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

Model Number 45031

Device Problem Mechanical Problem (1384)

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

Event Date 01/29/2021

Event Type  malfunction  

Event Description

It was reported that air in the catheter shaft occurred.The target lesion was located in the left lower limb.After an unknown 6f sheath and 0.035 guidewire were inserted, an angiojet solent omni catheter was advanced for treatment.The patient was placed in prone position.During the procedure after 15 seconds in thrombectomy mode, it was noted that there were large amount of bubbles inside the catheter shaft.There was air flowed inside the catheter.The device was aspirating and functioning normally.The procedure was completed with another of the same device.No patient complications were reported and patient's status was stable.

Manufacturer Narrative

Device evaluated by mfr.: 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 a kink located 108cm from the tip.Functional testing was completed per device preparation.The pump was inserted into the ultra drive unit console.The pump and device primed, and the device was run for a period of 120 seconds in the thrombectomy mode.The devices pressure was within the normal range.Inspection of the remainder of the device, apart from the observed damage revealed no other damage or irregularities.

Event Description

It was reported that air in the catheter shaft occurred.The target lesion was located in the left lower limb.After an unknown 6f sheath and 0.035 guidewire were inserted, an angiojet solent omni catheter was advanced for treatment.The patient was placed in prone position.During the procedure after 15 seconds in thrombectomy mode, it was noted that there were large amount of bubbles inside the catheter shaft.There was air flowed inside the catheter.The device was aspirating and functioning normally.The procedure was completed with another of the same device.No patient complications were reported and 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
• MDR Report Key: 11561575
• MDR Text Key: 242008908
• Report Number: 2134265-2021-03198
• Device Sequence Number: 1
• Product Code: DXE
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,distri
• Type of Report: Initial,Followup
• Report Date: 04/16/2021

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: 02/11/2022
• Device Model Number: 45031
• Device Catalogue Number: 45031
• Device Lot Number: 0025476425
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/18/2021
• Initial Date Manufacturer Received: 02/24/2021
• Initial Date FDA Received: 03/24/2021
• Supplement Dates Manufacturer Received: 03/31/2021
• Supplement Dates FDA Received: 04/16/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 58 YR
• Patient Weight: 58