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 Consequences Or Impact To Patient (2199)

Event Date 10/06/2020

Event Type  malfunction  

Event Description

It was reported that a loss of aspiration occurred.An angiojet solent omni catheter was selected for treatment.During the procedure, the device was primed and was used on the patient.It was noted that the device began leaking at the bottom of the bulb and would not engage in thrombectomy.The procedure was completed with another of the same device.No patient complications were reported and the patient was fine.

Event Description

It was reported that a loss of aspiration occurred.An angiojet solent omni catheter was selected for treatment.During the procedure, the device was primed and was used on the patient.It was noted that the device began leaking at the bottom of the bulb and would not engage in thrombectomy.The procedure was completed with another of the same device.No patient complications were reported and the patient was fine.It was further reported that the target lesion was located in the superficial femoral artery.It was noted that the catheter would not switch to thrombectomy mode and just stopped.

• 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: 10705571
• MDR Text Key: 212115653
• Report Number: 2134265-2020-14383
• Device Sequence Number: 1
• Product Code: KRA
• UDI-Device Identifier: 08714729889663
• UDI-Public: 08714729889663
• Combination Product (y/n): N
• PMA/PMN Number: K111182
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup
• Report Date: 10/27/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/20/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 04/14/2022
• Device Model Number: 45031
• Device Catalogue Number: 45031
• Device Lot Number: 0025568125
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 10/20/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1