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

Model Number	24674
Medical Device Problem Code	Material Rupture (1546)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/16/2021
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that balloon rupture occurred.The patient presented with iliac vein compression and leg swelling.The mild stenosed target lesion was located in the mildly tortuous and mildly calcified iliac vein.The patient had iliac vein compression.A 12.0 x 80, 75cm mustang balloon catheter was selected for pre-dilation and there was no damage on the outer package of the balloon.The device was loaded onto the guidewire and was inflated at less than 2 atmospheres for few seconds.However, it was noticed that liquid was leaking on the balloon and the pressure would not increase.Upon examination, there was pinhole or tear on the balloon.The procedure was completed with another of 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 rupture occurred.The patient presented with iliac vein compression and leg swelling.The mild stenosed target lesion was located in the mildly tortuous and mildly calcified iliac vein.The patient had iliac vein compression.A 12.0 x 80, 75cm mustang balloon catheter was selected for pre-dilation and there was no damage on the outer package of the balloon.The device was loaded onto the guidewire and was inflated at less than 2 atmospheres for few seconds.However, it was noticed that liquid was leaking on the balloon and the pressure would not increase.Upon examination, there was pinhole or tear on the balloon.The procedure was completed with another of same device.There were no patient complications nor injuries reported and the patient status was stable.
Additional Manufacturer Narrative
Device evaluated by mfr.: mustang 12.0 x 80, 75cm was received for analysis.A visual examination identified that the balloon was not folded which indicates that the device was subjected to positive pressure.A balloon pinhole was identified located approximately 12mm distal of the distal markerband.An examination of the balloon material and markerbands identified no issues which could potentially have contributed to this complaint.A visual and microscopic examination of the markerbands identified no issues which may potentially have contributed to the complaint incident.A visual and tactile examination identified no kinks or damage to the shaft which may have potentially contributed to the complaint incident.A visual and tactile examination identified no damage to the tip which may have potentially contributed to the complaint incident.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: 12358731
• Report Number: 2134265-2021-10711
• Device Sequence Number: 3812433
• 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): 01/26/2022

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: 12/16/2023
• Device Model Number: 24674
• Device Catalogue Number: 24674
• Device Lot Number: 0026528068
• 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: 08/16/2021
• Supplement Date Received by Manufacturer: 01/19/2022
• Initial Report FDA Received Date: 08/24/2021
• Supplement Report FDA Received Date: 01/26/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/16/2020
• 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: 79 YR
• Patient Sex: Male
• Patient Weight: 56 KG