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 Death (1802); Hemoptysis (1887); Pneumonia (2011); Respiratory Failure (2484)

Event Date 01/01/2018

Event Type  Death  

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 us.All information provided is included in this report.Patient information is limited due to confidentiality concerns.The date of death is not available at the time of this report; as there is no indication of specific lot number/patient information.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 baseline gender/age characteristics is male/75 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: ¿efficacy and safety of cryoballoon ablation in the elderly: a multicenter study.¿ int j cardiol (2018), https://doi.Org/10.1016/j.Ijcard.2018.09.090.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 system: there were two (2) patients who developed cardiac tamponade; which required drainage.There were also eight (8) patients who had phrenic nervepalsy (pnp); all of which resolved within 12 months.There were eight (8) patients who had groin-site complications (bleeding); which required transfusions and/or ¿conservative¿ treatment.There was one (1) patient who experienced a stroke/transient ischemic attack (tia); who recovered without sequelae.There was one (1) patient who experienced pericardial effusion, but no treatment was required.There was one (1) patient who experienced a myocardial infarction/air embolism/st elevation with no effects.There was one (1) patient death.This patient, according to the author, ¿experienced periprocedural haemoptysis, developed pneumonia and died due to nosocomial pneumonia and respiratory failure 13 days following intensive care treatment after ablation.¿ of note, multiple patients we re noted in the article; however, a one to one correlation could not be made with unique product lot numbers.The status/location of the cryoablation 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: anne schilling ; 8200 coral sea st ne; mounds view, MN 55112 ; 7635052036
• MDR Report Key: 8064037
• MDR Text Key: 126918876
• Report Number: 3002648230-2018-00825
• 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: 11/13/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/13/2018
• 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: 10/15/2018
• 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
• Treatment: ACHIEVE MAPPING CATHETER
• Patient Outcome(s): Death; Hospitalization; Required Intervention
• Patient Age: 75 YR