MAUDE Adverse Event Report: COVIDIEN LP LLC NORTH HAVEN INSIGSURGI

Model Number VPACK

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

Patient Problems Abscess (1690); Unspecified Infection (1930); Phlebitis (2004); Thrombus (2101); No Code Available (3191)

Event Type  Injury  

Manufacturer Narrative

(b)(4).Title comparison of cyanoacrylate embolization and radiofrequency ablation for the treatment of varicose veins source phlebology, volume 34(4) 278¿283 date of publication: 2018.If information is provided in the future, a supplemental report will be issued.

Event Description

According to literature source of study, a review of clinical outcomes of varicose vein patients treated with radiofrequency ablation (rfa) was performed.The most common complication was superficial phlebitis, which was noted in 16% of rfa patients.Five patients in the rfa group persisted to have some level of paresthesia after the mid-term follow-up, although none of it was debilitating.One case of thrombus extension into the deep system was noted in the rfa treatment group at follow-up ultrasound.One patient in the rfa group had level 3 closure based on the previously proposed classification with thrombus flush with the femoral vein that was treated with three weeks of rivaroxaban.One patient in the rfa group had delayed wound healing at the access site that required outpatient debridement and continued wound care.These wounds eventually healed up at the six weeks follow-up.

• Brand Name: INSIGSURGI
• Type of Device: INSIGSURGI
• Manufacturer (Section D): COVIDIEN LP LLC NORTH HAVEN; 195 mcdermott rd; north haven CT 06473
• Manufacturer (Section G): COVIDIEN LP LLC NORTH HAVEN; 195 mcdermott rd; north haven CT 06473
• Manufacturer Contact: lisa hernandez ; 60 middletown ave.; north haven, CT 06473 ; 2034925563
• MDR Report Key: 8724760
• MDR Text Key: 149145720
• Report Number: 1219930-2019-03653
• Device Sequence Number: 1
• Product Code: GEI
• Combination Product (y/n): N
• Reporter Country Code: CA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,literature
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 06/21/2019

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?: Yes
• Device Operator: No Information
• Device Model Number: VPACK
• Device Catalogue Number: VPACK
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 05/22/2019
• Initial Date FDA Received: 06/21/2019
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Other