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

Model Number 45031

Device Problems Display or Visual Feedback Problem (1184); Adverse Event Without Identified Device or Use Problem (2993)

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

Event Date 09/15/2022

Event Type  malfunction  

Manufacturer Narrative

Device evaluated by mfr: returned product consisted of the solent omni thrombectomy.The pump, effluent/supply line, shaft, tip, piston, and spike line were visually inspected.Visual examination revealed multiple kinks along the distal shaft.Microscopic examination revealed no additional damages.Functional testing was performed, and the device kept reading low pressure then stop priming.The shaft was cut open and the hypotube is separated 19.5cm from the strain relief.Inspection of the device presented no other damage or irregularities.Product analysis confirmed damage to the hypotube which would have contributed to the reported error message.

Event Description

Reportable based on the device analysis completed on 08dec2022.It was reported that device alerted an error message.The target lesion was located in the deep vein left lower extremity.An angiojet solent omni was used for the thrombectomy procedure.During procedure, power pulse was used to spray 96 cc of urokinase.The catheter was removed from the body for 20 minutes before being reinserted and began in thrombectomy mode.Three consecutive operations failed, and the angiojet displayed perseverative error, preventing the catheter from being utilized.The procedure was completed with another of the same device.There were no patient complications reported and the patient was stable.However, returned device analysis revealed a separated hypotube.

• 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: 16023429
• MDR Text Key: 306344490
• Report Number: 2124215-2022-54104
• 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: 12/21/2022

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: 03/07/2024
• Device Model Number: 45031
• Device Catalogue Number: 45031
• Device Lot Number: 0029282253
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/17/2022
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 12/08/2022
• Initial Date FDA Received: 12/21/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/08/2022
• 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: 58 YR
• Patient Sex: Female
• Patient Weight: 58 KG