MAUDE Adverse Event Report: EDWARDS LIFESCIENCES PROPLEGE; CATHETER, CANNULA AND TUBING, VASCULAR, CARDIOPULMONARY BYPASS

Model Number PR9

Device Problems Detachment of Device or Device Component (2907); Appropriate Term/Code Not Available (3191)

Patient Problem Perforation (2001)

Event Date 09/18/2019

Event Type  Injury  

Manufacturer Narrative

(b)(4).Attempts to retrieve additional information are in process.The device was received by edwards for evaluation and the evaluation is currently pending.A supplemental mdr will be submitted once the evaluation has been completed.Ventricular perforation is a free perforation of the ventricle that can occur during a valve replacement.There are several potential etiologies (e.G.Guidewire or catheter).The cause of the event cannot be determined.A supplemental mdr will be submitted upon receipt of additional information.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.Udi number: (b)(4).

Event Description

Edwards received information that a catheter was inserted for a mis-mvr.While attempting to advance the catheter through the coronary sinus the catheter perforated the right ventricle.The surgeon repaired the perforation with a couple of stitches and the mis continued as planned.The patient was reported to be stable and discharged home as scheduled.Per clinical field specialist: the patient was prepped, and introducer sheaths were placed without issue.Inserted the catheter per ifu instructions with a 5000u bolus of heparin pre advancement and advanced catheter to the cs ostium.Venography performed found that the catheter was trying to engage the mcv, so we pulled back the catheter and re-advanced and the catheter popped out of the vessel, we re-engaged the cs and the catheter engaged nicely to what appeared to be a perfect placement.Upon contrast venography there was a blush of contrast that quickly dispersed so we pulled back the catheter and did another venography with the same results never any blushing causing staining.It was noticed at the third venography that there was an effusion of contrast around the heart, the catheter was left in place and the case was aborted.After further inspection the rv was found to be perforated.Surgeon noted the balloon was deflated while positioning the catheter.

Manufacturer Narrative

Device evaluation: device was returned with visible traces of blood and was examined in the biohazard area of lab.No other visual damage, contamination, or other abnormalities were found to the device.Additional manufacturer narrative: the device was returned to edwards 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.Customer report of ventricular perforation was unable to be confirmed or assessed.No edwards/supplier defect confirmed.There is no allegation of a device malfunction.The pr9 device was utilized in a case that resulted in ventricular perforation.The perforation was likely due to device manipulation while in use.A definitive root cause cannot be determined at this time.

Manufacturer Narrative

Corrected data: f10, h6.Reference capa-20-00141.

• Brand Name: PROPLEGE
• Type of Device: CATHETER, CANNULA AND TUBING, VASCULAR, CARDIOPULMONARY BYPASS
• Manufacturer (Section D): EDWARDS LIFESCIENCES; one edwards way; irvine CA 92614
• MDR Report Key: 9182685
• MDR Text Key: 173179450
• Report Number: 3008500478-2019-00161
• Device Sequence Number: 1
• Product Code: DWF
• Combination Product (y/n): N
• PMA/PMN Number: K120780
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup,Followup
• Report Date: 09/18/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/11/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 04/22/2020
• Device Model Number: PR9
• Device Catalogue Number: PR9
• Device Lot Number: 62390301
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/09/2019
• Date Manufacturer Received: 07/23/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 60 YR