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

Model Number 45027

Device Problem Device Difficult to Setup or Prepare (1487)

Patient Problem No Patient Involvement (2645)

Event Date 05/01/2019

Event Type  malfunction  

Manufacturer Narrative

Device evaluation by mfr: the returned product consisted of a zelantedvt thrombectomy system.The pump, effluent/supply line, shaft, tip, piston, and spike line were visually inspected.Functional testing was performed.The complaint device failed to prime and an error message displayed on the console, meaning that the device over-pressured.The shaft and tip of the devicewere cut and the jet body was microscopically inspected.It was revealed that a jet was plugged with rust/saline, causing the over pressure as the flow was being restricted.Inspection of the remainder of the device revealed no other damage or irregularities.

Event Description

Reportable based on analysis completed 08jun2019.It was reported that the device was unable to prime.An angiojet zelante dvt catheter was selected for a thrombectomy procedure.During preparation the device was unable to prime.It never entered the patient's body.The patient was held overnight for further treatment with tissue plasminogen activator.The next day, the physician completed the procedure with a new angiojet zelante dvt device.The patient experience no complications and is fine.However, device analysis revealed the jet hole was plugged with rust.

• 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; two scimed place; maple grove MN 55311
• Manufacturer Contact: jay johnson ; two scimed place; maple grove, MN 55311 ; 7634942574
• MDR Report Key: 8695840
• MDR Text Key: 147895252
• Report Number: 2134265-2019-06687
• Device Sequence Number: 1
• Product Code: KRA
• UDI-Device Identifier: 08714729904724
• UDI-Public: 08714729904724
• 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: 06/13/2019

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 Expiration Date: 02/10/2021
• Device Model Number: 45027
• Device Catalogue Number: 45027
• Device Lot Number: 0023411951
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/29/2019
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 06/08/2019
• Initial Date FDA Received: 06/13/2019
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/11/2019
• 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