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

Model Number 45031

Device Problems Suction Problem (2170); Material Integrity Problem (2978); Air/Gas in Device (4062)

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

Event Date 11/11/2022

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

It was reported that loss of aspiration occurred.The target lesion was located in the lower extremity veins.An angiojet solent omni catheter was selected for treatment.However, during the procedure, the distal end of the catheter had no suction and could not perform thrombectomy normally due to large amount of air being accumulated in the pump and reflux of waste fluid ceased.The issue was not resolved after many times of attempt and decided to replace another of same device to complete the procedure.There were no patient complications reported and the patient's status was stable.

Manufacturer Narrative

E1: (b)(6).Device evaluated by mfr.: returned product consisted of the solent omni catheter.The pump number for the device is (b)(6).The pump number was reviewed and confirmed to be from finished goods batches: 29000878, or 29000877 and not the reported batch number 0028588226.The pump assembly, effluent/supply line, shaft, tip, and spike line were visually examined for damage or any irregularities.The catheter shaft showed multiple bends and kinks.Functional testing was completed by inserting the pump into the ultra drive unit console.The catheter primed, and the device functioned for a period of 90 seconds in the thrombectomy mode.The devices pressure was within the normal range.The catheter tip was placed into a 100 ml beaker and ran for approximately 30 seconds at which point it was verified the device was aspirating normally.During functional testing no errors or priming issues were observed, the device ran as designed.Inspection of the remainder of the device, apart from the observed damage revealed no other damage or irregularities.

Event Description

It was reported that loss of aspiration occurred.The target lesion was located in the lower extremity veins.An angiojet solent omni catheter was selected for treatment.However, during the procedure, the distal end of the catheter had no suction and could not perform thrombectomy normally due to large amount of air being accumulated in the pump and reflux of waste fluid ceased.The issue was not resolved after many times of attempt and decided to replace another of same device to complete the procedure.There were no patient complications reported and the patient's status was stable.

• 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: 15881412
• MDR Text Key: 307670468
• Report Number: 2124215-2022-48744
• 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: 01/18/2023

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: 01/17/2024
• Device Model Number: 45031
• Device Catalogue Number: 45031
• Device Lot Number: 0029000877
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 11/15/2022
• Initial Date FDA Received: 11/29/2022
• Supplement Dates Manufacturer Received: 12/27/2022
• Supplement Dates FDA Received: 01/18/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/17/2022
• 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: 55 YR
• Patient Sex: Male
• Patient Weight: 68 KG