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

Model Number	24674
Medical Device Problem Codes	Unsealed Device Packaging (1444); Packaging Problem (3007)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/22/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that device contamination occurred.A 6.0 x 60, 135cm mustang balloon was selected for use.However, it was noted that the packaging box was crumpled as if it had been folded in half.Consequently, the sterility of the balloon catheter was most likely compromised.No patient complications were reported.
Event or Problem Description
It was reported that device contamination occurred.A 6.0 x 60, 135cm mustang balloon was selected for use.However, it was noted that the packaging box was crumpled as if it had been folded in half.Consequently, the sterility of the balloon catheter was most likely compromised.No patient complications were reported.
Additional Manufacturer Narrative
Device evaluated by mfr: the complaint device was received for product analysis.A visual examination of the outer box carton found that the blue tear strip seal and the box carton had been opened.The box carton was also noted to be damaged.A visual examination of the inner pouch device found the inner pouch to have been opened, compromising the sterility of the device inside.A visual examination of the protective hoop found the device to be inside the protective hoop.The hoop was noted to be kinked at more than one location.For investigation purposes the device was removed from the protective hoop.A visual and tactile examination found the shaft of the device to be compressed/kinked at more than one location at the same location as the hoop when the device was inside it.No other issues were noted with the device.

• 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: 19986722
• Report Number: 2124215-2024-48969
• Device Sequence Number: 17949542
• Product Code: FGE
• UDI-Device Identifier: 08714729793939
• UDI-Public: 08714729793939
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• 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: Health Professional,Company Representative
• 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: 08/23/2026
• Device Model Number: 24674
• Device Catalogue Number: 24674
• Device Lot Number: 0032285024
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/12/2024
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/22/2024
• Supplement Date Received by Manufacturer: 08/20/2024
• Initial Report FDA Received Date: 08/14/2024
• Supplement Report FDA Received Date: 09/09/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/24/2023
• 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 Sex: Unknown