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 02/20/2023

Event Type  malfunction  

Manufacturer Narrative

Initial reporter address 1: (b)(6).

Event Description

It was reported that loss of aspiration occurred.The target lesion was located in the left lower extremity veins.An angiojet solent omni catheter was selected for treatment.However, during the procedure under thrombectomy mode, a large amount of blood found flowing out under the catheter interface that causes insufficient suction.The procedure was completed with another of same device.There were no patient complications reported and the patient's status was stable.

Event Description

It was reported that loss of aspiration occurred.The target lesion was located in the left lower extremity veins.An angiojet solent omni catheter was selected for treatment.However, during the procedure under thrombectomy mode, a large amount of blood found flowing out under the catheter interface that causes insufficient suction.The procedure was completed with another of same device.There were no patient complications reported and the patient's status was stable.

Manufacturer Narrative

E1 - initial reporter address 1: (b)(6).Device evaluated by mfr.: returned product consisted of an angiojet omni catheter.Media was returned in the form of a photo/diagram.The photo/diagram was reviewed which showed where the alleged leak was observed at the customer site and was not confirmed during analysis.The effluent line and catheter were cut off the device from the customer site with 15 cm remaining of the pump component.The pump and effluent line, waste line, hub and catheter shaft were returned severed and completely separated from the pump.The catheter shaft showed no damage.Functional testing could not be completed per device preparation due to the extreme damage.Inspection of the remainder of the device, apart from the observed damage revealed no damage or irregularities.

• 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: 16565398
• MDR Text Key: 311506896
• Report Number: 2124215-2023-11095
• 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,Followup
• Report Date: 04/20/2023

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 Model Number: 45031
• Device Catalogue Number: 45031
• Device Lot Number: 0029944103
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 02/27/2023
• Initial Date FDA Received: 03/17/2023
• Supplement Dates Manufacturer Received: 04/11/2023
• Supplement Dates FDA Received: 04/20/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/28/2022
• 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: 70 YR
• Patient Sex: Male
• Patient Weight: 73 KG