MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION ANGIOJET AVX; CATHETER, EMBOLECTOMY

Model Number	105039-001
Medical Device Problem Codes	Difficult to Remove (1528); Material Deformation (2976)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/01/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported via medwatch # (b)(4) that the catheter became stuck in sheath.A 6f x 50 cm angiojet avx catheter was selected for thrombectomy procedure.However, the catheter became stuck in the 6f sheath.Subsequently, the thrombectomy part of the catheter accordion, and not allowing the catheter to be easily removed.No complications were reported.
Additional Manufacturer Narrative
H10: added medwatch number.
Event or Problem Description
It was reported via medwatch (b)(4) that the catheter became stuck in sheath.A 6f x 50cm angiojet avx catheter was selected for thrombectomy procedure.However, the catheter became stuck in the 6f sheath.Subsequently, the thrombectomy part of the catheter accordioned, and not allowing the catheter to be easily removed.No complications were reported.

• Brand Name: ANGIOJET AVX
• Common Device Name: CATHETER, EMBOLECTOMY
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 300 boston scientific way; marlborough MA 01752
• Manufacturer (Section G): BOSTON SCIENTIFIC CORPORATION; road 698, lot no. 12; dorado PR 00646 -260; * 00646-2602
• Manufacturer Contact: rachel shields ; 4100 hamline ave n; arden hills, MN 55112 ; 6512422111
• MDR Report Key: 21563586
• Report Number: 2124215-2025-12685
• Device Sequence Number: 15853438
• Product Code: DXE
• UDI-Device Identifier: 08714729889045
• UDI-Public: 08714729889045
• Combination Product (Y/N): N
• Initial Reporter State: MN
• Initial Reporter Country: US
• PMA/510(K) Number: K133629
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 03/24/2025

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: 05/28/2026
• Device Model Number: 105039-001
• Device Catalogue Number: 105039-001
• Device Lot Number: 0034787726
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/13/2025
• Supplement Date Received by Manufacturer: 03/19/2025
• Initial Report FDA Received Date: 03/10/2025
• Supplement Report FDA Received Date: 03/24/2025
• Date Device Manufactured: 06/28/2024
• 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
• Patient Sex: Unknown