MAUDE Adverse Event Report: EDWARDS LIFESCIENCES PERCUTANEOUS INSERTION KIT-ART; CATHETER, CANNULA AND TUBING, VASCULAR, CARDIOPULMONARY BYPASS

Model Number PIKA

Device Problems Break (1069); Difficult to Remove (1528)

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

Event Date 11/11/2020

Event Type  malfunction  

Manufacturer Narrative

Device evaluation: customer complaint of dilator removal difficulty was unable to be confirmed or assessed.Od measurement of dilator was 0.205", which was in specification.As received, the dilator had multiple surface cuts at the distal tip.No other visible damage, contamination, or other abnormalities were observed from returned device.Additional manufacturer narrative: the device was returned for evaluation.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.It was reported that resistance was felt when the dilator was removed from the patient during use.The purpose of the dilator is to create a path through the subcutaneous tissue to allow placement of a percutaneous arterial or venous cannula.This is done prior to the initiation of the bypass.Difficulty to remove the dilator typically could result from anatomic variations and may require manipulation of the dilator for removal with minimal delay and risk to the patient.In this case, product evaluation demonstrated multiple surface cuts at the distal tip of the dilator.It is unknown if the cuts existed before use or they were caused by a sharp instrument after pulling the dilator out of the patient.Based on the information received the cause of the event cannot be determined.If additional information is received a supplemental mdr will be submitted.Trend was reviewed and found to be in control.No further corrective or preventative actions are required at this time.Edwards lifesciences will continue to monitor all reported events.

Event Description

It was reported that resistance was felt when the dilator was removed from the patient during use.There was no resistance felt when the dilator was inserted to the patient.There was no abnormalities observed to the dilator or the cannula.The device was stored vertically at the hospital.There was no patient complications occurred.

Event Description

Additional information received indicated that the inspection was not performed carefully and the surface cuts were not noticed before use.It is unknown how the surface cuts were made.No patient complications occurred owing to the device.

• Brand Name: PERCUTANEOUS INSERTION KIT-ART
• Type of Device: CATHETER, CANNULA AND TUBING, VASCULAR, CARDIOPULMONARY BYPASS
• Manufacturer (Section D): EDWARDS LIFESCIENCES; 1 edwards way; irvine CA 92614
• MDR Report Key: 11323151
• MDR Text Key: 233085103
• Report Number: 3008500478-2021-00219
• Device Sequence Number: 1
• Product Code: DWF
• Combination Product (y/n): N
• PMA/PMN Number: K123303
• 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: 11/11/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/12/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: PIKA
• Device Catalogue Number: PIKA
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/03/2020
• Date Manufacturer Received: 02/15/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1