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	08/30/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Age at time of event: 18 years or older.Initial reporter facility name: (b)(6).
Event or Problem Description
It was reported that balloon rupture occurred.The stenosed target lesion was located in a shunt.A 6.0 x 80, 135cm mustang balloon catheter was advanced for dilatation.However, during inflation at 18 atmospheres, the balloon ruptured.Another 6.0 x 80, 135cm mustang balloon catheter was advanced but it also ruptured during inflation at 18 atmospheres.The procedure was completed with a different device.No patient complications were reported and the patient status was stable.
Additional Manufacturer Narrative
(a2) age at time of event: 18 years or older.(e1) initial reporter facility name: (b)(6) general hospital.Device evaluated by mfr: mustang 6.0 x 80, 135cm 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 microscopic examination identified a balloon longitudinal tear beginning approximately 4mm proximal of the proximal markerband and extending approximately 58mm distally across the balloon material.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 24 atmospheres.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.This concludes the product analysis.
Event or Problem Description
It was reported that balloon rupture occurred.The stenosed target lesion was located in a shunt.A 6.0 x 80, 135cm mustang balloon catheter was advanced for dilatation.However, during inflation at 18 atmospheres, the balloon ruptured.Another 6.0 x 80, 135cm mustang balloon catheter was advanced but it also ruptured during inflation at 18 atmospheres.The procedure was completed with a different device.No patient complications were reported and the patient status was stable.It was further reported that the target lesion was about 30% stenosed and was located in the superficial femoral artery.Both devices were not inflated to the nominal bar at about 5 seconds before it ruptured.Both devices were completely removed and was removed directly from the patient.
Additional Manufacturer Narrative
(a2) age at time of event: 18 years or older.(e1) initial reporter facility name: (b)(6) hospital.
Event or Problem Description
It was reported that balloon rupture occurred.The stenosed target lesion was located in a shunt.A 6.0 x 80, 135cm mustang balloon catheter was advanced for dilatation.However, during inflation at 18 atmospheres, the balloon ruptured.Another 6.0 x 80, 135cm mustang balloon catheter was advanced but it also ruptured during inflation at 18 atmospheres.The procedure was completed with a different device.No patient complications were reported and the patient status was stable.It was further reported that the target lesion was about 30% stenosed and was located in the superficial femoral artery.Both devices were not inflated to the nominal bar at about 5 seconds before it ruptured.Both devices were completely removed and was removed directly from the patient.

• Brand Name: MUSTANG
• Common Device Name: CATHETER, BILIARY, DIAGNOSTIC
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; two scimed place; maple grove MN 55311
• MDR Report Key: 12425667
• Report Number: 2134265-2021-11247
• Device Sequence Number: 3254910
• Product Code: FGE
• UDI-Device Identifier: 08714729793793
• UDI-Public: 08714729793793
• Combination Product (Y/N): N
• Initial Reporter Country: TW
• 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: company representative,distri
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 10/12/2021

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: 01/20/2024
• Device Model Number: 24674
• Device Catalogue Number: 24674
• Device Lot Number: 0026666967
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/16/2021
• Initial Date Received by Manufacturer: 08/30/2021
• Supplement Date Received by Manufacturer: 09/07/2021; 10/05/2021
• Initial Report FDA Received Date: 09/03/2021
• Supplement Report FDA Received Date: 09/16/2021; 10/12/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1