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

Model Number 45027

Device Problems Fracture (1260); Difficult to Remove (1528)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 02/24/2020

Event Type  malfunction  

Event Description

It was reported that catheter removal difficulty and shaft fracture occurred.The fully occluded target lesion was located in the left iliac vein to the left popliteal vein.An angiojet zelantedvt was advanced for a thrombectomy procedure.However, during procedure, the catheter was difficult to remove from the sheath as it was caught on the chronic thrombus.The device was pulled out through the sheath and no fragments were left inside the patient.After removal, it was noted that the window was larger than normal and was fractured.The procedure was completed with another of the same device.No patient complications were reported.

• Brand Name: ANGIOJET ZELANTEDVT
• Type of Device: CATHETER, EMBOLECTOMY
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; two scimed place; maple grove MN 55311
• Manufacturer (Section G): BOSTON SCIENTIFIC SCIMED, INC; 500 commander shea boulevard; quincy MA 02171
• Manufacturer Contact: jay johnson ; two scimed place; maple grove, MN 55311 ; 7634942574
• MDR Report Key: 9807208
• MDR Text Key: 182737856
• Report Number: 2134265-2020-02748
• Device Sequence Number: 1
• Product Code: KRA
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K151313
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 03/09/2020

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
• Device Operator: Health Professional
• Device Model Number: 45027
• Device Catalogue Number: 45027
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 02/24/2020
• Initial Date FDA Received: 03/09/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Age: 33 YR