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

Model Number 4700

Device Problems Crack (1135); Shipping Damage or Problem (1570); Tear, Rip or Hole in Device Packaging (2385)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 01/25/2019

Event Type  malfunction  

Manufacturer Narrative

The device was not returned to edwards for evaluation.In this case, the packaging of a patch was damaged in transit to hospital.A definitive root cause could not be determined at this time.Edwards lifesciences will continue to monitor all reported events.No further actions are required at this time.

Event Description

As reported, the packaging of a patch was damaged in transit to hospital.As reported, the box was squashed, internal container cracked and bovine pericardial patch was poking through cracked container.

Manufacturer Narrative

Device evaluation: customer report of crack and leak of a pericardial patch jar was confirmed.Patch jar was still sealed within its shrink wrapping when received.As received, the patch jar had multiple cracks on the bottom of the jar.Measurements were taken of each crack: crack a was approximately 170mm long and extended from the bottom to the side of the jar; crack b was approximately 17mm long; crack c was approximately 20mm long; crack d was approximately 13mm long; crack e was approximately 7mm long.The patch remained inside the jar and there was no solution left in jar.The patch had a crease approximately 37mm in length from being pinched by cracked jar.Photos provided from customer were consistent with lab findings.

Manufacturer Narrative

Additional manufacturer narrative: 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.

Manufacturer Narrative

Reference capa-20-00141.

• 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: 8345158
• MDR Text Key: 136891058
• Report Number: 2015691-2019-00516
• 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,Followup
• Report Date: 01/25/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/15/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 07/07/2022
• Device Model Number: 4700
• Device Catalogue Number: 4700
• Device Lot Number: 61406763
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/19/2019
• Date Manufacturer Received: 07/23/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1