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

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

Patient Problems Hemolysis (1886); Pain (1994); Renal Failure (2041)

Event Date 08/23/2019

Event Type  Injury  

Manufacturer Narrative

Date of event estimated using journal article publication date.(b)(6).Journal article citation: esterasm raquel et al.(2019).Podocyte and tubular involvement in angiojet-induced kidney injury.Clinical kidney journal, 14(1), pp.424-428.

Event Description

It was reported via journal article that a patient experienced acute kidney injury following percutaneous mechanical thrombectomy (pmt) with angiojet.The patient was diagnosed with right subclavian vein thrombosis following a trans-atlantic flight.Despite oral anticoagulation, no improvement was observed and 2 weeks later, the patient underwent angiojet pmt.Six hours post-procedure, the patient complained of dark brown urine and bilateral lumbar pain.Serum creatinine (scr) was 2.9 mg/dl (baseline 1.0 mg/dl), platelets 240 000/microliters, haemoglobin (hb) 15 g/dl and lactate dehydrogenase (ldh) 3430 iu/l.The patient had dipstick haematuria +1 and proteinuria 70 mg/dl.Despite intravenous fluid (0.9% sodium chloride and 5% dextrose, 3000-5000 ml/day) and urine alkalinization, 5 days post-procedure the patient's scr was 9.78 mg/dl, hb 11 g/dl, platelets 180 000/microliters, ldh 1030 iu/l, indirect bilirubin 1.3 mg/dl and haptoglobin 5 mg/dl.Direct coombs test was negative and no schistocytes were observed.Dipstick haematuria persisted, urinary protein:creatinine ratio was 731 mg/g and albuminuria was 191 mg/g.Prednisone 40 mg/24 h was started after renal biopsy.The renal biopsy contained 20 glomeruli: these and the vessels in the biopsy appeared normal by light microscopy.Immunofluorescence for immunoglobulin g (igg), iga, igm, c3 and light chains was negative.Severe diffuse acute tubular damage was characterized by tubular necrosis, occasional tubular basement membrane ruptures and adjacent interstitial inflammatory reaction.Tubules were filled with abundant debris encompassing necrotic tubular cells, granular erythrocyte degeneration debris, isolated red blood cells and, in proximal tubules, eosinophilic filiform aggregates that stained for hb.Hb was observed in the cytoplasm of glomerular capillary endothelium, podocytes and tubular cells.Tubular epithelial cells and podocytes stained for ferritin and hemo-oxygenase-1 (ho-1), suggestive of iron overload and an adaptive response to oxidative stress, respectively.The use of transmission electron microscopy showed mild podocyte damage, with foot process widening, large intracellular vacuoles and electron-dense iron deposits.Terminal deoxynucleotidyl transferase dutp nick end labeling (tunel) staining confirmed the presence of dead intratubular cells.Ten days after the procedure, scr peaked at 12 mg/dl while hemolysis was improving (haptoglobin 159 mg/dl, ldh 800 iu/l).Albuminuria was 288 mg/day and proteinuria was 900 mg/day 12 days after thrombectomy.Scr and urinalysis normalized 2 months after the 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 CORPORATION; two scimed place; maple grove MN 55311
• Manufacturer Contact: jay johnson ; two scimed place; maple grove, MN 55311 ; 7634942574
• MDR Report Key: 14646916
• MDR Text Key: 294847729
• Report Number: 2134265-2022-06047
• Device Sequence Number: 1
• Product Code: MCX
• Combination Product (y/n): N
• Reporter Country Code: SP
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Literature,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 06/09/2022

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: 05/19/2022
• Initial Date FDA Received: 06/09/2022
• 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: 28 YR
• Patient Sex: Male