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

Model Number	24674
Medical Device Problem Codes	Difficult to Remove (1528); Material Rupture (1546)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/20/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that balloon rupture and difficulty removal occurred resulting to an additional intervention.The 75% stenosed target lesion was located in the moderately tortuous pulmonary artery.A 12.0 x 40, 135cm mustang balloon catheter was advanced for dilation.However, during second inflation at 10 atmospheres for 20 seconds, the balloon ruptured horizontally.The device was removed with a snare because the balloon was lifted and was stuck.The procedure was completed with another of the same device.There were no patient complications reported and the patient was in good condition post procedure.
Event or Problem Description
It was reported that balloon rupture and difficulty removal occurred resulting to an additional intervention.The 75% stenosed target lesion was located in the moderately tortuous pulmonary artery.A 12.0 x 40, 135cm mustang balloon catheter was advanced for dilation.However, during second inflation at 10 atmospheres for 20 seconds, the balloon ruptured horizontally.The device was removed with a snare because the balloon was lifted and was stuck.The procedure was completed with another of the same device.There were no patient complications reported and the patient was in good condition post procedure.
Additional Manufacturer Narrative
Device evaluated by mfr: a mustang device was returned for analysis.As per mustang specification, the recommended sheath for this device is minimum 5fr.The sheath used by the customer was returned for analysis.There was damage noted on the tip of the sheath.A visual examination identified that the balloon was not folded which indicates that the balloon was subjected to positive pressure.A full balloon circumferential tear was identified located approximately 40mm distal of the proximal balloon bond.The distal section of the balloon material had been pulled distally towards the tip of the device.A visual examination observed no damage to the tip of the device.A visual and tactile examination found that there was a break in the shaft 1380mm proximal from the distal tip.The hub was detached and not returned with the device.The distal markerband had moved in a proximal direction due to the stretching of the shaft.This concludes the product 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 ; 4100 hamline ave n; arden hills, MN 55112 ; 6515810888
• MDR Report Key: 14698002
• Report Number: 2134265-2022-06232
• Device Sequence Number: 5326975
• Product Code: FGE
• UDI-Device Identifier: 08714729793953
• UDI-Public: 08714729793953
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• 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
• Report Date (Section B): 07/19/2022

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: 09/02/2023
• Device Model Number: 24674
• Device Catalogue Number: 24674
• Device Lot Number: 0025955297
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 05/23/2022
• Supplement Date Received by Manufacturer: 06/28/2022
• Initial Report FDA Received Date: 06/15/2022
• Supplement Report FDA Received Date: 07/19/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/02/2020
• 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
• Concomitant Medical Products and Therapy/Usage Dates: GUIDEWIRE: EXTRA STIFF; GUIDEWIRE: EXTRA STIFF; INTRODUCER SHEATH:MEDIKIT 7FR; INTRODUCER SHEATH:MEDIKIT 7FR
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown