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

Model Number	24674
Medical Device Problem Code	Failure to Deflate (4060)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/18/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that balloon deflation occurred resulting in additional intervention.The target lesion was located in cephalic vein.An 8.0 x 60, 135cm mustang balloon catheter was advanced for dilation during the treatment of an arteriovenous fistula thrombosis for hemodialysis.However, during procedure the balloon failed to deflate.The maximum pressure has not been exceeded.The physician tried to use insufflator in conventional way to deflate the device and syringe thereafter but failed.The insufflator used was disconnected but the balloon remained full and with significant pressure.The balloon was punctured percutaneously and removed from the patient.The procedure was completed with this device.The patient was stable and there were no patient complications and injuries reported.
Additional Manufacturer Narrative
Device evaluated by mfr.: a mustang device was received for analysis.A visual examination identified that the balloon was not folded which indicates that the device was subjected to positive pressure.The returned device was attached to an encore inflation unit.Positive pressure was applied, and the balloon was inflated to its rate of burst pressure using glycerol/water and digital timer when liquid was observed to be leaking from a balloon pinhole located approximately 30 mm distal of the proximal markerband.An examination of the markerbands identified no issues.A visual examination observed no damage to the tip of the device.A visual and tactile examination of the shaft identified no issues.
Event or Problem Description
It was reported that balloon deflation occurred resulting in additional intervention.The target lesion was located in cephalic vein.An 8.0 x 60, 135cm mustang balloon catheter was advanced for dilation during the treatment of an arteriovenous fistula thrombosis for hemodialysis.However, during procedure the balloon failed to deflate.The maximum pressure has not been exceeded.The physician tried to use insufflator in conventional way to deflate the device and syringe thereafter but failed.The insufflator used was disconnected but the balloon remained full and with significant pressure.The balloon was punctured percutaneously and removed from the patient.The procedure was completed with this device.The patient was stable and there were no patient complications and injuries reported.

• 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 ; 4100 hamline ave n; arden hills, MN 55112 ; 6515810888
• MDR Report Key: 15756393
• Report Number: 2124215-2022-44668
• Device Sequence Number: 17811410
• Product Code: FGE
• UDI-Device Identifier: 08714729794714
• UDI-Public: 08714729794714
• Combination Product (Y/N): N
• Initial Reporter Country: BR
• 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): 02/13/2023

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: 10/03/2024
• Device Model Number: 24674
• Device Catalogue Number: 24674
• Device Lot Number: 0028133567
• 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: 10/21/2022
• Supplement Date Received by Manufacturer: 01/20/2023
• Initial Report FDA Received Date: 11/08/2022
• Supplement Report FDA Received Date: 02/13/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/04/2021
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 68 YR
• Patient Sex: Male