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

Model Number 4FC12

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

Patient Problem Fistula (1862)

Event Date 01/01/2019

Event Type  Injury  

Manufacturer Narrative

Concomitant medical product: arctic front advance cardiac cryoablation catheter medtronic 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 u.S.All information provided is included in this report.Patient information is limited due to confidentiality concerns.Multiple patients were noted in the article; however, a one to one correlation could not be made with unique product lot numbers.The gender of the baseline characteristics is male and the baseline age is 64 years old.The baseline weight is 64 kgs.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.A request for additional information will be made and upon receipt a supplemental report will be submitted accordingly.Referenced article: ¿multicenter study of the validity of additional freeze cycles for cryoballoon ablation in patients with paroxysmal atrial fibrillation.¿ circulation.Arrhythmia and electrophysiology.2019; 12(1):e006989.10.1161/circep.118.006989.If information is provided in the future, a supplemental report will be issued.

Event Description

The literature publication reports the following patient complications while using a cryoablation system: there were two (2) patients with pericardial tamponade/effusions: one (1) in which required drainage and one patient in which it did not.There were two (2) patients who had transient st elevation ¿presumably because of an air embolism occurred,¿ both of which resolved within ¿seconds.¿ there were eight (8) patients with transient phrenic nerve palsy (pnp), all of which resolved by ten months post-procedure.One (1) patient had ¿severe¿ pulmonary vein stenosis; with unknown treatment/resolution.Three (3) patients had hematomas or pseudoaneurysms at the puncture site; with unknown treatment/resolution.There were two (2) patients who had an arteriovenous fistula; with no treatment/resolution indicated.There was one patient who had gastric hypo-motility.The status/location of the ablation system is unknown.According to the article, "no cerebral infarctions, transient ischemic attacks, atrioesophageal fistulae, or procedure-related deaths occurred in any patient." further follow up did not yet yield any additional information.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; 9000 autoroute transcanadienne; pointe-claire,qc H9R 5 Z8; CA H9R 5Z8
• Manufacturer (Section G): MEDTRONIC CRYOCATH LP; 9000 autoroute transcanadienne; pointe-claire,qc H9R 5 Z8; CA H9R 5Z8
• Manufacturer Contact: lisa robertson ; 8200 coral sea st ne; mounds view, MN 55112 ; 7635262723
• MDR Report Key: 8348561
• MDR Text Key: 136502162
• Report Number: 3002648230-2019-00118
• Device Sequence Number: 1
• Product Code: DRA
• Combination Product (y/n): N
• Reporter Country Code: JA
• 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: 02/18/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/18/2019
• 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: 01/22/2019
• 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
• Patient Age: 64 YR
• Patient Weight: 64