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

Model Number	114610-001
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Renal Failure (2041)
Date of Event	04/23/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that patient went into renal failure post-procedure and had to be taken to the hospital.An angiojet zelantedvt was selected for use in a thrombectomy procedure.The device was successfully used during the procedure without any complications.Post procedure, it was noted that the patient's creatinine level which was highly elevated and went into renal failure.The patient was taken to the hospital for further treatment and evaluation.
Additional Manufacturer Narrative
D2b - pro code (product code): dxe, kra.Detailed product, event and patient information was not provided to bsc.We completed a good faith effort to obtain the information, but it was unable to be obtained.Because the product is unknown, we are unable to provide the unique identifier (udi) and other specific product information.If additional details become available, a supplemental report will be submitted.

• 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: mark mischke ; 4100 hamline ave n; arden hills, MN 55112 ; 7634941632
• MDR Report Key: 25243055
• Report Number: 2124215-2026-27424
• Device Sequence Number: 10547992
• Product Code: DXE
• UDI-Device Identifier: 08714729904724
• UDI-Public: (01)08714729904724
• Combination Product (Y/N): N
• Initial Reporter State: FL
• 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
• Report Date (Section B): 05/21/2026

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?: No
• Operator of Device: Health Professional
• Device Model Number: 114610-001
• Device Catalogue Number: 114610-001
• 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: 04/27/2026
• Initial Report FDA Received Date: 05/21/2026
• 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: Hospitalization
• Patient Sex: Unknown