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 02/20/2024

Event Type  malfunction  

Event Description

It was reported that loss of aspiration occurred.The 90% stenosed target lesion was located in the severely tortuous iliac vein.An angiojet solent omni catheter was selected for treatment.However, after 60 seconds of thrombectomy mode with this catheter, the catheter leak was serious and there was no suction effect noted.There was no visible damage to the catheter, but there was liquid in the pump.The procedure was completed with another of the same catheter.There were no patient complications reported and the patient's status was stable.

Manufacturer Narrative

Device evaluated by mfr: the complaint device was received for product analysis.Inspection of the device revealed multiple bends and shaft kinks; however, the kinks did not disrupt functional testing of the device.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.The complaint was not confirmed for any pump leaks, set-up issues or alarm messages.No other issues were identified during the product analysis.

Event Description

It was reported that loss of aspiration occurred.The 90% stenosed target lesion was located in the severely tortuous iliac vein.An angiojet solent omni catheter was selected for treatment.However, after 60 seconds of thrombectomy mode with this catheter, the catheter leak was serious and there was no suction effect noted.There was no visible damage to the catheter, but there was liquid in the pump.The procedure was completed with another of the same catheter.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; 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: 18876984
• MDR Text Key: 337348834
• Report Number: 2124215-2024-11583
• 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
• Report Date: 04/19/2024

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: 0031374886
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 02/23/2024
• Initial Date FDA Received: 03/11/2024
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 04/19/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/17/2023
• 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: 28 YR
• Patient Sex: Male