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

Model Number	PM20003
Medical Device Problem Code	Peeled/Delaminated (1454)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	05/26/2021
Type of Reportable Event	Malfunction
Additional 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 or Problem Description
Customer reports that one of their customers reported that an electrode was found to be experiencing adhesive/gel damage when the pad was peeled.
Additional Manufacturer Narrative
The device history records (dhr) were reviewed for both the finished good and the sub-assemblies manufactured at the plant, 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 customer provided a picture of the issue where a small portion of the gel delaminated from the silver area of the gel body.An additional picture of the lot number label on the pouch indicated that the gel body used would have come from lot 934354.Samples were received from the customer in the form of 9 unopened/sealed pouches.A visual inspection of the pouches did not show any damage to the pouch or the seal.Additionally, a visual inspection of the product prior to testing did not show any signs of damage or anything that may have indicated an issue with the product.A traceability number on the back of the pouches indicated that the returned samples would have been made from gel bodies from lot 934354.Physical testing was performed on the samples using the single direction peel test.This is a test that uses an instron to peel the gel body from the liner and to inspect for gel delamination.This test resulted in delamination on the samples returned, with over 50 percent of the gel delaminating from the silver portion of the gel body.The test results from the nine returned samples showed delamination where the gel had a tighter bond to the liner than the silver and carbon vinyl that it is designed to be tightly bonded to.It is important to note that gel delamination is addressed in all risk documentation associated with defibrillation electrodes.The results of the manufacturing facility investigation were unable to confirm any potential root causes associated with the manufacture of product which would have contributed to the reported condition.Indications from the returned samples indicate a localized problem during the gel body manufacturing process.However, because it was in the returned samples but not in the retains from the same lot it was not possible to verify with certainty.No corrective or preventative actions will be taken at this time.We will continue to trend this issue for future occurrences as part of the complaint review process.

• Brand Name: 3010188-020 QC RTS 1/P 10/B 50
• Common Device Name: PACEMAKER, CARDIAC, EXTERNAL TRANSCUTANEOUS (NON-INVASIVE)
• Manufacturer (Section D): COVIDIEN; 2 ludlow parkway; chicopee MA 01022
• Manufacturer (Section G): COVIDIEN; 2 ludlow parkway; chicopee MA 01022
• Manufacturer Contact: jill saraiva ; 15 hampshire street; mansfield, MA 02048 ; 5086183640
• MDR Report Key: 11913339
• Report Number: 1219103-2021-00323
• Device Sequence Number: 17253238
• Product Code: DRO
• UDI-Device Identifier: 00721902195037
• UDI-Public: 00721902195037
• Combination Product (Y/N): N
• Initial Reporter State: WA
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: User Facility,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 02/07/2022

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 Model Number: PM20003
• Device Catalogue Number: PM20003
• Device Lot Number: 004827
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 05/26/2021
• Supplement Date Received by Manufacturer: 05/26/2021
• Initial Report FDA Received Date: 06/01/2021
• Supplement Report FDA Received Date: 02/07/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: A
• Patient Sequence Number: 1
• Patient Sex: Unknown