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

Model Number	24674
Medical Device Problem Codes	Material Rupture (1546); Detachment of Device or Device Component (2907); Device-Device Incompatibility (2919)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/03/2021
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that balloon rupture and tip detachment occurred.The greater than 50% stenosed target lesion was an area of in-stent restenosis located in the cephalic vein.A 10.0 x 80, 75cm mustang balloon catheter was advanced to dilate a previously placed stent.However, during inflation, the balloon ruptured and the tip of the balloon broke off inside the patient.It was suspected that the balloon tip was caught on the end of a stent strut.The physician was able to remove the balloon catheter and sheath but couldn't get the non-bsc guidewire and the balloon tip.The physician sutured a perchik button over the access site and the wire was secured to the patient's arm.The patient underwent surgery to remove the wire and the balloon tip successfully.No patient complications were reported.
Event or Problem Description
It was reported that balloon rupture and tip detachment occurred.The greater than 50% stenosed target lesion was an area of in-stent restenosis located in the cephalic vein.A 10.0 x 80, 75cm mustang balloon catheter was advanced to dilate a previously placed stent.However, during inflation, the balloon ruptured and the tip of the balloon broke off inside the patient.It was suspected that the balloon tip was caught on the end of a stent strut.The physician was able to remove the balloon catheter and sheath but couldn't get the non-bsc guidewire and the balloon tip.The physician sutured a perchik button over the access site and the wire was secured to the patient's arm.The patient underwent surgery to remove the wire and the balloon tip successfully.No patient complications were reported.
Additional Manufacturer Narrative
Device evaluated by mfr.: mustang 10.0 x 80, 75cm was received for analysis.A visual examination identified that the balloon was not folded which indicates that the balloon was subjected to positive pressure.A complete balloon circumferential tear was identified located approximately 55mm distal of the proximal balloon sleeve.The remaining distal section of balloon material was not returned for analysis.No other issues were noted with the balloon material.A visual and tactile examination found the shaft of the device to have completely detached at the proximal balloon sleeve.The distal section of the shaft, including both markerbands, the tip of the device and distal 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.The tip of the device together with a section of shaft, a section of balloon material, and both markerbands were not returned for analysis.A visual examination found that both markerbands were detached from the device.The detached markerbands together with the distal section of shaft, a section of balloon material and tip of the device 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; ballybrit business park; galway ; EI
• Manufacturer Contact: jay johnson ; two scimed place; maple grove, MN 55311 ; 7634942574
• MDR Report Key: 13044578
• Report Number: 2134265-2021-15877
• Device Sequence Number: 16576179
• Product Code: FGE
• UDI-Device Identifier: 08714729794332
• UDI-Public: 08714729794332
• Combination Product (Y/N): N
• Initial Reporter State: SD
• 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): 02/02/2022

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: 08/24/2023
• Device Model Number: 24674
• Device Catalogue Number: 24674
• Device Lot Number: 0025904406
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/04/2022
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 12/06/2021
• Supplement Date Received by Manufacturer: 01/13/2022
• Initial Report FDA Received Date: 12/20/2021
• Supplement Report FDA Received Date: 02/02/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/24/2020
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown