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

Model Number	24672
Medical Device Problem Code	Entrapment of Device (1212)
Health Effect - Clinical Codes	No Consequences Or Impact To Patient (2199); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/19/2020
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that catheter entrapment occurred.The 50-60% stenosed target lesion was located in the non-tortuous and moderately calcified superficial femoral artery.A 6.0 x 150, 135cm mustang balloon catheter was advanced for dilation.However, after deflation, the balloon refused to exit and became stuck over the wire.The device was removed with the whole system and completed the procedure with another of same device.There were no patient complications reported and the patient was stable.
Additional Manufacturer Narrative
Device evaluated by mfr.: mustang device 6x15x135cm was received for analysis.As per the mustang direction for use the catheter is compatible with a 0.035in (0.89 mm) guidewire.The investigator successfully loaded a boston scientific 0.035in guidewire through the mustang device and removed it with no resistance encountered.No issues were identified with the device that could potentially have contributed to the complaint incident.A visual and tactile examination identified that the balloon had been subject to positive pressure.No damage or issues were noted which may have potentially contributed to the complaint incident.A visual and tactile examination identified no issues with the shaft of the device.No issues were identified during the product analysis.
Event or Problem Description
It was reported that catheter entrapment occurred.The 50-60% stenosed target lesion was located in the non-tortuous and moderately calcified superficial femoral artery.A 6.0 x 150, 135cm mustang balloon catheter was advanced for dilation.However, after deflation, the balloon refused to exit and became stuck over the wire.The device was removed with the whole system and completed the procedure with another of same device.There were no patient complications reported and the patient was stable.

• Brand Name: MUSTANG
• Common Device Name: CATHETER, BILIARY, DIAGNOSTIC
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; two scimed place; maple grove MN 55311
• MDR Report Key: 10793205
• Report Number: 2134265-2020-15180
• Device Sequence Number: 11044130
• Product Code: LIT
• UDI-Device Identifier: 08714729793458
• UDI-Public: 08714729793458
• Combination Product (Y/N): N
• Initial Reporter Country: EG
• 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: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 04/29/2021

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: 02/07/2022
• Device Model Number: 24672
• Device Catalogue Number: 24672
• Device Lot Number: 0023318269
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/23/2021
• Initial Date Received by Manufacturer: 10/19/2020
• Supplement Date Received by Manufacturer: 04/09/2021
• Initial Report FDA Received Date: 11/05/2020
• Supplement Report FDA Received Date: 04/29/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 50 YR
• Patient Weight: 80