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

Model Number	24673
Medical Device Problem Codes	Material Rupture (1546); Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	09/01/2021
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the balloon ruptured.A 7.0x200, 75cm mustang balloon was selected for use in an av fistulagram to treat severe subclavian vein stenosis.During the third inflation at 20atm, the balloon ruptured.Fragments remained in the vein.A snare was able to retrieve a couple of the balloon fragments.The distal tip and markers of the balloon were not retrievable.A stent was used to affix and oppose the remaining fragments to the vessel wall to avoid embolization.The procedure was completed.There were no patient complications.
Additional Manufacturer Narrative
Device eval by mfr: the device was received with the shaft in three sections due to a complete shaft break at three locations.The fourth section of the device was not returned for analysis.The balloon material was also completely detached from the device.A visual examination identified that the balloon was not folded which indicates that the balloon was subjected to positive pressure.The returned section of balloon material measured approximately 110mm and was completely detached from the device due to a complete circumferential tear located at the proximal balloon bond and another located approximately 110mm distal of the first.The remaining distal section of balloon material measuring approximately 90mm was not returned for analysis.The returned proximal section of balloon material was also found to be torn longitudinally along its entire length.A visual and tactile examination found the shaft of the device to have completely detached at three locations.The first shaft break was located approximately 40mm distal of the strain relief.The second was located approximately 5mm distal of the proximal balloon bond.The third was located approximately 140mm distal of the second break.This section of shaft was also found to be severely stretched/damaged and kinked at along its entire length.The distal section of the device including a section of shaft, the distal markerband, the tip of the device and a section of balloon material remained inside the patient and were not returned for analysis.This type of damage is consistent with resistance being encountered excessive tensile force being applied to the device when withdrawing it through the guide/sheath.A visual examination found that both markerbands were detached from the shaft of the device.The detached markerbands were not returned for analysis.
Event or Problem Description
It was reported that the balloon ruptured.A 7.0x200, 75cm mustang balloon was selected for use in an av fistulagram to treat severe subclavian vein stenosis.During the third inflation at 20atm, the balloon ruptured.Fragments remained in the vein.A snare was able to retrieve a couple of the balloon fragments.The distal tip and markers of the balloon were not retrievable.A stent was used to affix and oppose the remaining fragments to the vessel wall to avoid embolization.The procedure was completed.There were no patient complications.

• 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: 12558458
• Report Number: 2134265-2021-12117
• Device Sequence Number: 19663627
• Product Code: LIT
• UDI-Device Identifier: 08714729794189
• UDI-Public: 08714729794189
• Combination Product (Y/N): N
• Initial Reporter State: OR
• Initial Reporter Country: US
• 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: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 11/12/2021

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: 05/26/2023
• Device Model Number: 24673
• Device Catalogue Number: 24673
• Device Lot Number: 0025538941
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/18/2021
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 09/08/2021
• Supplement Date Received by Manufacturer: 11/04/2021
• Initial Report FDA Received Date: 09/30/2021
• Supplement Report FDA Received Date: 11/12/2021
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/26/2020
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 70 YR
• Patient Sex: Female