MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION ANGIOJET; CATHETER, CORONARY, ATHERECTOMY

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

Patient Problems Anemia (1706); Hemolysis (1886); Hemorrhage/Bleeding (1888); Renal Failure (2041); Hematuria (2558)

Event Date 07/20/2020

Event Type  Injury  

Manufacturer Narrative

Date of event was approximated from the article received date.Tian, s., et al.(2020).A case report of intravascular hemolysis and heme pigment-induced nephropathy following angiojet thrombectomy for thrombosed dips shunt.Canadian journal of kidney health and disease, 7, pp.1-7.

Event Description

It was reported via journal article that renal issues occurred.The patient was treated with the angiojet system as part of a thrombectomy procedure in a direct intrahepatic portosystemic (dips) shunt.The angiojet activation time was 124 seconds, with 10 mg of tissue plasminogen activator being infused directly into clot.Twenty milliliters of contrast was used intravenously.Before thrombectomy, the patient was given a single dose of naproxen 500 mg.After the procedure, there was significant oozing from the access site (right internal jugular vein) for 48 hours, which required pressure to control.Post-operatively, on day one the patient developed hematuria, followed by dark brown urine, and his creatinine increased to 306 umol/l.The patient developed evidence of worsening anemia, direct antiglobulin test-negative intravascular hemolysis, and severe acute kidney injury.He became progressively oliguric.The patient's hemoglobin dropped acutely following the procedure, requiring one unit of packed red blood cells.The patient was treated with dialysis and was in patient for 18 days after the initial angiojet procedure.Dialysis continued as outpatient and the renal function normalized after 35 days post procedure.

• Brand Name: ANGIOJET
• Type of Device: CATHETER, CORONARY, ATHERECTOMY
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; two scimed place; maple grove MN 55311
• Manufacturer (Section G): BOSTON SCIENTIFIC SCIMED, INC
• Manufacturer Contact: jay johnson ; two scimed place; maple grove, MN 55311 ; 7634942574
• MDR Report Key: 11206846
• MDR Text Key: 227919860
• Report Number: 2134265-2021-00542
• Device Sequence Number: 1
• Product Code: MCX
• Combination Product (y/n): N
• Reporter Country Code: CA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 01/20/2021

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
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 01/14/2021
• Initial Date FDA Received: 01/21/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 45 YR