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); Pumping Problem (3016)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 04/27/2020

Event Type  malfunction  

Manufacturer Narrative

Device evaluated by mfr.: returned product consisted of portion of the solent omni thrombectomy system.Only 63cm of the proximal portion of the catheter was returned for analysis.The distal end with the markerbands, jet body, and tip were not returned for analysis.The pump assembly, effluent/supply line, shaft, and spike line were microscopically and visually inspected.Inspection of the device revealed that the proximal shaft and hypotube were detached 63cm distal of the strain relief.The appearance of the proximal shaft was jagged and the separated end of the hypotube was ovaled, indicating that both were kinked prior to separation.Functional testing was not performed as the shaft and hypotube were detached and the distal end of the catheter was not returned for analysis.Although the device was not tested, it is known that when the hypotube is separated or broken, 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 with the device not able to prime causing the boot to fill with fluid.

Event Description

Reportable based on device analysis completed on 20-july-2020.It was reported that an error message was displayed.The target lesion was located in the left common iliac vein.An angiojet solent omni catheter was used for a thrombectomy procedure.During the procedure, the system prompted check saline supply error when worked for 35 seconds under power pulse mode.There was liquid noted in the pump and collection bag.The console was reset, but the catheter could not continue to prime pass 12 seconds.The procedure was completed with another of the same device.No patient complications were reported and patient's status was stable.However, returned device analysis revealed a hypotube break.

• 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 CORPORATION; 500 commander shea boulevard; quincy MA 02171
• Manufacturer Contact: jay johnson ; two scimed place; maple grove, MN 55311 ; 7634942574
• MDR Report Key: 10358109
• MDR Text Key: 201733213
• Report Number: 2134265-2020-10313
• 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: 08/03/2020

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: 10/13/2021
• Device Model Number: 45031
• Device Catalogue Number: 45031
• Device Lot Number: 0024939827
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/11/2020
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 07/20/2020
• Initial Date FDA Received: 08/03/2020
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/14/2019
• 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: 57 YR
• Patient Weight: 52