MAUDE Adverse Event Report: EDWARDS LIFESCIENCES EDWARDS BOVINE PERICARDIAL PATCH, MODEL 4700; PATCH, PLEDGET AND INTRACARDIAC, PETP, PTFE, POLYPROPYLENE

Model Number 4700

Device Problems Moisture Damage (1405); Tear, Rip or Hole in Device Packaging (2385)

Patient Problems No Patient Involvement (2645); No Known Impact Or Consequence To Patient (2692)

Event Date 06/24/2020

Event Type  malfunction  

Manufacturer Narrative

Additional manufacturer narrative: the device has not been returned to edwards for evaluation.Attempts to retrieve the device is in process.The device history record (dhr) was reviewed and shows that this device met all manufacturing specifications for product release prior to distribution.No issues were identified that would have impacted this event.The cause of the event cannot be determined at this time.If additional information is received a supplemental mdr will be submitted.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 shelf box around the jar containing the pericardial patch was found wet at preparation before use.The glutaraldehyde solution leakage was suspected.The shrink wrap around the shelf box was opened.The shelf box was not opened and the device was not used.

Manufacturer Narrative

Corrected data: f10, h6.Reference (b)(4).

Manufacturer Narrative

H3.Device evaluation: customer report of glutaraldehyde solution leakage was confirmed.The device was received in its original sealed packaging.The jar was observed to have multiple cracks on the bottom of the jar with two cracks extended on the side of the jar.At the bottom of the jar seven cracks measured 1.65"(a), 0.27"(b), 1.45"(c), 0.78"(d), 0.59"(e), 0.74"(f), and 0.62"(g).Crack(i) ran lengthwise on the side of the jar by approximately 0.78" and crack(h) at 1.53".The patch remained inside of the jar.The glutaraldehyde solution had leaked out of the jar, and was contained by a plastic bag as received.The tagalert was blank; water damage was observed on the display.The tag alert start button was pushed and the tag alert remained blank.H10.Additional manufacturer narrative: the complaint was confirmed.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.The cause of the event cannot conclusively be determined.

• Brand Name: EDWARDS BOVINE PERICARDIAL PATCH, MODEL 4700
• Type of Device: PATCH, PLEDGET AND INTRACARDIAC, PETP, PTFE, POLYPROPYLENE
• Manufacturer (Section D): EDWARDS LIFESCIENCES; one edwards way; irvine CA 92614
• MDR Report Key: 10283683
• MDR Text Key: 199833149
• Report Number: 2015691-2020-12537
• 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,Followup
• Report Date: 06/24/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/16/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 02/03/2024
• Device Model Number: 4700
• Device Catalogue Number: 4700
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/24/2020
• Date Manufacturer Received: 07/23/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1