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

Model Number	24673
Medical Device Problem Codes	Material Rupture (1546); Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/01/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the balloon was ruptured.The 100% stenosed target lesion was located in the severely calcified and severely tortuous arteriovenous fistula.A 6.0 x 200, 135cm mustang balloon catheter was advanced for dilatation.During the procedure, the balloon was burst.The device was removed without any problem, and the procedure was completed with another of the same device.There were no patient complications reported, and the patient was in good condition after the procedure.
Additional Manufacturer Narrative
Device evaluated by mfr: the device was returned for analysis.A visual examination identified that the balloon was not folded, which indicates that the device was subjected to positive pressure.A leak test was carried out and the balloon was inflated to its rated burst pressure for 30 seconds using deionizes water and digital timer, without issue.A vacuum was then applied.The inflation device was verified at 22 atmospheres, before and after use with calibrated pressure gauge.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.As per specification, the rated burst pressure for this device is 22 atmospheres.No issues were noted with the tip of the device.A visual examination found no issue with the markerbands.Visual and tactile examination found that the shaft had stretching damage at more than one location.This type of damage is consistent with excessive tensile force being applied to the device.
Event or Problem Description
It was reported that the balloon was ruptured.The 100% stenosed target lesion was located in the severely calcified and severely tortuous arteriovenous fistula.A 6.0 x 200, 135cm mustang balloon catheter was advanced for dilatation.During the procedure, the balloon was burst.The device was removed without any problem, and the procedure was completed with another of the same device.There were no patient complications reported, and the patient was in good condition after the procedure.

• Brand Name: MUSTANG
• Common Device Name: CATHETER, BILIARY, DIAGNOSTIC
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 300 boston scientific way; marlborough MA 01752
• Manufacturer (Section G): BOSTON SCIENTIFIC CORPORATION; pmt 741 persiaran cassia selat; bandarcassia, pulau pinan 14110 ; MY 14110
• Manufacturer Contact: rachel shields ; 4100 hamline ave n; arden hills, MN 55112 ; 6512422111
• MDR Report Key: 19125223
• Report Number: 2124215-2024-22785
• Device Sequence Number: 18213675
• Product Code: LIT
• UDI-Device Identifier: 08714729793380
• UDI-Public: 08714729793380
• Combination Product (Y/N): N
• Initial Reporter Country: KS
• PMA/510(K) Number: K103751
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Health Professional,Company Representative,Distributor
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 06/05/2024

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: 10/01/2026
• Device Model Number: 24673
• Device Catalogue Number: 24673
• Device Lot Number: 0032542439
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 04/01/2024
• Supplement Date Received by Manufacturer: 05/16/2024
• Initial Report FDA Received Date: 04/17/2024
• Supplement Report FDA Received Date: 06/05/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/02/2023
• 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: 74 YR
• Patient Sex: Male