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

Model Number 45031

Device Problem Pumping Problem (3016)

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

Event Date 02/16/2023

Event Type  malfunction  

Manufacturer Narrative

E1: initial reporter facility name: (b)(6) hospital.Device evaluated by mfr: returned product consisted of an solent omni thrombectomy.The pump, effluent/supply line, shaft, tip, piston, and spike line were visually inspected.Visual examination revealed that multiple kinks along the shaft.Microscopic examination revealed that the hypotube is separated 25.5cm from the tip.Functional testing was performed by placing the device in the angiojet ultra console.The device did not prime and there was a check saline supply error.Inspection of the device presented no other damage or irregularities.Product analysis confirmed the hypotube is separated which would cause the device to have and error and leak.

Event Description

Reportable based on device analysis completed on (b)(6) 2023.It was reported that pump seal fault occurred.The target location was located in the deep vein thrombosis of the left lower extremity.An angiojet solent omni was used for a thrombectomy procedure.During the procedure while in thrombectomy mode for 30 seconds, it was found that there was liquid in the air sac of the pump resulting to insufficient suction and affecting the procedure.The procedure was completed with another of the same device.No patient complications were reported, and the patient 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; 300 boston scientific way; marlborough MA 01752
• Manufacturer (Section G): BOSTON SCIENTIFIC CORPORATION; two scimed place; maple grove MN 55311
• Manufacturer Contact: jeff wallner ; 4100 hamline ave n; arden hills, MN 55112 ; 6515811560
• MDR Report Key: 16919186
• MDR Text Key: 315089814
• Report Number: 2124215-2023-21458
• 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: 05/12/2023

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: 07/04/2024
• Device Model Number: 45031
• Device Catalogue Number: 45031
• Device Lot Number: 0030015494
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/06/2023
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 04/19/2023
• Initial Date FDA Received: 05/12/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/05/2022
• 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: 63 YR
• Patient Sex: Female
• Patient Weight: 52 KG