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

Model Number	24673
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/03/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that tip detachment occurred requiring additional intervention.The 75% stenosed target lesion was located in the severely tortuous and non-calcified radial arteriovenous fistula.A 7.0 x 200, 75cm mustang balloon catheter was advanced for dilatation.However, during the procedure, it was noted that the catheter tip broke inside the patient's body.The device was completely removed from the patient's body via snaring and the procedure was completed with another of the same device.No complications were reported, and patient was stable post procedure.
Additional Manufacturer Narrative
Device was returned for evaluation.The recommended introducer/guide sheath size for this device is minimum 5fr.A visual examination identified that the balloon was not folded which indicates that the balloon was subjected to positive pressure.A complete balloon circumferential tear was identified located approximately 40mm distal of the proximal balloon sleeve.A visual and tactile examination found the shaft of the device to have separated approximately 40mm distal of the balloon circumferential tear.A visual examination found no issues with the markerbands of the device.A visual and tactile examination found no issues or damage to the tip 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 detachment occurred requiring additional intervention.The 75% stenosed target lesion was located in the severely tortuous and non-calcified radial arteriovenous fistula.A 7.0 x 200, 75cm mustang balloon catheter was advanced for dilatation.However, during the procedure, it was noted that the catheter tip broke inside the patient's body.The device was completely removed from the patient's body via snaring and the procedure was completed with another of the same device.No complications were reported, and 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: 19620731
• Report Number: 2124215-2024-36503
• Device Sequence Number: 8486006
• Product Code: LIT
• UDI-Device Identifier: 08714729794189
• UDI-Public: 08714729794189
• 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): 08/28/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: 24673
• Device Catalogue Number: 24673
• Device Lot Number: 0033371348
• 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: 06/04/2024
• Supplement Date Received by Manufacturer: 08/06/2024
• Initial Report FDA Received Date: 06/26/2024
• Supplement Report FDA Received Date: 08/28/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/07/2024
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 72 YR
• Patient Sex: Female