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); Cardiac Tamponade (2226); Cardiac Perforation (2513); Pericardial Effusion (3271); Embolism/Embolus (4438)

Event Date 05/01/2021

Event Type  Injury  

Manufacturer Narrative

This information is based entirely on journal literature. Medtronic was made aware of this event through a search of literature publications. This event occurred outside the us. Patient information is limited due to confidentiality concerns. Of note, multiple patients and multiple manufacturers were noted in the article; however, a one to one correlation could not be made with unique product serial/lot numbers. The baseline gender/age characteristics is male/(b)(6). 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: real-world safety profile of atrial fibrillation ablation using a second-generation cryoballoon in japan insight from a large multicenter observational study. Journal of the american college of cardiology:clinical electrophysiology. 2021. 7:60413. Doi. Org/10. 1016/j. Jacep. 2020. 11. 016 if information is provided in the future, a supplemental report will be issued.

Event Description

A journal article was reviewed that contained information regarding cryoballoon ablation. The article reports patients who experienced air embolisms which manifested as a transient st-segment elevation in the inferior leads and one patient experienced subsequent ventricular fibrillation (vf) requiring electrical cardioversion. There were patients that had cardiac tamponade which required pericardiocentesis, among them, some patients with perforations occurred by a transseptal puncture and cavotricuspid isthmus ablation which required emergent surgery, symptomatic gastric hypomotility (abdominal bloating and repeated vomiting) requiring readmission or prolongation of the admission, all patients with gastric issues recovered after fasting and medical treatment. There were three cases of strokes, one with an epileptic seizure and impairment of consciousness during the procedure who recovered under medical treatment including an antiepileptic drug, another stroke with impairment of consciousness which continued post-procedure, and a third stroke hemiplegia appeared the day after the procedure despite uninterrupted warfarin therapy. All patients with strokes recovered without any neurological sequelae after conservative treatment. Three other patients experienced transient ischemic attack (tia) and were bridged with heparin. There were two patients experienced brainstem hemorrhages and cerebellar hemorrhages at four days and one month post-procedure while taking direct oral anticoagulants, respectively. Both patients recovered under conservative treatment. Other patients developed coronary spasms, and all recovered spontaneously or after an intravenous/intracoronary nitroglycerin adm inistration. Four patients experienced pericarditis (clinically significant manifestations requiring medication) post-procedure, and all recovered with medical treatment including anti-inflammatory drugs. Femoral arteriovenous fistulae, pseudoaneurysms, deep vein thromboses, and pneumothoraxes occurred in other patients. Two patients with arteriovenous fistulae required surgery. The pseudoaneurysms disappeared with direct compression in five patients, while the remaining three required surgery. One patient experienced sepsis post-procedure and recovered with conservative treatment. The status/disposition of the catheters and sheaths is unknown. No further patient complications have been reported as a result of this event. Further follow up did not yet yield any additional information.

• 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: 12425421
• MDR Text Key: 270663932
• Report Number: 3002648230-2021-00417
• Device Sequence Number: 1
• Product Code: DRA
• Combination Product (y/n): N
• Reporter Country Code: US
• 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: Other Health Care Professional
• Type of Report: Initial
• Report Date: 09/03/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/03/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No

Device Operator

• Device Model Number: 4FC12
• Device Catalogue Number: 4FC12
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes

Was the Report Sent to FDA?

• Event Location: No Information
• Date Manufacturer Received: 08/16/2021
• Was Device Evaluated by Manufacturer?: No Answer Provided
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial

Patient Treatment Data

Date Received: 09/03/2021 Patient Sequence Number: 1