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	07/24/2021
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that balloon rupture occurred.The target lesion was located in a shunt vessel.A 7.0 x 80, 75cm mustang balloon catheter was advanced for dilation.However, during inflation, the balloon ruptured.The device was removed and there were no patient complications reported and the patient was stable.
Event or Problem Description
It was reported that balloon rupture occurred.The target lesion was located in a shunt vessel.A 7.0 x 80, 75cm mustang balloon catheter was advanced for dilation.However, during inflation, the balloon ruptured.The device was removed and there were no patient complications reported and the patient was stable.It was further reported that the balloon ruptured during first inflation at 8 atmospheres for 60 seconds.The procedure was completed with another of the same device.
Additional Manufacturer Narrative
Device evaluated by mfr: mustang 7.0 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.The returned device was attached to an encore inflation unit.Positive pressure was applied but the balloon could not be inflated.The device was soaked in a water bath at a temperature of 37 degrees celsius to help soften any inflation media that may be present inside the inflation lumen before further inflation attempts were made.The device was removed from the bath and a visual and microscopic examination identified foreign material (fm) protruding from the inflation lumen inside the balloon.An examination of the balloon material identified no issues which could potentially have contributed to this complaint.For investigation purposes the balloon material was dissected to assist in the removal of the fm from the inflation lumen.The investigator was unable to remove the obstruction from the device.The investigator contacted manufacturing to assist in the identification the fm.Manufacturing positively identified the fm as a mandrel.The mandrel protruded from the inflation lumen for approximately 95mm was used during the manufacturing process.A visual and microscopic examination of the markerbands identified no issues which may potentially have contributed to the complaint incident.A visual and tactile examination found no kinks or damage to the shaft of the returned device.A visual and tactile examination identified no damage to the tip which may have potentially contributed to the complaint incident.No issues were identified during the product analysis.
Event or Problem Description
It was reported that balloon rupture occurred.The target lesion was located in a shunt vessel.A 7.0 x 80, 75cm mustang balloon catheter was advanced for dilation.However, during inflation, the balloon ruptured.The device was removed and there were no patient complications reported and the patient was stable.It was further reported that the balloon ruptured during first inflation at 8 atmospheres for 60 seconds.The procedure was completed with another of the same device.It was further reported that it was about 60% stenosed, non calcified, and moderately tortuous target lesion.
Additional Manufacturer Narrative
B5.Describe event or problem- updated.
Event or Problem Description
It was reported that balloon rupture occurred.The target lesion was located in a shunt vessel.A 7.0 x 80, 75cm mustang balloon catheter was advanced for dilation.However, during inflation, the balloon ruptured.The device was removed and there were no patient complications reported and the patient was stable.It was further reported that the balloon ruptured during first inflation at 8 atmospheres for 60 seconds.The procedure was completed with another of the same device.It was further reported that it was about 60% stenosed, non calcified, and moderately tortuous target lesion.

• 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: 12271419
• Report Number: 2134265-2021-09983
• Device Sequence Number: 20099228
• Product Code: FGE
• UDI-Device Identifier: 08714729794264
• UDI-Public: 08714729794264
• 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,Followup
• Report Date (Section B): 09/09/2021

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: 12/14/2023
• Device Model Number: 24674
• Device Catalogue Number: 24674
• Device Lot Number: 0026511131
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/12/2021
• Initial Date Received by Manufacturer: 07/24/2021
• Supplement Date Received by Manufacturer: 07/29/2021; 08/23/2021; 09/03/2021
• Initial Report FDA Received Date: 08/03/2021
• Supplement Report FDA Received Date: 08/11/2021; 09/01/2021; 09/09/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1