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

Catalog Number	CF7-7-100
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Inflammation (1932); Pain (1994); Reaction (2414)
Date of Event	10/13/2017
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4) image analysis: four photographic images received from customer revealed patient suffered severe swelling, blistering, bruise , redness and infections to both legs.If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
Physician used a closurefast catheter to perform radiofrequency ablation treatment of the great saphenous vein (gsv) and short saphenous vein (ssv).4 segments were treated (both gsv's and both ssv's) and the vein did close.These procedures were carried out over 2 days - right gsv and right ssv treated with rf ablation on the first procedure day.Left gsv and left ssv treated with rf ablation on the second procedure day.Ifu was followed and the procedure was carried out as normal.During follow-up (approximately 2-3 weeks later), it was observed that skin irritation, blistering and ulcerations had developed and progressively worsened, and patient experienced pain, swelling, and redness.The patient¿s family reported that a cream was applied to the skin irritation sites and that the patient is allergic to a component in the cream - it was unknown what cream or component in the cream the patient was allergic to.Additional treatment required included wound therapy and compression.Patient was referred to another clinic for possible ven a seal procedure; referral physician did not see any need to treat with vena seal, since all superficial veins previously treated were closed.A small amount of minimal ultrasound-guided foam sclerotherapy was injected into a small tributary near the skin irritation and ulcers.It has been reported that the patient had no symptoms of leg ulcers prior to the radiofrequency ablation treatments.

• Brand Name: CLOSUREFAST CATHETER
• Common Device Name: ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES
• Manufacturer (Section D): MEDTRONIC; 4600 nathan lane north; plymouth,mn
• MDR Report Key: 7023176
• Report Number: 2183870-2017-00500
• Device Sequence Number: 19170820
• Product Code: GEI
• UDI-Device Identifier: 10884521058057
• UDI-Public: 10884521058057
• Combination Product (Y/N): N
• Initial Reporter State: AZ
• Initial Reporter Country: US
• PMA/510(K) Number: K111887
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 11/10/2017

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
• Operator of Device: Health Professional
• Device Expiration Date: 03/31/2016
• Device Catalogue Number: CF7-7-100
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/13/2017
• Initial Report FDA Received Date: 11/10/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 80 YR
• Patient Weight: 82