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

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

Patient Problems Ecchymosis (1818); Pain (1994); Phlebitis (2004); Ulcer (2274); Numbness (2415)

Event Date 11/17/2020

Event Type  Injury  

Manufacturer Narrative

Title: one-year outcomes of radiofrequency ablation of incompetent perforator veins using the radiofrequency stylet device: cohort study from east asia author: chang-ming wang, shi-lu zhao, qi-chen feng journal: phlebology year: 2020 vol/issue: 0(0) ref: (b)(4), average age, majority gender, date of publication.If information is provided in the future, a supplemental report will be issued.

Event Description

A journal article was submitted detailing a study to assess the outcomes of patient¿s who underwent radiofrequency ablation (rfa) for their incompetent perforator veins (ipvs) with closurefast stylets.117 patients (138 limbs) were included in the study.Medtronic¿s closurefast catheter and rfg generator were used.Immediate technical success was achieved in all cases of ipvs, although repeated access and rfa was performed simultaneously in 6 ipvs in which residual flow was observed after first trial.Complications of ecchymosis and induration, pain (requiring oral medication), paresthesia, and phlebitis phlebitis were reported.1 recurrent ulceration was reported post treatment (2-6 months post procedure).Total of 2.3% of veins were reported to have recanalised at 1 year follow-up.

• 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 ; EI ; 091708734
• MDR Report Key: 11044704
• MDR Text Key: 222625486
• Report Number: 2183870-2020-00445
• Device Sequence Number: 1
• Product Code: GEI
• Combination Product (y/n): N
• Reporter Country Code: CH
• 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: 12/21/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/21/2020
• 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: 12/09/2020
• 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
• Patient Age: 58 YR