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

Model Number 49260

Device Problems Break (1069); Fracture (1260)

Patient Problems No Consequences Or Impact To Patient (2199); No Patient Involvement (2645); No Known Impact Or Consequence To Patient (2692)

Event Date 07/03/2018

Event Type  malfunction  

Manufacturer Narrative

If information is provided in the future, a supplemental report will be issued.

Event Description

Medtronic received information that during use of a cardioblate gemini ablation device the electrode broke inside the patient.The detached piece was removed using thoracoscopic instruments.The device was replaced.No adverse patient effects were reported.

Manufacturer Narrative

If information is provided in the future, a supplemental report will be issued.

Manufacturer Narrative

Product analysis: visual inspection shows one of the tips is broken off.If information is provided in the future, a supplemental report will be issued.

• Brand Name: CARDIOBLATE GEMINI
• Type of Device: SURGICAL DEVICE, FOR ABLATION OF CARDIAC TISSUE
• Manufacturer (Section D): PERFUSION SYSTEMS; 7611 northland dr; brooklyn park MN 55428
• Manufacturer (Section G): PERFUSION SYSTEMS; 7611 northland dr; brooklyn park MN 55428
• Manufacturer Contact: paula bixby ; 8200 coral sea street ne; mounds view, MN 55112 ; 7635055378
• MDR Report Key: 7766507
• MDR Text Key: 117142011
• Report Number: 2184009-2018-00022
• Device Sequence Number: 1
• Product Code: OCL
• Combination Product (y/n): N
• Reporter Country Code: RS
• PMA/PMN Number: K080509
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Physician Assistant
• Type of Report: Initial,Followup,Followup
• Report Date: 10/02/2018

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: 01/30/2021
• Device Model Number: 49260
• Device Catalogue Number: 49260
• Device Lot Number: 214A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/22/2018
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 07/17/2018
• Initial Date FDA Received: 08/09/2018
• Supplement Dates Manufacturer Received: 08/22/2018; 08/08/2018
• Supplement Dates FDA Received: 09/20/2018; 10/02/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/05/2018
• 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