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

Model Number	24674
Medical Device Problem Codes	Break (1069); Fracture (1260); Material Rupture (1546); Detachment of Device or Device Component (2907); Device Dislodged or Dislocated (2923)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	05/03/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that balloon rupture, balloon detachment and loose radiopaque (ro) marker band occurred.The 90% stenosed target lesion was located in the mildly tortuous and severely calcified fistula of the left arm.A 8.0 x 20, 135cm mustang balloon catheter was advanced for dilation.However, during second inflation, the balloon ruptured.When the device was removed, the shaft broke 10mm from the hub and the balloon broke off from the shaft.The ro markers came off and were on the wire.The physician tried to removed the detached balloon with a snare but was unsuccessful.A non-boston scientific device was deployed to secure the balloon pieces.No patient complications were reported and the patient status is stable.A follow-up with the patient was conducted and the fistula was working fine.
Event or Problem Description
It was reported that balloon rupture, balloon detachment and loose radiopaque (ro) marker band occurred.The 90% stenosed target lesion was located in the mildly tortuous and severely calcified fistula of the left arm.A 8.0 x 20, 135cm mustang balloon catheter was advanced for dilation.However, during second inflation, the balloon ruptured.When the device was removed, the shaft broke 10mm from the hub and the balloon broke off from the shaft.The ro markers came off and were on the wire.The physician tried to removed the detached balloon with a snare but was unsuccessful.A non-boston scientific device was deployed to secure the balloon pieces.No patient complications were reported and the patient status is stable.A follow-up with the patient was conducted and the fistula was working fine.
Additional Manufacturer Narrative
Device evaluated by mfr.: the mustang 8.0 x 20, 135cm was received for analysis.The device was received with a section completely detached.The detached section of device was not returned for analysis.A visual examination identified that the balloon was not folded which indicates that it was subjected to positive pressure.A complete circumferential tear located approximately 17 mm distal of the proximal balloon sleeve.The distal section of balloon material 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 approximately 7mm distal of the proximal balloon bond.The distal section of the device including a section of shaft, both markerband, the tip of the device and a section of balloon material 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.The tip of the device was not returned for analysis.Both markerbands were not returned for 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; pmt 741 persiaran cassia selat; bandarcassia, pulau pinan 14110 ; MY 14110
• Manufacturer Contact: jay johnson ; two scimed place; maple grove, MN 55311 ; 7634942574
• MDR Report Key: 14476558
• Report Number: 2134265-2022-05288
• Device Sequence Number: 20164115
• Product Code: FGE
• UDI-Device Identifier: 08714729793847
• UDI-Public: 08714729793847
• Combination Product (Y/N): N
• Initial Reporter State: SC
• Initial Reporter Country: US
• 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: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 06/26/2022

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: 24674
• Device Catalogue Number: 24674
• Device Lot Number: 0027657116
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 05/03/2022
• Supplement Date Received by Manufacturer: 05/31/2022
• Initial Report FDA Received Date: 05/23/2022
• Supplement Report FDA Received Date: 06/26/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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: Required Intervention
• Patient Sex: Female