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 03/18/2020

Event Type  malfunction  

Manufacturer Narrative

Device evaluated by mfr.: returned product consisted of a zelantedvt thrombectomy system.The pump, effluent/supply line, shaft, tip, piston, and spike line were visually and microscopically inspected.Inspection of the device revealed that the shaft was kinked 20cm distal of the strain relief.Microscopic examination of the hypotube at the location of the kink, revealed that the hypotube was broken.The separated ends of the hypotube were ovaled, indicating that the hypotube was kinked prior to the separation.Therefore; the shaft was kinked causing the hypotube to break, when the hypotube is broke, the device will not prime and the console will continue to try and prime the catheter, causing the console to error and not work.

Event Description

Reportable based on device analysis completed on 22-april-2020.It was reported that an error message was displayed.An angiojet zelantedvt was used for a thrombectomy procedure in the left leg.During start of procedure while putting in the tissue plasminogen activator (tpa), multiple errors requesting alarm to be reset occurred in power pulse mode.The procedure was completed with another of the same device.No patient complications were reported and the patient's status was fine.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: 10004611
• MDR Text Key: 189620924
• Report Number: 2134265-2020-05674
• 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: 04/28/2020

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: 01/21/2022
• Device Model Number: 45027
• Device Catalogue Number: 45027
• Device Lot Number: 0025163545
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/03/2020
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 04/22/2020
• Initial Date FDA Received: 04/28/2020
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/22/2020
• 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 Age: 44 YR