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

Model Number 60832

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Cardiac Tamponade (2226)

Event Date 10/01/2010

Event Type  Injury  

Manufacturer Narrative

The product has not been received by medtronic and the investigation is in progress.Without the return of the product, no definitive conclusion can be made regarding the clinical observation.The return of the product and relationship of the device and patient impact have been requested.Should the product be returned, additional information received, or if the completed investigation yields new information, a follow up report will be submitted.Citation: pires, leonardo m., tiago l.L.Leiria, gustavo g.De lima, marcelo l.Kruse, ivo a.Nesralla, and renato a.K.Kalil."comparison of surgical cut and sew versus radiofrequency pulmonary veins isolation for chronic permanent atrial fibrillation: a randomized study." pacing and clinical electrophysiology 33.10 (2010): 1249-257.Web.Earliest date of publish used for event date.No unique device identifier (serial/lot) numbers were provided; without this information it could not be determined whether these observations have been previously reported.

Event Description

Medtronic received information via literature regarding the efficacy of electrical block lines performed with radiofrequency (rf) compared with conventional surgery to restore sinus rhythm (sr) in patients with chronic permanent atrial fibrillation (cpaf) and mitral valve disease.All data were collected from the instituto de cardiologia do rio grande do sul/fundac¸ao¿ universitaria de cardiologia from november 2005 to february 2007.The study population included 22 patients (equal male/female participants, mean age 59.3 years), 12 of which were randomized to the rf technique using the medtronic cardioblate surgical ablation probe and system (serial numbers not provided).Among all patients zero deaths occurred.Among all patients in the rf technique group adverse events included: a female patient whom presented with cardiac tamponade requiring surgical intervention.Based on the available information, this event may have been attributed to medtronic product.Additional information was requested.Among all patients, no device malfunctions were noted.No additional adverse patient effects or product performance issues were reported.

Manufacturer Narrative

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

Manufacturer Narrative

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

• Brand Name: CARDIOBLATE
• 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: 6667049
• MDR Text Key: 78391655
• Report Number: 2184009-2017-00022
• Device Sequence Number: 1
• Product Code: OCL
• Combination Product (y/n): N
• Reporter Country Code: BR
• PMA/PMN Number: K093203
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,l
• Reporter Occupation: Health Professional
• Type of Report: Initial,Followup,Followup
• Report Date: 11/16/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 60832
• Device Catalogue Number: 60832
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 06/05/2017
• Initial Date FDA Received: 06/26/2017
• Supplement Dates Manufacturer Received: 06/05/2017; 06/05/2017
• Supplement Dates FDA Received: 09/29/2017; 11/16/2017
• Was Device Evaluated by Manufacturer?: No
• 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): Life Threatening; Required Intervention