MAUDE Adverse Event Report: EDWARDS LIFESCIENCES RETROGRADE CARDIOPLEGIA CATHETER BALLOON; CATHETER, CANNULA AND TUBING, VASCULAR

Model Number RC2012

Device Problems Material Puncture/Hole (1504); Component Missing (2306); Defective Device (2588)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 09/21/2018

Event Type  malfunction  

Event Description

Upon completion of surgical case, retrograde cardioplegia cannula (edwards lifesciences (b)(4)) found to be defective, hole noted in balloon with piece missing.Unk if piece in pt or not.

• Brand Name: RETROGRADE CARDIOPLEGIA CATHETER BALLOON
• Type of Device: CATHETER, CANNULA AND TUBING, VASCULAR
• Manufacturer (Section D): EDWARDS LIFESCIENCES; one edwards way; irvine CA 92614
• MDR Report Key: 7979101
• MDR Text Key: 124500528
• Report Number: MW5080654
• Device Sequence Number: 1
• Product Code: DWF
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: No Information
• Type of Report: Initial

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: RC2012
• Device Catalogue Number: RC2012
• Device Lot Number: 61339985
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 10/17/2018
• Was Device Evaluated by Manufacturer?: No Information
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 76 YR
• Patient Weight: 77