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

Model Number 22550R

Device Problems Gel Leak (1267); Detachment of Device or Device Component (2907)

Patient Problems No Consequences Or Impact To Patient (2199); No Information (3190)

Event Type  malfunction  

Manufacturer Narrative

The incident sample has been requested but to date has not been received for evaluation by the manufacturing plant.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.If information is provided in the future, a supplemental report will be issued.

Event Description

The customer reported the gel on the defibrillator pad was coming off.

Manufacturer Narrative

If information is provided in the future, a supplemental report will be issued.

Manufacturer Narrative

Submission date: (b)(6) 2018.An investigation was performed for the reported customer complaint: ¿the customer reported the gel on the defibrillator pad was coming off.¿ a review of the device history record (dhr) for lot number 616826x, indicates product and specification requirements were met with no non-conforming product identified relating to this customer report.No adverse conditions, special circumstances, or events were documented that may have led to the gel delamination.In addition, dhrs were reviewed for the hydrogel body subassembly utilized in the production of this lot.The production lot number for the hydrogel body sub-assembly did exhibit some minor aesthetic delamination.Aesthetic delamination will not significantly affect electrode function.These lots did not exhibit functional delamination, which is a permanent separation of the hydrogel from the substrate such that the silver/silver chloride ink remains exposed.The dhr¿s for the hydrogel body sub-assemblies met all acceptance criteria.Raw material records were reviewed 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.A lot cannot be released unless it passes all quality and conformance requirements.In-process procedures are also in place to prevent nonconforming product in the manufacturing process.This ensures components and finished products meet all quality inspection standards.These controls include, but are not limited to: material verification/certification processes, dimensional specifications, statistical samplings, periodic audits, process inspections, machine maintenance/operation and personnel training and certification.A complaint sample was received in the form of one (1) defibrillator electrode set.The electrode was received in open, but original packaging.The packaging indicated production lot no.616826x.The electrode was evaluated in the lab.Visual inspection noted the electrodes gel pads had a small portion of the gel missing from along the bottom of one of the electrode pads.It appears that the gel separated from the substrate and may have remained on the carrier liner.The other pad was fully intact.The degree of delamination on the one (1) electrode pad was evaluated in the quality lab as part of the investigation.The degree of gel separation/delamination was determined at 8.3% (91.7% of gel remained intact).The delamination did extend slightly into the silver printed area, and it did not include conductive mat area.The gel delamination was within an acceptable range for hydrogel separation for adult electrode criteria.Five (5) production retained sets for lot no.616826x were also evaluated.One (1) of the five (5) retains evaluated exhibited delam ination.The delamination did extend slightly into the silver printed area, and it did not include conductive mat area.The gel delamination was within an acceptable range for hydrogel separation for adult electrode criteria.The customer supplied a picture of an electrode exhibiting delamination and the pouch.This electrode and pouch was not returned for evaluation.The condition of the pouch in the picture could not be determined.The reported event is commonly referred to as 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.During the production of hydrogel bodies, four-corner peel testing 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).Potential root causes may include: 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).The silver ink re-mixing was not adequately performed during the sub-assembly printing process.If not adequately re-mixed 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.Gel delamination may become exacerbated if the defibrillator electrodes are improperly stored.Improper storage conditions and/or handling of the product may also compromise gel properties prior to the expiration.The environmental and handling condition in which the product was stored was not provided with the complaint.Product packaging, proper storage and usage of the electrodes are critical to the performance of the gel.None of the production records or incoming inspection records indicated any of these scenarios occurred.Based on the customer complaint description provided, gel delamination most likely occurred.The reported customer complaint is confirmed.A root cause could not be determined.No corrective or preventive action is planned at this time.This complaint will be used for trending purposes.

• Brand Name: MEDI-TRACE CADENCE
• Type of Device: PACEMAKER, CARDIAC, EXTERNAL TRANSCUTANEOUS (NON-INVASIVE)
• Manufacturer (Section D): COVIDIEN CHICOPEE MFG DC; 2 ludlow park dr; chicopee MA 01022 1318
• MDR Report Key: 7715604
• MDR Text Key: 114956032
• Report Number: 1219103-2018-00013
• Device Sequence Number: 1
• Product Code: DRO
• UDI-Device Identifier: 20884527022332
• UDI-Public: 20884527022332
• 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: 10/04/2018
• 2 Devices were Involved in the Event: 1 2

1 Patient was Involved in the Event

• Date FDA Received: 07/24/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 06/15/2018
• Device Model Number: 22550R
• Device Catalogue Number: 22550R
• Device Lot Number: 616826X
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 08/08/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1