MAUDE Adverse Event Report: MEDICAL CONCEPTS EUROPE B. V. TEMP PACING WIRE EPICARDIAL ADULT-PEDIATRIC BIPOLAR 60; TEMPORARY PACING WIRE, ELECTRODE, PACEMAKER

Model Number REF V060BBG

Device Problem Break (1069)

Patient Problem Foreign Body In Patient (2687)

Event Date 06/21/2018

Event Type  malfunction  

Event Description

On (b)(6) 2018, during removal of the atrial and ventricular pacing wires, one of the wires broke and there was a small retained portion within the chest that was visualized on the postop procedure chest x-ray.

• Brand Name: TEMP PACING WIRE EPICARDIAL ADULT-PEDIATRIC BIPOLAR 60
• Type of Device: TEMPORARY PACING WIRE, ELECTRODE, PACEMAKER
• Manufacturer (Section D): MEDICAL CONCEPTS EUROPE B. V. ; oost om 5422 vz gemert ; po box 53; germert 5420 AB; NL 5420 AB
• MDR Report Key: 7793144
• MDR Text Key: 117603706
• Report Number: MW5079207
• Device Sequence Number: 1
• Product Code: LDF
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 08/15/2018

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 Expiration Date: 12/13/2019
• Device Model Number: REF V060BBG
• Device Lot Number: 632096
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 08/16/2018
• 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 Outcome(s): Other
• Patient Age: 2 YR
• Patient Weight: 9