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

Model Number 3FC12

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

Patient Problems Fistula (1862); Hematoma (1884); Cardiac Tamponade (2226); Vascular System (Circulation), Impaired (2572); Pseudoaneurysm (2605)

Event Date 01/01/2019

Event Type  Injury  

Manufacturer Narrative

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 us.All information provided is included in this report.Patient information is limited due to confidentiality concerns.The baseline gender/age of the patients represented in the article is male/60 years old.Of note, multiple patients/multiple methods/multiple manufacturers were noted in the article; however, a one to one correlation could not be made with unique product lot/serial numbers/methods/manufacturers.The model listed in the report is a representative of the model family, as there is no specific model listed.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: ¿updated national multicenter registry on procedural safety of catheter ablation for atrial fibrillation.¿ journal of cardiovascular electrophysiology.2013; 24(10):1069-1074.Doi:// 10.1111/jce.12194.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 balloon/sheath catheter/phased radio frequency ablation catheter: in 94 patients: ¿vascular access complications (28 femoral hematoma, 13 arteriovenous fistula, 7 femoral pseudoaneurysm, and two (2) subclavian hematomas); 12 patients developed cardiac tamponade, successfully drained in all cases; 14 patients presented with pericarditis; five (5) patients had transient ischemic attack; four (4) patients had stroke (three (3) ischemic and one (1) hemorrhagic); three (3) patients had phrenic nerve paralysis during right pulmonary vein (pv) isolation; three (3)patients had hemothorax that required drainage in two (2).Other isolated but serious adverse events were documented in three (3) patients; stenosis >50% in one (1); sinus bradycardia that required transient cardiac stimulation in one (1).¿ the status/location of the cryoballoon catheter/sheath catheter/phased radio frequency ablation catheter is unknown.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 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: paula bixby ; 8200 coral sea st ne; mounds view, MN 55112 ; 7635055378
• MDR Report Key: 9077761
• MDR Text Key: 162998552
• Report Number: 3002648230-2019-00665
• Device Sequence Number: 1
• Product Code: DRA
• Combination Product (y/n): N
• Reporter Country Code: IT
• PMA/PMN Number: K081049
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,l
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 09/17/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/17/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 3FC12
• Device Catalogue Number: 3FC12
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 09/09/2019
• 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): Hospitalization; Life Threatening; Required Intervention
• Patient Age: 60 YR