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

Model Number 4700

Device Problems Use of Device Problem (1670); Appropriate Term/Code Not Available (3191)

Patient Problems Chemical Exposure (2570); Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Date 07/05/2021

Event Type  Injury  

Manufacturer Narrative

Additional manufacturer narrative: in this case, it was reported that the glutaraldehyde solution got into the customer's eye.Eye contact with glutaraldehyde liquid may result in serious eye irritation and/or damage.Request for additional information has been performed; however, the healthcare provider has not provided any additional details regarding this event.The reported event cannot be confirmed with the available information.The root cause of this event remains indeterminable.The subject device was not returned for evaluation as the product status is unknown.The device history record (dhr) could not be reviewed, as the device serial number was not provided.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.If new information becomes available, a supplemental report will be submitted.

Event Description

Edwards received information that the glutaraldehyde solution of a 4700 pericardial patch got into the customer's eye.It did not lead to a serious injury.It was unknown when the event occurred and whether or not the patch was used for the surgery.No other details were provided.

Manufacturer Narrative

H10: additional manufacturer narrative: updated section h6 (investigation conclusions).Corrected section h6 (health effect - clinical code, device codes).

• Brand Name: EDWARDS PERICARDIAL PATCH
• Type of Device: PATCH, PLEDGET AND INTRACARDIAC, PETP, PTFE, POLYPROPYLENE
• Manufacturer (Section D): EDWARDS LIFESCIENCES; 1 edwards way; irvine CA 92614
• MDR Report Key: 12233879
• MDR Text Key: 264130846
• Report Number: 2015691-2021-04365
• Device Sequence Number: 1
• Product Code: DXZ
• Combination Product (y/n): N
• PMA/PMN Number: K082139
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 09/08/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 4700
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 07/05/2021
• Initial Date FDA Received: 07/27/2021
• Supplement Dates Manufacturer Received: 09/07/2021
• Supplement Dates FDA Received: 09/08/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other