MAUDE Adverse Event Report: COVIDIEN MEDI-TRACE CADENCE; PACEMAKER, CARDIAC, EXTERNAL TRANSCUTANEOUS (NON-INVASIVE)

Model Number 22770PC

Device Problem Gel Leak (1267)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 11/30/2017

Event Type  malfunction  

Manufacturer Narrative

Submit date: 12/22/2017.An investigation is currently under way; upon completion the results will be forwarded.If information is provided in the future, a supplemental report will be issued.

Event Description

The customer reported that the gel from the defib pad is peeling.

Manufacturer Narrative

An investigation of the reported condition was completed.This type of event is commonly referred to gel delamination.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 defect 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 defects will not significantly affect electrode function, but may displease the clinician.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 input document for defibrillation electrodes when the release liner is removed from the electrode, there shall be no more than no more than 45% hydrogel separation from the adult electrode.When the area of separation includes the area of underlying conductive mat, the maximum amount of hydrogel lost is 22% for adult electrodes.With loss of the hydrogel less 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.The device history record (dhr) was reviewed for product 22770pc, lot 605778x, and it passed all acceptance criteria.The production lot number for hydrogel body sub-assembly lot number 603359 did exhibit some minor aesthetic delamination and had no functional delamination.Complaint samples were received in the form of 6 defib electrodes sets from the customer, three (3) of which were in unopened pouches from the customer.The pouches indicated production lot number 605778x.Upon visual inspection of the electrodes in the opened pouches gel delamination from the substrate was observed on two of the electrode sets.The other electrode set in a opened pouch did not exhibit delamination.The degree of delamination on the on the electrode pads was evaluated on the complaint samples (2 sets) in the quality lab as part of the investigation.The degree of gel separation/delamination was determined as follows: three (3) of the six (6) returned samples exhibited delamination.Two (2) of the three (3) had minor delamination no greater than 5.4%.The third electrode set had delamination at 18.6% on one of the pads and 3.7% on the other pad.The delamination did extend into the silver printed area and did include conductive mat area.All of the gel delamination was within 22% maximum hydrogel separation from the adult electrode criteria when the conductive mat area is included.During the evaluation it was also observed that pouches were somewhat in poor condition (i.E.Wrinkled and had marks indicated they may have been stored under a weighted objected- comparison to a production retain in good condition provided in the pictures.Production retains (4 sets) for lot # 605778x were evaluated as well.None of the four (4) retains evaluated exhibited delamination.The results of the testing, pictures of returned sample showing the condition of the electrodes and the delamination observed.Based on the complaint description provided by this complaint is confirmed as gel delamination, however it could not be determined if it was related to manufacturing process.In terms of a potential root causes, either the gel was insufficiently cured (the strength of the bond between the gel and the substrate was too weak) or there was insufficient silicone on the mylar liner (the strength of the bond between the gel and the plastic liner was too strong), however none of the production records or incoming inspection records indicate this occurred.Another potential root cause related to manufacturing is that the silver ink re-mixing was not adequately performed during the sub-assembly printing process.If the silver ink is not adequately it may not properly dry which could result in gel not properly adhering to the silver printed substrate.This may contribute to gel delamination.Silver mixtures can become separated over time because they are suspensions; this is visually detectable prior to use.If re-mixing is required the machine operator documents this process occurred and that the silver mixture met the required acceptance criteria.A review of the production records indicated that silver re-mixing was not required.Additionally, gel delamination may become exacerbated the defib elect rodes are not improper storage.As indicated on the product packaging proper storage and usage of the electrodes is critical to the performance of the gel.The electrodes should be stored in their sealed protective pouch in a cool, dry place and out of direct sunlight.Do not open package until ready for use.Do not bend, fold, or puncture the packaging.Improper storage conditions and/or handling of the product may compromise gel properties prior to the expiration.As previously noted the pouches were in somewhat poor condition.It should be noted that the product was close to the expiration date and that if the was not properly handle/stored the shelf-life (expiration) may be impacted.The environmental and handling condition in which the product was stored was not provided with the complaint.If information is provided in the future, a supplemental report will be issued.

• Brand Name: MEDI-TRACE CADENCE
• Type of Device: PACEMAKER, CARDIAC, EXTERNAL TRANSCUTANEOUS (NON-INVASIVE)
• Manufacturer (Section D): COVIDIEN; 2 ludlow park dr; chicopee MA 01022 1318
• Manufacturer (Section G): COVIDIEN; 2 ludlow park dr; chicopee MA 01022 1318
• Manufacturer Contact: edward almeida ; 15 hampshire street; mansfield, MA 02048 ; 5084524151
• MDR Report Key: 7143531
• MDR Text Key: 95746540
• Report Number: 1219103-2017-05021
• Device Sequence Number: 1
• Product Code: DRO
• UDI-Device Identifier: 10884527022397
• UDI-Public: 10884527022397
• Combination Product (y/n): N
• Reporter Country Code: AS
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 03/14/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/22/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 02/24/2018
• Device Model Number: 22770PC
• Device Catalogue Number: 22770PC
• Device Lot Number: 605778X
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/12/2017
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 11/30/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/25/2016
• Is the Device Single Use?: Yes
• Type of Device Usage: Unknown
• Patient Sequence Number: 1