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

Model Number 45031

Device Problems Display or Visual Feedback Problem (1184); Leak/Splash (1354); Adverse Event Without Identified Device or Use Problem (2993); Pumping Problem (3016)

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

Event Date 12/29/2023

Event Type  malfunction  

Manufacturer Narrative

E1: initial reporter address 1: (b)(6).Device evaluated by mfr.: the product was returned to boston scientific for analysis.Returned product consisted of an angiojet solent omni catheter.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 attempted; however, the device would not prime.During analysis at the severely kinked location at 8 mm from the tip, the hypotube was broken and completely separated.The device could not be functionally tested due to the extreme damage on the device.No pressure reading was reported before the console would stop the priming process and issue an under-pressure alarm.Inspection of the remainder of the device, apart from the observed damage revealed no other damage or irregularities.The complaint was confirmed for under pressure issues related to a hypotube separation.Shaft kinks were also confirmed.

Event Description

Reportable based on device analysis completed on 21-feb-2023.It was reported that error message and leakage occurred.An angiojet solent omni was selected for use in a thrombectomy procedure.A patient with abdominal pain for four days had femoral artery puncture and mesenteric arteriography, which revealed acute thrombosis inside the indicated lesion located in the mesenteric artery.During the procedure, an attempt was made to do thrombus aspiration with a catheter and urokinase injection, however the device indicated an error.All components were then examined again, revealing a substantial amount of liquid in the air sac and a leak in the pump boot.The gadget was reset, but the same issue persisted.The procedure was completed with another of the same device.No patient complications were reported.However, returned device analysis revealed a hypotube break.

• 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: 18897185
• MDR Text Key: 337675237
• Report Number: 2124215-2024-14916
• 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
• Report Date: 03/13/2024

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: 0031491676
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/08/2024
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 02/21/2024
• Initial Date FDA Received: 03/13/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/29/2023
• 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: 70 YR
• Patient Sex: Male
• Patient Weight: 70 KG