MAUDE Adverse Event Report: BIOSENSE WEBSTER INC STOCKERT 70 SYSTEM; RADIOFREQUENCY GENERATOR AND ACCESSORIES/ACCESSORY CABLE

Catalog Number S7001

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

Patient Problem Partial thickness (Second Degree) Burn (2694)

Event Date 01/24/2018

Event Type  Injury  

Manufacturer Narrative

The hardware investigation has begun but it has not been completed at this time.When the investigational analysis has been completed, a supplemental 3500a report will be submitted.This stockert was manufactured before september 24, 2014, therefore no udi is applicable for this product with serial number (b)(4).Concomitant products: non-biosense webster, inc.- st.Jude medical navx mapping system; non-biosense webster, inc.- 3m indifferent electrode patch (1149c-lp) manufacturer's ref.No: (b)(4).

Event Description

It was reported that a female patient underwent an ablation procedure for typical atrial flutter with a stockert and suffered burns second degree requiring silvadene cream and wound care team consult.During ablation, the patient reported a burning sensation.Patch location was moved.At the end of the procedure, upon checking the grounding pad, burns were noted on the patient¿s back (kidney area) and on the left upper thigh.Patient was reported to be in stable condition.Silvadene cream was applied.Wound care team indicated that the burn was superficial.Patient did not require overnight hospitalization as a result of the event.Patient outcome worsened, as the redness turned into blisters and required wound care follow-up.Physician¿s opinion regarding the cause of the adverse event is that it was procedure-related, specifically a grounding issue.Ablation was performed at 70 watts at 30 seconds.Overall ablation time was 55 minutes using a 8mm catheter.Impedance was approximately 150 ohms.Patient contact area and the indifferent electrode were properly prepared per the indifferent electrode instructions for use.Contact was ideal.Indifferent electrode patches were placed on the mid lower back for first patch and flank for second patch.The first indifferent electrode was positioned at a location on the back as close to the heart as possible.The entire surface area of the grounding pad was in complete contact with the patient¿s back.Upon opening the package for the grounding pad, the conductive gel was present on the indifferent electrode.Upon opening the package for the grounding pad, the indifferent electrode gel was moist.There were no errors reported on any biosense webster, inc.Equipment.Since this adverse event required medical or surgical intervention to preclude permanent impairment of a body function or permanent damage to a body structure, it is to be considered serious and mdr reportable.

Manufacturer Narrative

Investigation summary: it was reported that a female patient underwent an ablation procedure for typical atrial flutter with a stockert and suffered burns second degree requiring silvadene cream and wound care team consult.During ablation, the patient reported a burning sensation.Patch location was moved.At the end of the procedure, upon checking the grounding pad, burns were noted on the patient¿s back (kidney area) and on the left upper thigh.Patient was reported to be in stable condition.Silvadene cream was applied.Wound care team indicated that the burn was superficial.Patient did not require overnight hospitalization as a result of the event.Patient outcome worsened, as the redness turned into blisters and required wound care follow-up.Per business decision, since unit is at end of life (eol), no service will be done.The device history record (dhr) review verifies that the device was manufactured in accordance with documented specification and procedures.Manufacturer's reference number: (b)(4).

• Brand Name: STOCKERT 70 SYSTEM
• Type of Device: RADIOFREQUENCY GENERATOR AND ACCESSORIES/ACCESSORY CABLE
• Manufacturer (Section D): BIOSENSE WEBSTER INC; 33 technology drive; irvine CA 92618
• MDR Report Key: 7284699
• MDR Text Key: 100508978
• Report Number: 2029046-2018-01232
• Device Sequence Number: 1
• Product Code: DRF
• Combination Product (y/n): N
• PMA/PMN Number: P990071
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Type of Report: Initial,Followup
• Report Date: 01/24/2018

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
• Device Operator: No Information
• Device Catalogue Number: S7001
• Initial Date Manufacturer Received: 01/24/2018
• Initial Date FDA Received: 02/20/2018
• Supplement Dates Manufacturer Received: 12/05/2018
• Supplement Dates FDA Received: 12/26/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention