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

Model Number 4FC12

Device Problem Insufficient Information (3190)

Patient Problem Cardiac Tamponade (2226)

Event Date 10/01/2015

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/(b)(6).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: adenosine triphosphate test after cryothermal pulmonary vein isolation: creating contiguous lesions is essential for eliminating dormant conduction.Journal of cardiovascular electrophysiology,.2015;26(10):1069-1074.(b)(4).

Event Description

Miyazaki smd, taniguchi h, nakamura h, et al.Adenosine triphosphate test after cryothermal pulmonary vein isolation: creating contiguous lesions is essential for eliminating dormant conduction.Journal of cardiovascular electrophysiology,.2015;26(10):1069-1074.Dormant conduction after cryothermal pvi background adenosine triphosphate (atp) testing reveals dormant pulmonary vein (pv) conduct ion after electrical pv isolation (pvi).This study aimed to evaluate the incidence of latent pv conduction after cryothermal pvi.Methods fifty-four consecutive paroxysmal atrial fibrillation patients undergoing cryothermal pvi were prospectively enrolled.Pvi was performed with one 28-mm second-generation balloon using a 3-minute freeze technique, and touch-up lesions were created by focal cryothermal applications.Atp testing was performed following pvi with a 20-mm circular mapping catheter placed in each pv.Results of 217 pvs, 205 (94.5%) were isolated using a cryoballoon, and 12 required additional focal ablation.Atp testing was performed in 46 patients for 173 and 8 pvs, which were isolated by cryoballoons and focal ablation, respectively.No dormant pv conduction was provoked in any pvs, which were isolated by cryoballoons, whereas 4 (50.0%) out of 8 pvs requiring focal ablation had transient atp-provoked reconnections (0 vs.50.0%, p <(><<)> 0.0001) with a median duration of 11.3 (10.7-17.1) seconds.The latent pv conduction site was identical to the residual conduction gap site after cryoballoon ablation in all.All latent conduction was successfully eliminated by 2 (2.0-9.5) additional focal applications.At a mean follow-up of 7.7 ᠱ.6 months, 81.5% of the patients were arrhythmia free after a single procedure.Conclusions no dormant pv conduction was provoked in pvs, which were isolated by 28-mm second generation cryoballoons, but was provoked in 50% of pvs, which were isolated by focal cryoablation.These findings suggest that creating contiguous lesions is essential for eliminating dormant conduction in cryothermal ablation.The literature publication reports the following patient complications: one patient experienced cardiac tamponade which required per i-cardiocentesis; one patient experienced phrenic nerve injury (pni); one patient experienced pneumothorax.

• 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: 5251427
• MDR Text Key: 32182326
• Report Number: 3002648230-2015-00423
• Device Sequence Number: 1
• Product Code: DRA
• Combination Product (y/n): N
• Reporter Country Code: JA
• 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

• Date FDA Received: 11/25/2015
• 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
• Date Manufacturer Received: 11/09/2015
• 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: 00062 YR