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 07/14/2019

Event Type  malfunction  

Manufacturer Narrative

Age at the time of event: less than 30 years old.Device evaluated by mfr.: the device was returned for evaluation.The pump, effluent/supply line, shaft, tip, piston, and spike line were visually inspected.Blood was present inside the device and the attached waste bag.The boot was half filled with, when received.Visual inspection revealed that there was a kink in the catheter shaft 18cm from the strain relief and that the transition between the proximal and distal outer shafts were separated (10.5cm proximal of the tip) with the inner lumen and hypotube kinked in the same location.The separated ends of the shaft detachment were jagged, indicating that there was force applied before the separation.Functional testing was performed by placing the device in the angiojet ultra console.The device would not go into prime and the boot filled with fluid and the check saline supply error was displayed on the console.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 supply line was kinked before separation.Inspection of the remainder of the device presented no other damage or irregularities.

Event Description

Reportable based on device analysis completed (b)(6) 2019.It was reported that an error message occurred.The target lesion was located in the left iliac vein.A zelante dvt thrombectomy catheter was selected for use.During the procedure, a "check saline supply" error was noted and the system shutdown in the middle of the procedure.The procedure was completed with another of the same device.No patient complications were reported and the patient's condition was fine.However, device analysis observed a catheter shaft 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 SCIMED, INC; two scimed place; maple grove MN 55311
• Manufacturer Contact: jay johnson ; two scimed place; maple grove, MN 55311 ; 7634942574
• MDR Report Key: 8940050
• MDR Text Key: 155950550
• Report Number: 2134265-2019-10362
• 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: 08/28/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/28/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 01/06/2021
• Device Model Number: 45027
• Device Catalogue Number: 45027
• Device Lot Number: 0023254936
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/24/2019
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 07/31/2019
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/07/2019
• 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