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

Model Number 45031

Device Problems Leak/Splash (1354); Suction Problem (2170)

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

Event Date 03/01/2024

Event Type  malfunction  

Manufacturer Narrative

E1 - (b)(6).

Event Description

It was reported that loss of aspiration occurred.The patient presented with left lower limb deep vein thrombosis (dvt) due to left iliac vein compression and swollen left lower limb.An angiojet device was selected for use in the thrombectomy procedure.Priming and power pulse mode were normal; however, during the procedure, it was noted that the thrombectomy was weak.The device did not show any error message, and the thrombectomy continued but the malfunction still existed.Upon checking, it was noted that there was a small amount of liquid inside the pump and there was a small amount of blood leaking from the connection between waste bag and the catheter.The device was replaced with another of the same device, and the procedure was completed.There were no complications reported and the patient status was stable.

Event Description

It was reported that loss of aspiration occurred.The patient presented with left lower limb deep vein thrombosis (dvt) due to left iliac vein compression and swollen left lower limb.An angiojet device was selected for use in the thrombectomy procedure.Priming and power pulse mode were normal; however, during the procedure, it was noted that the thrombectomy was weak.The device did not show any error message, and the thrombectomy continued but the malfunction still existed.Upon checking, it was noted that there was a small amount of liquid inside the pump and there was a small amount of blood leaking from the connection between waste bag and the catheter.The device was replaced with another of the same device, and the procedure was completed.There were no complications reported and the patient status was stable.It was further reported that the system stopped all activity; however, the device continued to pump saline when aspiration was lost, and there was liquid noted in the boot.

Manufacturer Narrative

E1 - initial reporter city: (b)(6).

Manufacturer Narrative

E1 - initial reporter city: (b)(6).Device evaluated by mfr.The product was returned to boston scientific for analysis.Returned product consisted of an angiojet solent omni catheter.Inspection of the device revealed multiple bends and shaft kinks; however, the kinks did not disrupt functional testing of the device.The complaint was not confirmed for any pump leaks, set-up issues or alarm messages.

Event Description

It was reported that loss of aspiration occurred.The patient presented with left lower limb deep vein thrombosis (dvt) due to left iliac vein compression and swollen left lower limb.An angiojet device was selected for use in the thrombectomy procedure.Priming and power pulse mode were normal; however, during the procedure, it was noted that the thrombectomy was weak.The device did not show any error message, and the thrombectomy continued but the malfunction still existed.Upon checking, it was noted that there was a small amount of liquid inside the pump and there was a small amount of blood leaking from the connection between waste bag and the catheter.The device was replaced with another of the same device, and the procedure was completed.There were no complications reported and the patient status was stable.It was further reported that the system stopped all activity; however, the device continued to pump saline when aspiration was lost, and there was liquid noted in the boot.

• 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: 18980507
• MDR Text Key: 338623773
• Report Number: 2124215-2024-18124
• 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,Distributor
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 05/07/2024

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: 0031055590
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/21/2024
• Initial Date FDA Received: 03/26/2024
• Supplement Dates Manufacturer Received: 03/29/2024; 04/25/2024
• Supplement Dates FDA Received: 04/16/2024; 05/07/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/26/2023
• 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: Female
• Patient Weight: 56 KG