MAUDE Adverse Event Report: EDWARDS LIFESCIENCES EDWARDS PERICARDIAL PATCH; PATCH, PLEDGET AND INTRACARDIAC, PETP, PTFE, POLYPROPYLENE

Model Number 4700J

Device Problem Packaging Problem (3007)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 10/22/2021

Event Type  malfunction  

Manufacturer Narrative

The device has not yet been returned for evaluation.Device is currently believed to be in transit to edwards lifesciences for evaluation.A supplemental mdr will be submitted as soon as additional information is received.The cause of the event cannot be determined at this time.Edwards will continue to review and monitor all events.Trends are monitored on a monthly basis and if action is required, appropriate investigation will be performed.

Event Description

Edwards received information that the glutaraldehyde solution leakage on this 4700 pericardial patch before use.There was no problem confirmed when the customer received the device from a dealer, and the device was stored in an incubator at the hospital.After two (2) days, it was confirmed that the shelf box was wet when the device was taken from the incubator.The jar was not dropped nor damaged at the hospital.

Manufacturer Narrative

H3.Device evaluation: customer report of glutaraldehyde solution leakage was confirmed.The device was received in opened shelf box packaging with plastic sleeve.Tamper seal of the jar was broken.The tagalert display was blank.Patch remained inside the jar with no glutaraldehyde solution.The patch appeared wet and intact.The jar was observed to have multiple cracks on the bottom of the jar.At the bottom of the jar five cracks measured 1.1"(a), 0.82"(b), 0.61"(c), 0.78"(d), 1.1"(e).Crack (a) appeared to extend to the side of the jar and measured 3.4"(f).

Manufacturer Narrative

Damage to the package/product is most likely the result of mechanical damage incurred while in the care of the customer or in transit from the courier, and not an indication of a device malfunction.

• Brand Name: EDWARDS PERICARDIAL PATCH
• Type of Device: PATCH, PLEDGET AND INTRACARDIAC, PETP, PTFE, POLYPROPYLENE
• Manufacturer (Section D): EDWARDS LIFESCIENCES; one edwards way; irvine CA 92614
• Manufacturer (Section G): EDWARDS LIFESCIENCES; one edwards way; irvine CA 92614
• Manufacturer Contact: reginald santos ; 1 edwards way; irvine, CA 92614 ; 9492502731
• MDR Report Key: 12817657
• MDR Text Key: 281205085
• Report Number: 2015691-2021-06313
• Device Sequence Number: 1
• Product Code: DXZ
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K082139
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 01/21/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/15/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Model Number: 4700J
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/22/2021
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 01/21/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/23/2021
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1