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	10/21/2022
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that balloon rupture occurred.The stenosed target lesion was located in the inferior vena cava vein.A 10.0 x 60, 135cm mustang balloon catheter was advanced for post-dilatation.However, the balloon ruptured when using another device.The procedure was completed with another of the same device.There were no complications reported and the patient was stable.
Event or Problem Description
It was reported that balloon rupture occurred.The stenosed target lesion was located in the inferior vena cava vein.A 10.0 x 60, 135cm mustang balloon catheter was advanced for post-dilatation.However, the balloon ruptured when using another device.The procedure was completed with another of the same device.There were no complications reported and the patient was stable.It was further reported that lesion was 60% stenosed, moderately tortuous, and severely calcified.Two of the same balloons were used in the procedure.However, during the initial inflation at 8 atmospheres for 5 seconds, the balloons ruptured.
Event or Problem Description
It was reported that balloon rupture occurred.The stenosed target lesion was located in the inferior vena cava vein.A 10.0 x 60, 135cm mustang balloon catheter was advanced for post-dilatation.However, the balloon ruptured when using another device.The procedure was completed with another of the same device.There were no complications reported and the patient was stable.It was further reported that lesion was 60% stenosed, moderately tortuous, and severely calcified.Two of the same balloons were used in the procedure.However, during the initial inflation at 8 atmospheres for 5 seconds, the balloons ruptured.
Additional Manufacturer Narrative
Updated (d4) lot number to 29185049.Device evaluated by mfr.: mustang 10.0 x 60, 135cm was received for analysis.A visual examination identified that the balloon was not folded which indicates that it was subjected to positive pressure.A partial balloon circumferential tear was identified located approximately 14mm distal of the distal markerband.From the partial circumferential tear, the balloon was also torn longitudinally for approximately 77mm proximally.An examination of the balloon material and markerbands identified no issues which could potentially have contributed to this complaint.A visual 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.

• 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: 15676682
• Report Number: 2124215-2022-43776
• Device Sequence Number: 20444028
• Product Code: FGE
• UDI-Device Identifier: 08714729795230
• UDI-Public: 08714729795230
• 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): 12/16/2022

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: 04/06/2025
• Device Model Number: 24674
• Device Catalogue Number: 24674
• Device Lot Number: 0029185049
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 10/21/2022
• Supplement Date Received by Manufacturer: 10/27/2022; 11/30/2022
• Initial Report FDA Received Date: 10/26/2022
• Supplement Report FDA Received Date: 11/09/2022; 12/16/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 04/07/2022
• 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: 60 YR
• Patient Sex: Male
• Patient Weight: 60 KG