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 Problems Fistula (1862); Hematoma (1884); Pericardial Effusion (3271)

Event Date 01/01/2018

Event Type  Injury  

Manufacturer Narrative

Concomitant medical products: 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 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/61 years old.Of note, multiple patients were noted in the article; however, a one to one correlation could not be made with unique product lot/serial numbers.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: plaaf score as a novel predictor of long-term outcome after second-generation cryoballoon pulmonary vein isolation.Europace.2018 nov 1;20(fi_3): f436-f443.Doi: 10.1093/europac e/eux295.If information is provided in the future, a supplemental report will be issued.

Event Description

The literature publication reported the following patient complications during the use of a cryoballoon ablation catheter system: there were 16 patients who experienced phrenic nerve palsy (pnp); all of which recovered within six months of the procedure.There were eight patients who had vascular complications (one (1) major hematoma repaired surgically, five (5) minor groin hematomas, and two (2) arteriovenous fistulas without intervention.There was one (1) patient had a transient air embolism resulting in transient st-segment elevation and chest pain for several seconds.According to the article, ¿during the post-pvi hospital stay, cardiac magnetic resonance imaging with adenosine stress detected no ischaemia or new scar formation.¿ there were also two (2) patients who developed pericardial effusion, not requiring drainage.Another patient exhibited hemiplegia the day after the procedure, with no further complication and complete resolution within three hours.Of note, multiple patients were noted in the article; however, a one to one correlation could not be made with unique product lot numbers.The status/disposition of the cryoablation catheter system 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 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: paula bixby ; 8200 coral sea st ne; mounds view, MN 55112 ; 7635055378
• MDR Report Key: 9225136
• MDR Text Key: 163905700
• Report Number: 3002648230-2019-00724
• Device Sequence Number: 1
• Product Code: DRA
• Combination Product (y/n): N
• Reporter Country Code: GM
• 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: 10/23/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/23/2019
• 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: 09/26/2019
• 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: 61 YR