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

Model Number 45031

Device Problems Display or Visual Feedback Problem (1184); Leak/Splash (1354); Defective Device (2588)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 10/11/2022

Event Type  malfunction  

Manufacturer Narrative

Device evaluated by mfr.: the device was returned for analysis.Returned product consisted of an angiojet solent omni catheter.The pump assembly, effluent/supply line.Shaft, tiip, and spike line were visually examined for damage or any irregularities.The catheter shaft showed multiple bends and kinks.Functional testing was attempted; however, the device would not prime.During analysis at the severely kinked location at 50 cm and 71 cm from the tip, the hypotube was broken and completely separated in two different locations in the shaft.The device could not be functionally tested due to the extreme damage on the device.No pressure reading was reported before the console would stop the priming process and issue an under-pressure alarm.Inspection of the remainder of the device, apart from the observed damage revealed no other damage or irregularities.

Event Description

Reportable based on the device analysis completed on 16-dec-2022.It was reported that check saline error and pump leak occurred.The target lesion was located in the left lower extremity vein.An angiojet solent omni was used for a thrombectomy procedure with urokinase of 30w units mixed into 100ml normal saline.During the procedure, the power pulse mode was initiated after the standard prime of 15 seconds.After 8 seconds, the catheter alerted check saline error.The device still could not work under power pulse mode even after three attempts.It was then noted that there was liquid coming out of the lower side of the pump.The procedure was completed with another of the same device.No patient complications were reported and patient 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; two scimed place; maple grove MN 55311
• Manufacturer Contact: jay johnson ; 4100 hamline ave n; arden hills, MN 55112 ; 6515810888
• MDR Report Key: 16132948
• MDR Text Key: 308471586
• Report Number: 2124215-2022-56366
• Device Sequence Number: 1
• Product Code: DXE
• Combination Product (y/n): N
• Reporter Country Code: CH
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative,Distributor
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 01/10/2023

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: 04/21/2024
• Device Model Number: 45031
• Device Catalogue Number: 45031
• Device Lot Number: 0029554464
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/05/2022
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 12/16/2022
• Initial Date FDA Received: 01/10/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/23/2022
• 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: 61 YR
• Patient Sex: Male
• Patient Weight: 68 KG