dilatation.However, during introduction, the balloon was difficult to advance.The balloon was hooked by the stent and was damaged.Additionally, the physician found the dilation was not sufficient.The mustang balloon was removed from the patient and the procedure was completed by implanting another stent.There were no patient complications reported and the patient status was stable.It was further reported that before usage of the mustang balloon catheter, the patient had an implanted stent.The mustang was advanced for dilation but was unable to pass the stent and the device was hooked by the stent.The device was removed and no intervention was involved in removing the device.On the following day, stenting was performed as dilatation was not sufficient.Although dilatation was not sufficient, there were no inflation or dilatation issues noted on the mustang balloon catheter.

• 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: 14103099
• Report Number: 2134265-2022-04139
• Device Sequence Number: 15024093
• Product Code: LIT
• UDI-Device Identifier: 08714729793434
• UDI-Public: 08714729793434
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• 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,Followup
• Report Date (Section B): 05/16/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 07/12/2024
• Device Model Number: 24672
• Device Catalogue Number: 24672
• Device Lot Number: 0027660237
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 03/24/2022
• Supplement Date Received by Manufacturer: 04/19/2022
• Initial Report FDA Received Date: 04/13/2022
• Supplement Report FDA Received Date: 05/16/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 07/13/2021
• 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
• Outcome Attributed to Adverse Event: Other
• Patient Age: 59 YR
• Patient Sex: Male
• Patient Weight: 48 KG