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

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

Patient Problems Bradycardia (1751); Hematoma (1884); Hemorrhage/Bleeding (1888); Hypersensitivity/Allergic reaction (1907); Renal Failure (2041); Injury (2348); Hematuria (2558)

Event Date 05/05/2020

Event Type  Injury  

Manufacturer Narrative

Pouncey al et al., angiojet pharmacomechanical thrombectomy and catheter directed thrombolysis vs.Catheter directed thrombolysis alone for the treatment of iliofemoral deep vein thrombosis: a single centre retrospective cohort study, european journal of vascular and endovascular surgery, https://doi.Org/10.1016/j.Ejvs.2020.05.006, pp.1-8.Date of event was approximated using date of article acceptance.

Event Description

It was reported via journal article that patient complications occurred.Data was reviewed to examine the outcomes of patients treated with additional angiojet zelantedvt pharmacomechanical thrombectomy (pcdt) vs.Catheter directed lysis (cdt) alone.Vascular access was obtained via the popliteal vein, which was performed under direct ultrasound guided puncture.Access guidewires were placed into the inferior vena cava using standard techniques.Angiojet was either performed with initial powerpulse followed by aspiration mode, if performed during the primary procedure, or in aspiration mode if following on from a previous period of cdt.If a clear obstructive lesion or obvious residual chronic disease was identified, this was treated by balloon venoplasty and stent placement.The technique of balloon venoplasty and stent placement followed standard methodology.Anticoagulation was monitored during the index procedure with measures of intraprocedural activated clotting time (act) following cessation of lytic therapy and appropriate dosing with intravenous heparin to maintain an act of >250 s.Intermittent pneumatic compression (ipc) was applied from the start of lysis and maintained post procedure until discharge.Following completion of lysis, all access catheters were removed in the treatment room and compression stockings were applied in addition to ipc.Therapeutic low molecular weight heparin (lmwh) was commenced within one hour of procedure completion.Patients received two weeks of therapeutic lmwh with transition to oral anticoagulation therapy following a surveillance duplex at two weeks.Complications of post-thrombotic syndrome, hemoglobinuria, acute kidney injury, epistaxis, hematoma, transient bradycardia and minor allergic reaction (classified as the presence of a rash) occurred.

• 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; 500 commander shea boulevard; quincy MA 02171
• Manufacturer Contact: jay johnson ; two scimed place; maple grove, MN 55311 ; 7634942574
• MDR Report Key: 10547776
• MDR Text Key: 207358152
• Report Number: 2134265-2020-12844
• Device Sequence Number: 1
• Product Code: MCX
• Combination Product (y/n): N
• Reporter Country Code: UK
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 09/17/2020

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
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 09/02/2020
• Initial Date FDA Received: 09/17/2020
• 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): Other