MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION SPIROFLEX ANGIOJET THROMBECTOMY SET; CATHETER, EMBOLECTOMY

Model Number 10706

Device Problems Leak/Splash (1354); Device Difficult to Setup or Prepare (1487); Device Displays Incorrect Message (2591)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 03/21/2019

Event Type  malfunction  

Event Description

It was reported that an error message occurred.A spiroflex angiojet thrombectomy set was selected for a thrombectomy procedure in the right coronary artery.During priming, the device stopped working for one second and then started normally.The device ran about one minute under thrombectomy mode when the system displayed the saline was filled error.The system was reset however, the machine still did not work and prompted to replace the catheter.It was also reported that there was some liquid under the pump.The procedure was completed with another of the same device.No patient complications were reported and patient's status is stable.

Manufacturer Narrative

Device evaluated by mfr.: returned product consisted of the spiroflex thrombectomy system.The pump, effluent/supply line, shaft, tip, piston, and spike line were visually inspected.When received there was blood present inside the device.The waste bag was cut-off and not returned for analysis.Inspection of the device revealed that the shaft was twisted causing a perforation 2cm-3.5cm proximal of the tip.In the same location the wire lumen and hypotube were also twisted.However, there was no damage to the boot or pump assembly.Functional testing was performed by placing the device in the angiojet ultra console.Testing consisted of running the complaint device through the full priming cycle and 120 seconds in thrombectomy.The device ran within normal range (8.15 kpsi), without any leaks from the boot or pump assembly or anywhere else on the device and there were no console errors/alarms.Product analysis did not confirm the reported event, as there were no leaks from the device and the device ran with no issues.

Event Description

It was reported that an error message occurred.A spiroflex angiojet thrombectomy set was selected for a thrombectomy procedure in the right coronary artery.During priming, the device stopped working for one second and then started normally.The device ran about one minute under thrombectomy mode when the system displayed the saline was filled error.The system was reset however, the machine still did not work and prompted to replace the catheter.It was also reported that there was some liquid under the pump.The procedure was completed with another of the same device.No patient complications were reported and patient's status is stable.

• Brand Name: SPIROFLEX ANGIOJET THROMBECTOMY SET
• Type of Device: CATHETER, EMBOLECTOMY
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; two scimed place; maple grove MN 55311
• MDR Report Key: 9180541
• MDR Text Key: 163158947
• Report Number: 2134265-2019-12270
• Device Sequence Number: 1
• Product Code: DXE
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,distri
• Type of Report: Initial,Followup
• Report Date: 11/15/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/11/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 08/31/2019
• Device Model Number: 10706
• Device Catalogue Number: 10706
• Device Lot Number: 0021263702
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/28/2019
• Date Manufacturer Received: 11/04/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 81 YR
• Patient Weight: 54