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

Model Number 22660PC

Device Problem Gel Leak (1267)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 02/09/2017

Event Type  malfunction  

Manufacturer Narrative

Submit date: 3/3/17.An investigation is currently under way; upon completion the results will be forwarded.

Event Description

It was reported to covidien on (b)(6) 2017 that a customer had an issue with a defrib electrode.Communication is not deemed necessary at this time.

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 issue 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 issue 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 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 percentage 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 and it passed all acceptance criteria.No adverse conditions, special circumstances, or events were documented that may have led to the gel delamination.The dhr for the hydrogel body sub-assembly met all acceptance criteria.The raw material records were reviewed as well and all acceptance criteria were met.The uv dosage outputs for curing the hydrogel bodies were within the proper range.The conductive silver/silver chloride ink and gel batch mix sheets were also reviewed.All components and mix time were within tolerance.During the production of hydrogel bodies, four corner peels testing per lab specification, is performed to simulate the removal of the electrode release liner by a clinician prior to delivering therapy (corners of gel body are lifted from the liner to evaluate for release of gel from the substrate).The production lot number for the hydrogel body sub-assembly, did exhibit some minor aesthetic delamination (refer to description previously stated) and had no functional delamination.A complaint sample was received in the form of 1 defib electrodes and one pouch from the customer.The pouch indicated production lot number 616634x.Upon visual inspection of the electrodes gel delamination from the substrate was observed along the edge of one of electrodes in one location for each of the sets.The other electrode pad within each set had no delamination.The degree of delamination was evaluated on the complaint sample (manual single directional peel) in the quality lab as part of the investigation.The degree of gel separation/delamination was determined as follows: one electrode pad had delamination at 7.8% and the other was 0%.The delamination did extend into the silver printed area, however it did not include conductive mat area.All of the gel delamination was within 45% maximum hydrogel separation from the adult electrode criteria.Five (5) production retains were reviewed as well.None of the production retains exhibited delamination.The results of the testing, pictures of returned sample showing the condition of the electrodes and the delamination observed are attached.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 adequate, 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 electrodes 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.The environmental and handling condition in which the product was stored was not provided with the complaint.Based upon the investigative details and the root cause evaluation, no further corrective or preventative actions will be taken at this time in relation to the exhibited delamination.We will continue to trend this issue for future occurrences as part of the complaint review process.If information is provided in the future, a supplemental report will be issued.

Event Description

The silicone layer of the defipad electrode came off while the protection foil was removed.There was no patient involved or harmed.

• Brand Name: MEDI-TRACE CADENCE
• Type of Device: PACEMAKER, CARDIAC, EXTERNAL TRANSCUTANEOUS (NON-INVASIVE)
• Manufacturer (Section D): CHICOPEE MFG DC; 2 ludlow park dr; chicopee MA 01022 1318
• Manufacturer (Section G): CHICOPEE MFG DC; 2 ludlow park dr; chicopee MA 01022 1318
• Manufacturer Contact: edward almeida ; 15 hampshire street; mansfield, MA 02048 ; 5084524151
• MDR Report Key: 6376271
• MDR Text Key: 69018119
• Report Number: 1219103-2017-05001
• Device Sequence Number: 1
• Product Code: DRO
• Combination Product (y/n): N
• Reporter Country Code: NL
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,user facility
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 11/09/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 06/13/2018
• Device Model Number: 22660PC
• Device Catalogue Number: 22660PC
• Device Lot Number: 616634X
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/17/2017
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 02/09/2017
• Initial Date FDA Received: 03/03/2017
• Supplement Dates Manufacturer Received: 08/07/2017
• Supplement Dates FDA Received: 11/09/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/13/2016
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1