MAUDE Adverse Event Report: MEDFACT ENGINEERING GMBH FIRMAP CATHETER, 70MM; MAPPING CATHETER

Device Problems Difficult or Delayed Positioning (1157); Improper or Incorrect Procedure or Method (2017)

Patient Problem Cardiac Perforation (2513)

Event Type  Injury  

Event Description

Reference importer # (b)(4).

Manufacturer Narrative

A topera employee was on-site at the hospital at the time of the incident.He reported the incident to topera inc.Topera worked with the manufacturer to complete the investigation.

• Brand Name: FIRMAP CATHETER, 70MM
• Type of Device: MAPPING CATHETER
• Manufacturer (Section D): MEDFACT ENGINEERING GMBH; hammerstr. 3; lorrach D-79 540; GM D-79540
• Manufacturer Contact: jorg reinhardt ; hammerstr. 3; lorrach D-795-40 ; GM D-79540 ; 21579820
• MDR Report Key: 3764668
• MDR Text Key: 4547534
• Report Number: 3008497357-2014-00002
• Device Sequence Number: 1
• Product Code: MTD
• Combination Product (y/n): N
• PMA/PMN Number: K130827
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Distributor
• Type of Report: Initial

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/10/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Device Operator: Other
• Date Manufacturer Received: 04/09/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/01/2013
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1