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	12/17/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(6).
Event or Problem Description
It was reported that balloon rupture occurred.The patient underwent internal fistuloplasty.The long section stenosis target lesion was located in the axillary artery.The patient was noted with long-term treatment of hemodialysis, and was treated under digital subtraction angiography (dsa).The physician punctured with sheath and placed non-boston scientific (bsc) catheter along with a non-bsc guide wire were crossed the lesion.Subsequently, a 5.0 x 100, 135cm mustang balloon catheter was advanced for dilatation.However, during the first inflation at less working pressure, the balloon ruptured.The device was removed and the procedure was completed with another of same device.There were no patient complications reported and the patient status was stable.
Event or Problem Description
It was reported that balloon rupture occurred.The patient underwent internal fistuloplasty.The long section stenosis target lesion was located in the axillary artery.The patient was noted with long-term treatment of hemodialysis, and was treated under digital subtraction angiography (dsa).The physician punctured with sheath and placed non-boston scientific (bsc) catheter along with a non-bsc guide wire were crossed the lesion.Subsequently, a 5.0 x 100, 135cm mustang balloon catheter was advanced for dilatation.However, during the first inflation at less working pressure, the balloon ruptured.The device was removed and the procedure was completed with another of same device.There were no patient complications reported and the patient status was stable.
Additional Manufacturer Narrative
E1-initial reporter facility name: (b)(6).Device evaluated by mfr.: a mustang device was returned for analysis.A visual examination identified that the balloon was not folded, and inflation media was present inside it which indicates that the balloon was subjected to positive pressure.The returned device was attached to an encore inflation unit and positive pressure was applied, the balloon was inflated to its rate of burst pressure for 30 seconds without issue.A vacuum was then applied.The inflation device was verified at 24 atmospheres, before and after use with calibrated pressure.This inflation to rate of burst pressure was repeated three times with no leaks or drop in pressure noted.No issues were identified with balloon inflation or the balloon material.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 identified no kinks or damage to the shaft which may have potentially contributed to the complaint incident.A visual and tactile examination identified no damage to the tip which may have potentially contributed to the complaint incident.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; ballybrit business park; galway ; EI
• Manufacturer Contact: jay johnson ; two scimed place; maple grove, MN 55311 ; 7634942574
• MDR Report Key: 13216236
• Report Number: 2134265-2021-16640
• Device Sequence Number: 20314851
• Product Code: FGE
• UDI-Device Identifier: 08714729793533
• UDI-Public: 08714729793533
• 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
• Report Date (Section B): 02/01/2022

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: 04/07/2024
• Device Model Number: 24674
• Device Catalogue Number: 24674
• Device Lot Number: 0027104949
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/18/2022
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 12/21/2021
• Supplement Date Received by Manufacturer: 01/28/2022
• Initial Report FDA Received Date: 01/11/2022
• Supplement Report FDA Received Date: 02/01/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/08/2021
• 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
• Patient Age: 45 YR
• Patient Sex: Male