MAUDE Adverse Event Report: MEDTRONIC CRYOCATH LP FREEZOR MAX CARDIAC CRYOABLATION CATHETER; PERCUTANEOUS CATHETER INTENDED FOR TREATMENT OF ATRIAL FIBRILLATION

Model Number 209F3

Device Problem Difficult To Position (1467)

Patient Problem No Code Available (3191)

Event Type  Injury  

Manufacturer Narrative

Medtronic (b)(4) was made aware of this event through a search of literature publications.It was not possible to ascertain specific device information from the literature publication or to match the event with previously reported events.This information is based entirely on journal literature.This event occurred outside the us.All information provided is included in this report.Patient information is limited due to confidentiality concerns.The baseline gender/age is male/(b)(6) years old.Without a lot number or device serial number, the manufacturing date cannot be determined.Since no device id was provided, it is unknown if this event has been previously reported.Referenced article: comparison of 'anatomically designed' and 'pointby-point' catheter ablations for human atrial fibrillation in terms of procedure timing and costs in german hospitals.Europace.2015;17(7):1030-1037.(b)(4).

Event Description

A journal article was received which contained information regarding cardiac ablation sheaths and catheters.Multiple patients were noted in the article; however, a one to one correlation could not be made with unique device serial numbers.The literature publication reports the following complications: pericardial effusion, hematoma, and difficulty positioning the catheter which resulted in longer procedure time.The status of the product is unknown.No further patient complications have been reported as a result of this event.Klein g, lickfett l, schreieck j, et al.Comparison of 'anatomically designed' and 'pointby-point' catheter ablations forhuman atrial fibrillation in terms of procedure timing and costs in german hospitals.Europace.2015;17(7):1030-1037.Aims the purpose of the fast-pvi study was to compare 'traditional' ablation tools based on 'point-by-point' technology with the new 'anatomically designed' technologies in terms of procedure times and related costs for the treatment of paroxysmal atrial fibrillation.Methods and results four hundred and fifty-two consecutive ablation procedures (222 'anatomically designed', 136 arctic front<(><<)>sup>><<)>/sup> and 86 pvac<(><<)>sup>> <<)>/sup>) and 230 'point-by-point' ablations (100 carto xp and 130 navx navigation systems) performed by nine university centres across germany from 2006 to 2010 were evaluated retrospectively.Staffing and resources times for each procedure were documented together with patient morbidities, complications, and pulmonary veins isolations.On the basis of drg data from 2006 to 2010, human resources use and equipment maintenance costs were assigned to ablation procedure and calendar year.All procedural times were significantly higher in 'point-by-point' technologies compared with 'anatomically designed' ablations [average lab occupancy time 185.30 vs.280.28 min; physician time 152.21 vs.238.04 min; support time 183.43 vs.278.34 min and fluoroscopy time 29.11 vs.40.72 min; p <(><<)> 0.001 (95% confidence interval, ci)].For each ablation procedure human resource use per operating minute resulted in lower costs for 'anatomically designed' ablations [(b)(4)].Savings due to reduced duration in 'anatomically designed' technologies accrued to (b)(4)lower human resource costs.Sensitivity analyses did not lead to any significant variations on the outcomes parameter cost per minute.Conclusion fast-pvi showed reductions in ablation procedural time may lead to increased hospital capacity and non-device-related cost-savings, while maintaining quality.

• Brand Name: FREEZOR MAX CARDIAC CRYOABLATION CATHETER
• Type of Device: PERCUTANEOUS CATHETER INTENDED FOR TREATMENT OF ATRIAL FIBRILLATION
• Manufacturer (Section D): MEDTRONIC CRYOCATH LP; 16771 chemin ste-marie; kirkland H9H 5 H3; CA H9H 5H3
• Manufacturer (Section G): MEDTRONIC CARDIAC RHYTHM HEART FAILURE; 8200 coral sea st ne; mounds view MN 55112
• Manufacturer Contact: anne schilling ; 8200 coral sea st ne; mounds view, MN 55112 ; 7635052036
• MDR Report Key: 5051915
• MDR Text Key: 24902263
• Report Number: 3002648230-2015-00269
• Device Sequence Number: 1
• Product Code: OAE
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: P100010
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,l
• Reporter Occupation: Physician
• Report Date: 08/05/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/02/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 209F3
• Device Catalogue Number: 209F3
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/05/2015
• 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): Hospitalization; Required Intervention
• Patient Age: 00058 YR