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

Model Number 45031

Device Problems Break (1069); Display or Visual Feedback Problem (1184)

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

Event Date 03/11/2024

Event Type  malfunction  

Event Description

It was reported that a fracture on the catheter occurred.The patient underwent a thrombectomy on the femoral vein.An angiojet solent omni catheter was selected for the procedure.During insertion, it was found that the metal material of the device was twisted and fractured mid-shaft about 50 cm away from the hub.The damage occurred on a portion of the device that was outside the patient.This populated an error that displayed continuously when the catheter was flushed.It was noted that the device was not carefully checked before use.The procedure could not be performed without flushing the device, so it was replaced for another of the same model to complete it.No complications reported, and patient status was stable.

Manufacturer Narrative

Device evaluated by mfr.: device was returned for analysis and went through inspection.The device revealed a broken/loose connector, and supply line separation.Functional testing failed due to an under-pressure alarm message.The complaint was confirmed for under-pressure issues related to a supply line separation along with a damaged/loose connector.

Event Description

It was reported that a fracture on the catheter occurred.The patient underwent a thrombectomy on the femoral vein.An angiojet solent omni catheter was selected for the procedure.During insertion, it was found that the metal material of the device was twisted and fractured mid-shaft about 50 cm away from the hub.The damage occurred on a portion of the device that was outside the patient.This populated an error that displayed continuously when the catheter was flushed.It was noted that the device was not carefully checked before use.The procedure could not be performed without flushing the device, so it was replaced for another of the same model to complete it.No complications reported, and patient status was stable.

• 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: rachel shields ; 4100 hamline ave n; arden hills, MN 55112 ; 6512422111
• MDR Report Key: 19034355
• MDR Text Key: 339269622
• Report Number: 2124215-2024-19875
• 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: Other,Foreign,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 04/03/2024

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 Model Number: 45031
• Device Catalogue Number: 45031
• Device Lot Number: 0031493580
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/12/2024
• Initial Date FDA Received: 04/03/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/05/2023
• 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: 67 YR
• Patient Sex: Male
• Patient Weight: 64 KG