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 characteristics of the patients referenced in the article is gender/age is male/49 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: the impact of cryoballoon-based catheter ablation on left atrial structural and potential electrical remodeling in patients with paroxysmal atrial fibrillation.J.Intervent.Card.Electrophysiol.2015;44(2):131-139.(b)(4).

Event Description

Canpolat u, aytemir k, ozer n, oto a.The impact of cryoballoon-based catheter ablation on left atrial structural and potential electrical remodeling in patients with paroxysmal atrial fibrillation.J.Intervent.Card.Electrophysiol.2015;44(2):131-139.Background: while atrial fibrillation (af) begets af via structural, contractile, and electrical remodeling, it was shown that successful radiofrequency ablation of af has effectively reversed left atrial (la) remodeling.However, there was little data regarding the efficacy of cryoablation on la remodeling.Herein, we aimed to assess the impact of cryoablation on la structural and potential electrical remodeling in paroxysmal af patients.Methods: a total of 41 symptomatic patients with nonvalvular paroxysmal af underwent their first catheter ablation via cryoballoon technique.All patients had transthoracic echocardiography before, 6 and 12 months after cryoablation.La volume index (lavi), left intra-, right intra-, and inter-atrial electromechanical conduction delay (aemd) were calculated in all patients.Postprocedural first 3 months was accepted as blanking period.Results: all 179 pulmonary veins were isolated successfully in 41 patients with no major complication.During median 18 months (12-20 months) follow-up, recurrent atrial arrhythmia was found in nine patients (21.9 %).In multivariate cox regression analysis, only early recurrence was found as the independent predictor of late recurrence.At 12th month visit compared to baseline, there was no change in lavi (p = 0.647) but significant increase in left intra- and inter-aemd (p <(><<)> 0.05).However, in non-recurrent group, both lavi (30.63 ᠳ.6 to 28.42 ᠳ.63, p <(><<)> 0.001), left intra-aemd (18.75 ᠸ.77 to 12.5 ᠴ.65, p <(><<)> 0.001), and inter-aemd (25.2 ᠱ3.2 to 18.84 ᠸ.52, p <(><<)> 0.001) were significantly decreased.Conclusions: our study findings revealed that successful cryoballoon-based af ablation yields la structural and potential electrical reverse remodeling.However, la remodeling process cannot be halted by cryoablation in patients with af recurrence during follow-up.The literature publication reports the following patient complications: there were two patients who experienced "minimal inguinal hematomas." these were "managed conservatively." no further patient complications have been reported as a result of this event.

• 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: 5247685
• MDR Text Key: 32097933
• Report Number: 3002648230-2015-00419
• 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
• Type of Report: Initial
• Report Date: 11/09/2015

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: Physician
• Device Model Number: 4FC12
• Device Catalogue Number: 4FC12
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 11/09/2015
• Initial Date FDA Received: 11/24/2015
• 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): Required Intervention
• Patient Age: 00049 YR