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

Model Number 45031

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Abdominal Pain (1685); Renal Failure (2041); Pancreatitis (4481)

Event Date 09/23/2023

Event Type  Injury  

Event Description

It was reported that the patient suffered from epigastric pain, renal failure, and pancreatitis as a result of the angiojet procedure, and required additional intervention.An angiojet solent omni was selected for use in the thrombectomy procedure to treat in-stent occlusion of the right leg.Thrombolysis was started on (b)(6) 2023.On september 23, the patient suffered severe ischemia.An angiojet thrombectomy was performed for a maximum of 400sec in total.Glomerular filtration rate (gfr) was 53/ml/min.The occlusion was completely cleared and intervention with the angiojet was successful.On the evening of september 23, the patient suffered epigastric pain.On (b)(6) lipase was at 2027 units/liter and gfr was at 18ml/min.The patient was suffering from renal failure and pancreatitis and had to go to dialysis.The patient was initially admitted into intensive care, and after some time, was transferred to mid-care.Between (b)(6) and (b)(6), the patient went on dialysis three times per week.The patient remained in the hospital until (b)(6), when he was discharged.The patient was reported to have recovered fully.

• 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: 18219904
• MDR Text Key: 329153323
• Report Number: 2124215-2023-64405
• Device Sequence Number: 1
• Product Code: DXE
• Combination Product (y/n): N
• Reporter Country Code: BE
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 11/28/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 45031
• Device Catalogue Number: 45031
• Device Lot Number: 0032050242
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 10/30/2023
• Initial Date FDA Received: 11/28/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/07/2023
• 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 Outcome(s): Hospitalization; Required Intervention