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

Model Number 45027

Device Problem Device Displays Incorrect Message (2591)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 06/11/2020

Event Type  malfunction  

Manufacturer Narrative

Age of time of event: 18yrs below.Device evaluated by mfr.: returned product consisted of a zelantedvt thrombectomy system.The pump assembly, effluent/supply line, shaft, hypotube, tip, and spike line were visually inspected.Blood was present inside the device and the waste bag was cut-off and not returned for analysis.Inspection of the device revealed that the hypotube was twisted from the hub distally to the proximal markerband.Functional testing was started but the 'onnect saline supply' error was displayed on the console and the device would not prime with fluid filling the boot.The proximal markerband and shaft were cut-off to examine the proximal saddle.There was no damage to the saddle, as it was still intact and attached to the hypotube.But with shaft cut, the hypotube moved and it was revealed through microscopic examination that the hypotube was detached at the jet body.The separated ends of the hypotube appeared to be ovaled, indicating that the hypotube was compressed before separation.It was most likely that the shaft was turned around consistently causing the hypotube to be twisted and eventually break due to the force at the jet body, when the hypotube is separated, the device will not prime and the console will continue to try and prime the catheter, causing the 'connect or check saline supply' error to display on the console and the boot to fill with fluid.

Event Description

Reportable based on device analysis completed on 29-july-2020.It was reported that an error message occurred.An angiojet zelantedvt catheter was used for a thrombectomy procedure.During the procedure, the device was used for 300 seconds and then system prompted check saline supply error.The procedure was completed with another of the same device.No patient complications were reported and patient's status was stable.However, device analysis revealed a hypotube break.

• 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: 10396357
• MDR Text Key: 202568186
• Report Number: 2134265-2020-10918
• Device Sequence Number: 1
• Product Code: DXE
• Combination Product (y/n): N
• Reporter Country Code: TW
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 08/12/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/12/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 11/25/2021
• Device Model Number: 45027
• Device Catalogue Number: 45027
• Device Lot Number: 0024964270
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/26/2020
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 07/29/2020
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/26/2019
• 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