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

Model Number 45027

Device Problem Display or Visual Feedback Problem (1184)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 12/01/2019

Event Type  malfunction  

Manufacturer Narrative

Date of event: used the first day of the month of the aware date as no exact date provided.Device evaluated by mfr.: returned product consisted of the catheter portion of the zelantedvt thrombectomy system.The effluent and supply lines were cut-off at the hub and the effluent/supply lines, and the pump assembly were not returned for analysis.The shaft and tip were microscopically and visually inspected.Blood was present outside and inside the device, when received.Inspection of the device revealed that the transition between the proximal and outer shafts was separated (10.5cm proximal of the tip).The separated ends were jagged, indicating that there was force applied before the separation.The hypotube from the proximal and outer shaft transition to the proximal marker band was twisted with the hypotube detached from the jet body.The shaft was buckled at the distal window and markerband.The proximal markerband and shaft were cut to check the proximal saddle and hypotube at the saddle.When the shaft was removed and the hypotube and saddle inspected, there was no damage or irregularities.Functional testing could not be performed, as the catheter was cut-off from the proximal portion of the device with the pump assembly; however, it is known that when the hypotube is detached the device will not prime and the console will continue to try and prime the catheter, causing the "check saline supply" error to display on the console.

Event Description

Reportable based on device analysis completed on 20dec2019.It was reported that an error message occurred.An angiojet zelantedvt was advanced for a thrombectomy procedure.However, it was noted that an error message occurred.No patient complications were reported.However, returned device analysis revealed a hypotube detached/separated.

• 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: 9545332
• MDR Text Key: 177357458
• Report Number: 2134265-2019-16358
• 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: 01/03/2020

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 Expiration Date: 09/24/2021
• Device Model Number: 45027
• Device Catalogue Number: 45027
• Device Lot Number: 0024638385
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/16/2019
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 12/20/2019
• Initial Date FDA Received: 01/03/2020
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/25/2019
• 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