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	11/25/2021
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that balloon rupture occurred.The target lesion was located in the iliac vein.A 10.0 x 80, 135cm mustang balloon catheter was advanced for dilatation.However, during the procedure, sharp plaque were encountered and during inflation, the balloon ruptured.The procedure was completed with another of the same device.There were no patient complications nor injuries reported and the patient status was stable.
Additional Manufacturer Narrative
Updated b5: describe event or problem.
Event or Problem Description
It was reported that balloon rupture occurred.The target lesion was located in the iliac vein.A 10.0 x 80, 135cm mustang balloon catheter was advanced for dilatation.However, during the procedure, sharp plaque were encountered and during inflation, the balloon ruptured.The procedure was completed with another of the same device.There were no patient complications nor injuries reported and the patient status was stable.It was further reported that the balloon was inflated once at less working pressure for few seconds before it ruptured.
Additional Manufacturer Narrative
Device evaluated by mfr.: mustang 10.0 x 80, 135cm was received for analysis.As per mustang specification, the recommended sheath for this device is minimum 6fr.The sheath used by the customer was not returned 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 20mm distal of the proximal balloon sleeve.The distal section of balloon material had been pulled distally over the tip of the device and was torn longitudinally along its entire length.This would suggest that the complete circumferential tear occurred when the device was being withdrawn from the patient.An examination of the balloon material and markerbands identified no issues which could potentially have contributed to this complaint.As per mustang specification the rated burst pressure for this device is 14atm.A visual and microscopic examination observed no damage to the tip of the device.A visual and tactile examination found no kinks or damage to the shaft of the device.Both markerbands were undamaged and present on the shaft of the device.
Event or Problem Description
It was reported that balloon rupture occurred.The target lesion was located in the iliac vein.A 10.0 x 80, 135cm mustang balloon catheter was advanced for dilatation.However, during the procedure, sharp plaque were encountered and during inflation, the balloon ruptured.The procedure was completed with another of the same device.There were no patient complications nor injuries reported and the patient status was stable.It was further reported that the balloon was inflated once at less working pressure for few seconds before it ruptured.

• 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: 12987406
• Report Number: 2134265-2021-15659
• Device Sequence Number: 17396942
• Product Code: FGE
• UDI-Device Identifier: 08714729795254
• UDI-Public: 08714729795254
• 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,Followup
• Report Date (Section B): 01/28/2022

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: 03/29/2024
• Device Model Number: 24674
• Device Catalogue Number: 24674
• Device Lot Number: 0027058744
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/05/2022
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 12/02/2021
• Supplement Date Received by Manufacturer: 12/09/2021; 01/14/2022
• Initial Report FDA Received Date: 12/13/2021
• Supplement Report FDA Received Date: 12/21/2021; 01/28/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/30/2021
• 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
• Patient Age: 66 YR
• Patient Sex: Male
• Patient Weight: 71 KG