MAUDE Adverse Event Report: MEDTRONIC PERFUSION SYSTEMS CARDIOBLATE GEMINI; SURGICAL DEVICE, FOR ABLATION OF CARDIAC TISSUE

Model Number 49260

Device Problem Detachment of Device or Device Component (2907)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 05/19/2014

Event Type  malfunction  

Event Description

Medtronic received information indicating that during ablation, as the surgeon was repositioning this cardioblate gemini and removing the cables from the device, the connector on the top jaw became disconnected.The device was replaced and the procedure was completed with no adverse patient effects reported.The product was returned for analysis.

Manufacturer Narrative

Upon receipt at medtronic's quality laboratory, visual inspection confirmed that the hooded shroud was missing.The hooded shroud was returned with the device.The sheath was observed under magnification, and there appeared to be adhesive residue on it.Medtronic's quality engineers could not identify the root cause of the event, as there was evidence of adhesive on the sheath of the device where the shroud was attached.These products are 100% inspected prior to release for distribution.There are no trends associated with this issue.(b)(4).

• Brand Name: CARDIOBLATE GEMINI
• Type of Device: SURGICAL DEVICE, FOR ABLATION OF CARDIAC TISSUE
• Manufacturer (Section D): MEDTRONIC PERFUSION SYSTEMS; 7611 northland dr; brooklyn park MN 55428
• Manufacturer (Section G): MEDTRONIC STRUCTURAL HEART; 8200 coral sea street ne; mounds view MN 55112
• Manufacturer Contact: paula bixby ; 8200 coral sea street ne; mounds view, MN 55112 ; 7635055378
• MDR Report Key: 3872723
• MDR Text Key: 20857058
• Report Number: 2184009-2014-00042
• Device Sequence Number: 1
• Product Code: OCL
• Combination Product (y/n): N
• Reporter Country Code: EZ
• PMA/PMN Number: K080509
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,User Facility,Company Representative
• Reporter Occupation: Health Professional
• Type of Report: Initial
• Report Date: 05/19/2014

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: 04/30/2015
• Device Model Number: 49260
• Device Catalogue Number: 49260
• Device Lot Number: Q516
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/28/2014
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 05/19/2014
• Initial Date FDA Received: 06/13/2014
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/10/2012
• 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