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

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

Patient Problems Pain (1994); Reaction (2414)

Event Date 09/28/2017

Event Type  Injury  

Manufacturer Narrative

If information is provided in the future, a supplemental report will be issued.

Event Description

Physician used a closurefast catheter with an rfg3 for a radiofrequency ablation(rfa) treatment of the left greater saphenous vein.The rfa procedure went as planned, however the physician did experience difficulty during access.General anesthesia was not used.A 700ml of tumescent was used.A 53cm of vessel was treated in 22 cycles.Total treatment time 7mins 20 seconds.No error codes/messages were displayed on the generator.Patient began experiencing pain after procedure.Pain/swelling in lower extremity/calf.After 1 week post-procedure, a rash was present on the upper thigh and a ¿dimple¿ was noticed on the thigh.Follow-up ultrasound report: moderate compressibility, without evidence of definite recanalization of flow.Physician believes possible nerve injury is the cause of pain and that residual le swelling may be due to reflux in the deep system as well.Patient was referred to vascular surgery which confirmed successful gsv ablation and that possible nerve injury would resolve.Reflux in the deep system may require long term stockings.Repeat ultrasounds showed successful vein ablation without evidence of dvt.Large varicosities noted on physical exam have resolved and pain better last time seen.

• 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: 7122766
• MDR Text Key: 95013275
• Report Number: 2183870-2017-00580
• Device Sequence Number: 1
• Product Code: GEI
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K111887
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 12/15/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/15/2017
• 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: 11/20/2017
• 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: 36 YR
• Patient Weight: 96