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

Model Number 45027

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Perforation (2001); Blood Loss (2597)

Event Date 10/27/2020

Event Type  Injury  

Manufacturer Narrative

(b)(6).Age at time of event: 18 years or older.

Event Description

It was reported that a perforation occurred and the patient had bleeding.The target lesion was located in the iliac vein.An angiojet zelantedvt was selected for a thrombectomy procedure.During the procedure, it was noted that the vessel ruptured after doing thrombectomy for about 50 seconds.Then the procedure was stopped.The device was completely removed from the patient's body and the physician used his hands for about 10 minutes to stop the bleeding.Bleeding was successfully stopped and procedure was completed.The patient had bleeding tendency before the procedure.No further patient complications were reported and the patient's status was stable.

• 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 CORPORATION; 500 commander shea boulevard; quincy MA 02171
• Manufacturer Contact: jay johnson ; two scimed place; maple grove, MN 55311 ; 7634942574
• MDR Report Key: 10801888
• MDR Text Key: 215071217
• Report Number: 2134265-2020-15377
• Device Sequence Number: 1
• Product Code: DXE
• Combination Product (y/n): N
• Reporter Country Code: KS
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,distri
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 11/06/2020

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
• Device Operator: Health Professional
• Device Expiration Date: 08/11/2022
• Device Model Number: 45027
• Device Catalogue Number: 45027
• Device Lot Number: 0025949530
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 10/27/2020
• Initial Date FDA Received: 11/06/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/11/2020
• 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 Outcome(s): Other