MAUDE Adverse Event Report: EDWARDS LIFESCIENCES PROPLEGE CORONARY SINUS CATHETER MODEL PR9; CATHETER, CANNULA AND TUBING, VASCULAR, CARDIOPULMONARY BYPASS

Model Number PR9

Device Problems Inflation Problem (1310); No Flow (2991)

Patient Problems No Consequences Or Impact To Patient (2199); No Known Impact Or Consequence To Patient (2692)

Event Date 12/06/2019

Event Type  malfunction  

Manufacturer Narrative

The device has not been returned to edwards for evaluation.Attempts to retrieve the device and additional information are in process.Based on the information received the cause cannot be determined.A supplemental mdr will be submitted as new information becomes available.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 notification that issues were experienced while preparing the blue lumen of this catheter.As reported, using saline only, the operator inflated with abnormal force the balloon.But then, the volume was not able to be taken back.The lumen was blocked.The catheter was not used on the patient.A new catheter was opened to do the procedure.

Manufacturer Narrative

Customer complaint of balloon deflation difficulty and occlusion was confirmed.As received, device exhibited a permanent curve consistent with other pr9 devices returned in decontamination bags.As received, the balloon inflation lumen was found to be occluded and could not be cleared.All other through lumens were found to be patent without any leakage or occlusion.No visual damage, contamination, or other abnormalities were found.The device history record (dhr) was reviewed and showed that this device met all manufacturing and sterilization specifications for product release prior to distribution.No issues were 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: PROPLEGE CORONARY SINUS CATHETER MODEL PR9
• Type of Device: CATHETER, CANNULA AND TUBING, VASCULAR, CARDIOPULMONARY BYPASS
• Manufacturer (Section D): EDWARDS LIFESCIENCES; one edwards way; irvine CA 92614
• MDR Report Key: 9539338
• MDR Text Key: 207056114
• Report Number: 3008500478-2020-00182
• Device Sequence Number: 1
• Product Code: DWF
• Combination Product (y/n): N
• PMA/PMN Number: K12078024
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup,Followup
• Report Date: 12/09/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/02/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 06/12/2020
• Device Model Number: PR9
• Device Catalogue Number: PR9
• Device Lot Number: 62487643
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/10/2020
• Date Manufacturer Received: 07/23/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other