MAUDE Adverse Event Report: OSCOR INC. TEMPORARY MYOCARDIAL HEARTWIRE; ELECTRODE, PACEMAKER, TEMPORARY

Model Number TME 64 S

Device Problem Physical Resistance/Sticking (4012)

Patient Problem Insufficient Information (4580)

Event Date 06/27/2022

Event Type  malfunction  

Event Description

Pacer wires were being removed at the bedside; atrial wire removed without issue, provider met resistance with ventricular pacer wire, asked for additional help from surgeon.Surgeon was able to remove the wire but noted it appeared incomplete in comparison to atrial wire after removal.Imaging taken to confirm.Decision was made to leave wire fragment in place.Ultrasound completed.

• Brand Name: TEMPORARY MYOCARDIAL HEARTWIRE
• Type of Device: ELECTRODE, PACEMAKER, TEMPORARY
• Manufacturer (Section D): OSCOR INC.; 3816 desoto blvd; palm harbor FL 34683
• MDR Report Key: 15074676
• MDR Text Key: 296308664
• Report Number: 15074676
• Device Sequence Number: 1
• Product Code: LDF
• 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: 06/30/2022

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: TME 64 S
• Device Catalogue Number: 2G-87-272Z-X-08
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 06/30/2022
• Event Location: Hospital
• Date Report to Manufacturer: 07/21/2022
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 07/21/2022
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Age: 300 DA
• Patient Sex: Male
• Patient Weight: 7 KG