MAUDE Adverse Event Report: COVIDIEN CLOSUREFAST CATHETER; ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES

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

Patient Problems Burn(s) (1757); Ecchymosis (1818); Edema (1820); Hematoma (1884); Pain (1994); Phlebitis (2004); Increased Sensitivity (2065); Burning Sensation (2146); Tingling (2171); Numbness (2415); Patient Problem/Medical Problem (2688)

Event Date 01/14/2019

Event Type  Injury  

Manufacturer Narrative

Available online journal article title: twelve-month efficacy and complications of cyanoacrylate embolization compared with radiofrequency ablation for incompetent great saphenous veins copyright 2018 by the society for vascular surgery.Published by elsevier inc.Https://doi.Org/10.1016/j.Jvsv.2018.10.019.If information is provided in the future, a supplemental report will be issued.

Event Description

Introduction: in this study, the clinical results of radiofrequency ablation (rfa) and n-butyl-cyanoacrylate embolization (cae) methods were compared in the treatment of incompetent great saphenous veins (gsvs).The latter method employed the new ca embolization system, venablock (invamed, ankara, turkey).Methods: this independent retrospective study included 244 patients (128 patients rfa, 116 patients cae) with incompetent great saphenous veins (gsvs) who applied to eskisehir osmangazi university hospital of faculty of medicine, cardiovascular surgery clinic, between june 2013 and june 2016 and were treated with rfa or cae.No additional procedures, such as miniphlebectomy or sclerotherapy, were performed.All patients treated with rfa underwent spinal or general anesthesia in the coronary surgery operating room.Puncture was performed with seldinger technique on the vsm from an appropriate area at kneelevel under ultrasound guidance, and a 7f sheath was placed.The rfa applicator was passed through the sheath under ultrasound guidance.The extreme end of the catheter was carried forward about 2 cm distal of the sfj.An average of 320 ml ta was applied to all patients.Covidien closurerfg radiofrequency generator and covidien closure fast endovenous rfa catheter were used.The procedure was completed by ablating 15 seconds at 120c on each 7-cm segment at knee level.Results: a total of 244 patients with lower extremity venous insufficiency were enrolled in the study.The average age was 46.30 years in the rfa group and 49.21 years in the cae group.No other characteristics were noted except rheumatoid arthritis (n=1), psoriatic arthritis (n=3), psoriasis (n 5), malignancy (n=1), hypertension (n=19), and diabetes (n=13) in the patients¿ history.Skin burn, which we consider a major complication, occurred only in one patient.No other major complications were seen in either group.Severe pain, ecchymosis, and sensitivity were the most common of the side effects, and these side effects were significantly higher in rfa group than in cae group.Paresthesia was seen in three patients, hematoma in one patient, and anesthesia-related urinary retention in three patients was seen in the rfa group, but none occurred in the cae group.Major complications, such as dvt, were not observed in either group in our study.Pain, ecchymosis, and sensitivity were the most common side effects and these side effects were significantly higher in the rfa than in the cae group.There was only one slight hematoma that developed in one patient in our study.Skin burn on a small area occurred in one patient owing to a superficial gsv, and slight paresthesia developed in three patients because of rfa¿s high thermal effect.These complications quickly improved with simple medical interventions.A pigmentation increase was observed in four patients in rfa group and two patients in cae group at superficial small parts close to the entry point.Conclusions: based on the present data, our findings suggest that cae is as effective as rfa ablation with similar rates of successful occlusion.Cae may be associated with less pain and fewer complications than rfa and might provide better patient comfort.The current results should be verified with further randomized, controlled trials with longer term follow-up and larger patient groups.

• Brand Name: CLOSUREFAST CATHETER
• Type of Device: ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES
• Manufacturer (Section D): COVIDIEN; 4600 nathan lane north; plymouth MN 55442
• Manufacturer (Section G): COVIDIEN; 4600 nathan lane north; plymouth MN 55442
• Manufacturer Contact: toni o'doherty ; parkmore business park west; galway ; 091708734
• MDR Report Key: 8439180
• MDR Text Key: 139596883
• Report Number: 2183870-2019-00140
• Device Sequence Number: 1
• Product Code: GEI
• Combination Product (y/n): N
• Reporter Country Code: TU
• PMA/PMN Number: K111887
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 03/21/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/21/2019
• 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
• Date Manufacturer Received: 02/25/2019
• 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): Required Intervention
• Patient Age: 46 YR