MAUDE Adverse Event Report: MEDTRONIC CRYOCATH LP ACHIEVE MAPPING CATHETER - 15 MM; CATHETER, ELECTRODE RECORDING, OR PROBE, ELECTRODE RECORDING

Model Number 990063-015

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 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.Of note, multiple patients were noted in the article; however, a one to one correlation could not be made with unique product serial/lot numbers.The overall baseline gender characteristics is male; the age of the patients was 58 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.A request for additional information will be made and upon receipt a supplemental report will be submitted accordingly.Referenced article: ¿anatomical and procedural factors of severe pulmonary vein stenosis after cryoballoon pulmonary vein ablation.¿ jacc clin electrophysiol.2019 nov;5(11):1303-1315.Doi: 10.1016/j.Jacep.2019.08.003.Epub 2019 oct 30.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 patients with transient phrenic nerve palsy (pnp).There were patients with ¿severe¿ pulmonary vein (pv) stenosis; during the followup period, the patients underwent a computerized tomography (ct) scan.One of these patients underwent a balloon angioplasty due to the progression of the pv stenosis.There was one patient who required vascular surgery due to an arteriovenous fistula on the seventh day post-operative.The following complication did not require any treatment: ¿mild/moderate¿ pulmonary vein stenosis.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: ACHIEVE MAPPING CATHETER - 15 MM
• Type of Device: CATHETER, ELECTRODE RECORDING, OR PROBE, ELECTRODE RECORDING
• 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: 9519628
• MDR Text Key: 185935440
• Report Number: 3002648230-2019-00857
• Device Sequence Number: 1
• Product Code: DRF
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K102588
• 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: 12/26/2019

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: Health Professional
• Device Model Number: 990063-015
• Device Catalogue Number: 990063-015
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 11/27/2019
• Initial Date FDA Received: 12/26/2019
• 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: 58 YR