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

Model Number 45031

Device Problems Device Difficult to Setup or Prepare (1487); Device Displays Incorrect Message (2591)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 04/24/2019

Event Type  malfunction  

Manufacturer Narrative

Device evaluation by mfr: the returned product consisted of a solent omni thrombectomy system.The pump assembly, effluent/supply line, shaft, tip, piston, and spike line were visually inspected.Blood was present outside and inside the device.The boot had some fluid in it, when received.Visual and microscopic inspection of the device revealed that there were numerous kinks throughout the device.There was a hole in the shaft 39cm distal of the strain relief at a severe kink.Functional testing was performed.The complaint device failed to prime and the check saline supply error was displayed on the console and the boot filled with fluid.Microscopic examination of the device revealed that the hypotube was broken at the location of the kink.The appearance of the separated ends of the hypotube were ovaled, indicating the hypotube was kinked prior to separation.Inspection of the remainder of the device presented no other damage or irregularities.

Event Description

Reportable based off device analysis completed on 30may2019.It was reported that the device failed to prime, fluid filled in the pump and an error occurred.An angiojet solent omni catheter was selected for a thrombectomy procedure in right lower leg.During preparation, the device failed to prime after 12 seconds and displayed an error message.The physician reset the device, but the same event occurred.The procedure was stopped and liquid was noted inside the pump.The physician reset the device and was successfully able to prime the device.While the device was inside the patient, an error message on the system appeared.It suggested to check the pipes.The physician reset the device again, and the catheter primed for three seconds and the same system error appeared.The physician found liquid in the pump.The device was removed, and another solent omni was chosen to finish the procedure.The patient experienced no adverse effects and is fine.However, a broken hypotube was noted on a portion of the device that was inside the patient.

• Brand Name: ANGIOJET SOLENT OMNI
• 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 ; 6515827403
• MDR Report Key: 8675684
• MDR Text Key: 147229477
• Report Number: 2134265-2019-06427
• Device Sequence Number: 1
• Product Code: DXE
• Combination Product (y/n): N
• Reporter Country Code: CH
• PMA/PMN Number: K111182
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,distri
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 06/06/2019

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: 12/29/2020
• Device Model Number: 45031
• Device Catalogue Number: 45031
• Device Lot Number: 0023347101
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/21/2019
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 05/30/2019
• Initial Date FDA Received: 06/06/2019
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/30/2019
• 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
• Patient Age: 62 YR
• Patient Weight: 58