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

Model Number PIKA

Device Problems Break (1069); Material Separation (1562)

Patient Problems Foreign Body In Patient (2687); Device Embedded In Tissue or Plaque (3165)

Event Date 07/18/2019

Event Type  Injury  

Manufacturer Narrative

The device was not returned to edwards for evaluation as it was discarded.The device history record (dhr) review could not be performed as the lot number remains unknown.Attempts to retrieve additional information were unsuccessful.If additional information is received a supplemental mdr will be submitted.The resident surgeon commented that the guidewire separation was not device related.The cause of the event cannot be determined; however, surgical technique may have contributed.The patient in this case has been discharged from the hospital.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

It was reported that a guidewire of a percutaneous insertion kit got separated at around 20cm from the tip and it remained in the patient body between the abdomen and common iliac artery during use.Although it remained in the patient, the surgeon did not notice it and the patient was discharged from the hospital.After approximately two (2) month from the surgery, the patient fell on his behind and visited the hospital again.Through the pelvic x-ray, the hospital found a foreign material, and it was also confirmed through abdominal ct scans.After approximately one (1) month from ct scans, the remained guidewire was removed by snare catheter at radiology department.The patient restored and was discharged from the hospital.

Manufacturer Narrative

Reference capa-20-00141.

• Brand Name: PERCUTANEOUS INSERTION KIT-ARTERIAL
• Type of Device: CATHETER, CANNULA AND TUBING, VASCULAR, CARDIOPULMONARY BYPASS
• Manufacturer (Section D): EDWARDS LIFESCIENCES; one edwards way; irvine CA 92614
• MDR Report Key: 9428363
• MDR Text Key: 170438604
• Report Number: 3008500478-2019-00173
• Device Sequence Number: 1
• Product Code: DWF
• Combination Product (y/n): N
• PMA/PMN Number: K140208
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup
• Report Date: 11/11/2019

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: PIKA
• Device Catalogue Number: PIKA
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 11/11/2019
• Initial Date FDA Received: 12/06/2019
• Supplement Dates Manufacturer Received: 07/23/2020
• Supplement Dates FDA Received: 09/20/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Other