MAUDE Adverse Event Report: MEDTRONIC CRYOCATH LP FLEXCATH ADVANCE STEERABLE SHEATH; CATHETER, STEERABLE

Model Number 4FC12

Device Problem Insufficient Information (3190)

Patient Problem Hematoma (1884)

Event Date 01/01/2015

Event Type  Injury  

Manufacturer Narrative

Medtronic cryocath 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 female/58 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: predictors of atrial fibrillation recurrence after cryoballoon ablation.Journal of blood medicine.2015;6:211-217.(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: hematomas, transient ischemic attack (tia), phrenic nerve palsy (pnp), and gastroparesis.No further patient complications were reported as a result of this event.Aksu t, guler te, erden i, ozcan ks, baysal e, golcuk se.Predictors of atrial fibrillation recurrence after cryoballoon ablation.Journal of blood medicine.2015;6:211-217.Objective: cryoballoon ablation (ca) is a safe and efficient method for pulmonary vein isolation in the treatment of paroxysmal atrial fibrillation (af).There are conflicting results about the predictors of af recurrence.The aim of this study is to evaluate the role of hematological indices to predict af recurrence after ca.Methods: a total of 49 patients (mean age 58.3±12.2 years, 51.02% female) with symptomatic paroxysmal af underwent ca procedure.One hundred and sixty-eight pulmonary veins were used for pulmonary vein isolation with the second-generation cryoballoon.The hematological samples were obtained before and 24 hours after ablation.Results: at a mean follow-up of 10.2±2.4 months, the probability of being arrhythmia-free after a single procedure was 86%.Patients with af recurrence had higher red cell distribution width levels (16.10%±1.44% vs 14.87%±0.48%, p=0.035).The neutrophil/lymphocyte ratio, erythrocyte sedimentation rate, and c-reactive protein levels were detected in the patients with or without recurrence.Left atrial diameter (46.28±4.30 mm vs 41.02±4.10 mm, p=0.002), duration of af (6.71±4.57 years vs 3.59±1.72 years, p=0.003), and age (65.01±15.39 years vs 54.29±11.32 years, p=0.033) were the other independent predictors of clinical recurrence after ca.Multiple regression analysis revealed that left atrial diameter was the only independent predictor for af recurrence (p=0.012).Conclusion: in t his study of patients with paroxysmal af undergoing cryoablation, increased preablation red cell distribution width levels, and not c-reactive protein or erythrocyte sedimentation rate, was associated with a higher rate of af recurrence.Our results support the role of a preablation, proinflammatory, and pro-oxidant environment in the development of af recurrence after ablation therapy but suggest that other factors are also important.

• Brand Name: FLEXCATH ADVANCE STEERABLE SHEATH
• Type of Device: CATHETER, STEERABLE
• 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: 5051645
• MDR Text Key: 24892210
• Report Number: 3002648230-2015-00265
• Device Sequence Number: 1
• Product Code: DRA
• Combination Product (y/n): N
• Reporter Country Code: TU
• PMA/PMN Number: K123591
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,l
• Reporter Occupation: Physician
• Report Date: 08/06/2015

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?: No
• Device Operator: Health Professional
• Device Model Number: 4FC12
• Device Catalogue Number: 4FC12
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/06/2015
• 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