MAUDE Adverse Event Report: COVIDIEN 3010188-020 QC RTS 1/P 10/B 50; PACEMAKER, CARDIAC, EXTERNAL TRANSCUTANEOUS (NON-INVASIVE)

Model Number PM20003

Device Problem Peeled/Delaminated (1454)

Patient Problems No Consequences Or Impact To Patient (2199); No Patient Involvement (2645)

Event Type  malfunction  

Manufacturer Narrative

The incident sample has been requested but to date has not been received for evaluation.If the sample is received, or if additional information pertinent to the incident is obtained a follow-up report will be submitted. as part of our manufacturing process, all device history records are reviewed and approved by quality, prior to release of product.

Event Description

The customer reported that the gel is delaminating from the electrode.

Manufacturer Narrative

A review of the device history record (dhr) and no abnormal process conditions were present during the manufacturing of the product that could have led to the reported condition as described by the customer.The dhr review show that all acceptance criteria inspections were within acceptable limits during the production process, this testing includes peel testing to inspect for delamination.The sample was not provided for evaluation therefore the reported condition could not be confirmed.From a root cause analysis perspective, the review of the dhr shows the expiration date of the product was in december of 2019.The product holds a 30-month shelf life and was produced in june of 2017.The complaint aware date is june of 2020, this indicates most likely the product was used after it had expired.Possible causes of gel delamination within the expiration period is in relation to the uv curing process, which can affect the gel body more so as the finished product ages and gets closer to the expiration date.Gel delamination occurs when the gel-to-release liner bond strength is greater than the cohesive strength of the gel or greater than the gel-to-substrate bond strength.Such an inequity in bond strength can cause the gel to peel from the substrate and/or tear.Delamination is categorized as follows: an aesthetic delamination is characterized by a permanent separation of the hydrogel from the substrate, exposing the underlying carbon vinyl with little (i.E.Area less than 1/8 inch x 1/8 inch) or no hydrogel remains on the release liner.Also, no silver/silver chloride ink is exposed.Aesthetic delamination will not significantly affect electrode function but may displease the clinician.This is the condition as described: functional delamination is a permanent separation of the hydrogel from the substrate such that the silver/silver chloride ink remains exposed.Additionally, per the defibrillation electrodes design specification for defibrillation electrodes there shall be no less than 55% hydrogel remaining on the adult electrode when the release liner is removed from the electrode.There shall be no less than 78% hydrogel remaining on the adult electrode, when the area of separation includes the area of underlying conductive mat.With loss of the hydrogel no more than the percentages as defined above the electrodes retain functionally essential performance; however the reduction in the hydrogel area with the silver/silver chloride ink being exposed may cause an increase in current density across the remaining gel area.This increases the potential for skin irritation and burns.Proper storage and usage of the electrodes is critical to the performance of the gel.The electrodes should be stored in their sealed, foil lined pouches away from extreme heat and humidity.Failure to ensure product is stored correctly can affect the product and result in issues with the gel.The results of the manufacturing facility investigation, based on the age of the product lot number, were unable to confirm any potential root causes associated with the manufacture of product which would have contributed to the reported condition.No corrective or preventative actions are necessary.It should be noted that since the production of the reported lot, an improved uv curing system has been approved and implemented.The variable power output allows more flexibility to dial in the uv intensity while mitigating excess heat generation in the oven and improving single directional peel (delamination) performance throughout the life of the product.We will continue to trend this issue for future occurrences as part of the complaint review process.

Event Description

The customer reported that the gel was delaminating from the electrode.When the liner was peeled off the gel was removed off with the liner.There was no patient involvement.

Manufacturer Narrative

Sections b5 and e6 (patient code) have been updated to reflect additional information provided by the customer on july 29, 2020.

• Brand Name: 3010188-020 QC RTS 1/P 10/B 50
• Type of Device: PACEMAKER, CARDIAC, EXTERNAL TRANSCUTANEOUS (NON-INVASIVE)
• Manufacturer (Section D): COVIDIEN; 2 ludlow parkway; chicopee MA 01022
• MDR Report Key: 10272639
• MDR Text Key: 198771927
• Report Number: 1219103-2020-00298
• Device Sequence Number: 1
• Product Code: DRO
• UDI-Device Identifier: 00721902195037
• UDI-Public: 00721902195037
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,user f
• Type of Report: Initial,Followup,Followup
• Report Date: 09/11/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/14/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: PM20003
• Device Catalogue Number: PM20003
• Device Lot Number: 717030
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 06/23/2020
• Patient Sequence Number: 1