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

Model Number	114610-001
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/12/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
D2b - pro code (product code): kra.
Event or Problem Description
It was reported that tip break occurred.The angiojet zelantedvt was selected for use during the procedure.The physician performed a thrombectomy using a 12 fr sheath, with the smart claw catheter advanced over a 0.35 glide wire and the zelante catheter advanced over a second 0.35 glide wire.The smartclaw thrombectomy was performed according to protocol.The zelante catheter was removed first, followed by the smartclaw.Resistance was encountered during the removal of the zelante catheter, and upon inspection, it was noted that the catheter tip was broken, with the distal marker and tip detached.The physician successfully retrieved the broken fragment and performed an angiogram to confirm no residual pieces remained in the patient.The procedure was completed using an alternative device.No complications were reported, and the patient remained in good condition post-procedure.
Additional Manufacturer Narrative
D2b - pro code (product code): kra.
Event or Problem Description
It was reported that tip break occurred.The angiojet zelantedvt was selected for use during the procedure.The physician performed a thrombectomy using a 12 fr sheath, with the smart claw catheter advanced over a 0.35 glide wire and the zelante catheter advanced over a second 0.35 glide wire.The smartclaw thrombectomy was performed according to protocol.The zelante catheter was removed first, followed by the smartclaw.Resistance was encountered during the removal of the zelante catheter, and upon inspection, it was noted that the catheter tip was broken, with the distal marker and tip detached.The physician successfully retrieved the broken fragment and performed an angiogram to confirm no residual pieces remained in the patient.The procedure was completed using an alternative device.No complications were reported, and the patient remained in good condition post-procedure.It was further reported that the device broke at the distal tip, specifically at the distal marker band, while inside the patient.No error message appeared during the procedure, and the device and packaging were inspected before use without any visible damage.The thrombectomy therapy was aborted, and a catheter-directed thrombolysis (cdt) procedure was performed instead.The issue arose while attempting to remove the device inside the body, but no additional damage to the unit was observed.

• Brand Name: ANGIOJET ZELANTEDVT
• 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: 21574929
• Report Number: 2124215-2025-14952
• Device Sequence Number: 8225408
• Product Code: DXE
• UDI-Device Identifier: 08714729904724
• UDI-Public: 08714729904724
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Initial Reporter Country: US
• PMA/510(K) Number: K151313
• 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): 03/31/2025

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: 04/25/2026
• Device Model Number: 114610-001
• Device Catalogue Number: 114610-001
• Device Lot Number: 0034220429
• 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: 02/12/2025
• Supplement Date Received by Manufacturer: 03/08/2025
• Initial Report FDA Received Date: 03/11/2025
• Supplement Report FDA Received Date: 03/31/2025
• Date Device Manufactured: 04/25/2024
• 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: Female