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

Model Number	24674
Medical Device Problem Codes	Inflation Problem (1310); Leak/Splash (1354); Material Integrity Problem (2978)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/13/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
E1 - initial reporter facility name: (b)(6).
Event or Problem Description
It was reported that tip break occurred.The severely stenosed target lesion was located in the moderately tortuous and moderately calcified left femoral artery.An 8.0 x 80, 135cm mustang balloon catheter was advanced for post dilatation.When the balloon reached the lesion site, the balloon was inflated once at 5-6 atmospheres.However, the balloon could not be inflated and was leaking contrast.The balloon was withdrawn, and it was found that the very tip of the balloon was broken and leaking liquid.The procedure was completed with another of same device.No complications were reported, and the patient was stable post procedure.
Additional Manufacturer Narrative
E1 - initial reporter facility name: (b)(6).Device was returned for evaluation.A visual examination identified that the balloon was not subjected to positive pressure.A leak test was carried out using de-ionized water when liquid was observed to be exiting from the tip of the device.An examination of the balloon material identified no issues.A visual examination observed no issues or damage to the tip of the device.A visual and tactile examination found no kinks to the shaft of the device.A leak test identified liquid exiting the tip of the device which is an indication of a breach between the wire lumen and the inflation lumen.It is not possible to identify the exact location of the lumen breach.No other issues were identified with the shaft.A visual examination observed no issues with the markerbands of the device.Both markerbands were undamaged and in the correct position on the shaft of the device.No other issues were identified with the device and no patient complications were reported.
Event or Problem Description
It was reported that tip break occurred.The severely stenosed target lesion was located in the moderately tortuous and moderately calcified left femoral artery.An 8.0 x 80, 135cm mustang balloon catheter was advanced for post dilatation.When the balloon reached the lesion site, the balloon was inflated once at 5-6 atmospheres.However, the balloon could not be inflated and was leaking contrast.The balloon was withdrawn, and it was found that the very tip of the balloon was broken and leaking liquid.The procedure was completed with another of same device.No complications were reported, and the patient was stable post 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: 19704520
• Report Number: 2124215-2024-39716
• Device Sequence Number: 3701581
• Product Code: FGE
• UDI-Device Identifier: 08714729794301
• UDI-Public: 08714729794301
• 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: Other,Foreign,Health Professional,Company Representative,Distributor
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 09/09/2024

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: 01/31/2026
• Device Model Number: 24674
• Device Catalogue Number: 24674
• Device Lot Number: 0030955045
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/13/2024
• Supplement Date Received by Manufacturer: 08/14/2024
• Initial Report FDA Received Date: 07/09/2024
• Supplement Report FDA Received Date: 09/09/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/01/2023
• 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: 68 YR
• Patient Sex: Male
• Patient Weight: 75 KG