MAUDE Adverse Event Report: ST. JUDE MEDICAL, INC. EPIC¿; HEART-VALVE, NON-ALLOGRAFT TISSUE

Model Number MITRAL

Device Problem Material Puncture/Hole (1504)

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

Event Date 11/29/2018

Event Type  malfunction  

Event Description

Epic valve was opened and passed to scrub rn who rinsed with saline and passed to field.One suture needle placed in valve when doctor requested new epic valve, same size.Per doctor, there was a "hole in the skirt".Notified another staff member and packaged valve per their instructions.Needle still in valve, valve in specimen cup and double bagged.Placed in larger bag with all packaging material and labeled with biohazard stickers.

• Brand Name: EPIC¿
• Type of Device: HEART-VALVE, NON-ALLOGRAFT TISSUE
• Manufacturer (Section D): ST. JUDE MEDICAL, INC.; 177 county road b, east; st. paul MN 55117
• MDR Report Key: 8174992
• MDR Text Key: 130691953
• Report Number: 8174992
• Device Sequence Number: 1
• Product Code: LWR
• UDI-Device Identifier: 05414734055598
• UDI-Public: (01)05414734055598(17)211129(91)100040609(30)01
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 11/30/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/18/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: MITRAL
• Device Catalogue Number: E100-29M-00
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 11/30/2018
• Event Location: Hospital
• Date Report to Manufacturer: 12/18/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 10220 DA