MAUDE Adverse Event Report: EDWARDS LIFESCIENCES FEM-FELX, FEX-FLEX II FEMORAL ACCESS CANNULA WITH DURAFLO COATING; CATHETER, CANNULA AND TUBING, VASCULAR, CARDIOPULMONARY BYPASS

Model Number PIKA

Device Problems Delivered as Unsterile Product (1421); Shipping Damage or Problem (1570); Tear, Rip or Hole in Device Packaging (2385)

Patient Problem No Patient Involvement (2645)

Event Date 04/23/2019

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Any packaging non-conformance that results in a breach of the sterile package (i.E.Pinhole, tear or seal issue), has the potential to result in a serious infection.In this case, minimal information regarding this event was received.The root cause of this event cannot be conclusively determined with the available information.The subject device was not returned for evaluation.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 notification that five (5) units of pika devices were received at the hospital with outer packaging and products damaged.As reported, one of the items did have a sterility breach as there was a puncture to the packaging.The damaged to the exterior box was immediately noticed by the customer when the products were delivered.

Manufacturer Narrative

The device history record (dhr) review was completed and this device passed all manufacturing and sterilization inspections prior to release for distribution.There were no issues identified that would have impacted this event.

Manufacturer Narrative

H3: evaluation summary: four out of the five alleged devices were returned.Per evaluation of the four returned devices, customer report of damaged packaging was confirmed.There was no breach to the sterile barriers.Wrinkled labeling was apparent on the brown corrugated packaging box.As received, the shelf boxes of the returned devices were found damaged with multiple creases and dents.No other visible damage, contamination, or other abnormalities were observed from returned devices.Photos attached by complaint handler appeared consistent with lab findings.It should be noted that the alleged sterility breach was noted on the device that was not returned.However, without a device to evaluate, a sterility breach could not be confirmed.H10: additional manufacturer narrative: updated sections d10, h3, h6 h11: corrected data: updated section h10 (additional manufacturer narrative) any packaging non-conformance that results in a breach of the sterile package (i.E.Pinhole, tear or seal issue), has the potential to result in a serious infection.In this case, the damaged noted on the external box is consistent with damage incurred during transfer/shipment.However, a definitive root cause could not be identified.Pika shelf and shipping cartons are visually inspected for damage upon receipt, as well as prior to sterilization.Additionally, any box damage would have likely been noted during assembly and packaging at edwards.Per the instructions for use (ifu), "do not use if device shows signs of damage (i.E., cuts, kinks, crushed areas), or if package is damaged or open." additionally, device packaging states, ¿do not use if package is damaged.¿ the device history record (dhr) review was completed and this device passed all manufacturing and sterilization inspections prior to release for distribution.There were no issues identified that would have impacted this event.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.

Manufacturer Narrative

Reference capa-20-00141.

• Brand Name: FEM-FELX, FEX-FLEX II FEMORAL ACCESS CANNULA WITH DURAFLO COATING
• Type of Device: CATHETER, CANNULA AND TUBING, VASCULAR, CARDIOPULMONARY BYPASS
• Manufacturer (Section D): EDWARDS LIFESCIENCES; 1 edwards way; irvine CA 92614
• MDR Report Key: 8653885
• MDR Text Key: 146961863
• Report Number: 3008500478-2019-00137
• Device Sequence Number: 1
• Product Code: DWF
• Combination Product (y/n): N
• PMA/PMN Number: K123298
• 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: 04/23/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/30/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 11/27/2021
• Device Model Number: PIKA
• Device Catalogue Number: PIKA
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/08/2019
• Date Manufacturer Received: 07/23/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1