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

Model Number	24672
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/18/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
E1: initial reporter address 1: (b)(6).E1: initial reporter phone number: (b)(6).
Event or Problem Description
It was reported that shaft break occurred.During unpacking of a 6.0 x 150, 135cm mustang balloon catheter, it was noticed that the balloon and the shaft was completely separated into two pieces at about 120cm from the hub.The procedure was completed with another of the same device.There were no patient complications reported and the patient was stable.
Event or Problem Description
It was reported that shaft break occurred.During unpacking of a 6.0 x 150, 135cm mustang balloon catheter, it was noticed that the balloon and the shaft was completely separated into two pieces at about 120cm from the hub.The procedure was completed with another of the same device.There were no patient complications reported and the patient was stable.
Additional Manufacturer Narrative
D4 - lot number: updated from 29613528 to 29184873.Device evaluation by mfr: a mustang device was returned for analysis.A visual examination identified that the balloon was not subjected to positive pressure and the markerbands was still attached to the balloon section of the device.The rated burst pressure for this device as per mustang specification is 22 atmospheres.A visual examination observed no damage to the tip of the device.A visual and tactile examination found the shaft of the device to have completely detached.The break was located approximately 175mm proximal of the distal tip.Stretching damage was noted for approximately 6mm proximal from where the shaft was detached.A visual examination found no issues with the markerbands.This concludes the product analysis.(b)(6).

• 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: jeff wallner ; 4100 hamline ave n; arden hills, MN 55112 ; 6515811560
• MDR Report Key: 16824892
• Report Number: 2124215-2023-19752
• Device Sequence Number: 7014477
• Product Code: LIT
• UDI-Device Identifier: 08714729793458
• UDI-Public: 08714729793458
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• 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: Foreign,Health Professional,Company Representative,Distributor
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 06/01/2023

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: 24672
• Device Catalogue Number: 24672
• Device Lot Number: 0029184873
• 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: 04/19/2023
• Supplement Date Received by Manufacturer: 05/22/2023
• Initial Report FDA Received Date: 04/27/2023
• Supplement Report FDA Received Date: 06/01/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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: 62 YR
• Patient Sex: Male
• Patient Weight: 70 KG