MAUDE Adverse Event Report: ST. JUDE MEDICAL ENSITE¿ PRECISION¿ SURFACE ELECTRODE KIT; ELECTROPHYSIOLOGY CARDIAC MAPPING SYSTEM

Model Number EN0020-P

Device Problem Difficult to Remove (1528)

Patient Problem Tissue Damage (2104)

Event Date 04/19/2017

Event Type  Injury  

Manufacturer Narrative

The results of the investigation are inconclusive since the device was not returned for analysis.Based on the information received, the cause of the reported skin tear could not be conclusively determined.A review of the device history record of inspection results for this lot number confirmed that no nonconformances were identified related to the reported event and the product met abbott specifications.

Event Description

During a right atrial flutter ablation procedure a skin tear occurred.The system reference patch was placed on the right, midline axillary region and no skin preparation was performed.The case was completed and when the patch was removed, a skin tear was noted beneath the patch.The skin was treated with a bandage and there were no further issues.

• Brand Name: ENSITE¿ PRECISION¿ SURFACE ELECTRODE KIT
• Type of Device: ELECTROPHYSIOLOGY CARDIAC MAPPING SYSTEM
• Manufacturer (Section D): ST. JUDE MEDICAL; parque industrial, zona franca coyol s.a.; edificio #44b, calle 0, avenida 2, coyol; alajuela, costa rica 1897- 4050; CS 1897-4050
• Manufacturer (Section G): ST. JUDE MEDICAL; parque industrial, zona franca coyol s.a.; edificio #44b, calle 0, avenida 2, coyol; alajuela, costa rica 1897- 4050; CS 1897-4050
• Manufacturer Contact: denise johnson ; 5050 nathan lane north; plymouth, MN 55442 ; 6517564470
• MDR Report Key: 6558550
• MDR Text Key: 74859320
• Report Number: 3008452825-2017-00096
• Device Sequence Number: 1
• Product Code: DQK
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K160186
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 05/10/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/10/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 07/31/2017
• Device Model Number: EN0020-P
• Device Lot Number: 5870311
• Other Device ID Number: 05415067025937
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/19/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/21/2017
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other