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

Model Number 990065

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

Patient Problems Chest Pain (1776); Non specific EKG/ECG Changes (1817); Low Blood Pressure/ Hypotension (1914); Tachycardia (2095); Pericardial Effusion (3271); Heart Block (4444)

Event Date 08/31/2021

Event Type  Injury  

Manufacturer Narrative

If information is provided in the future, a supplemental report will be issued.

Event Description

It was reported that after a successful pulsed field ablation procedure, the patient became hypotensive and a pericardial effusion was diagnosed via intracardiac echocardiography (ice).Additional diagnostic tests were performed and st elevation with sinus tachycardia and a first degree heart block were noted on the electrocardiogram (ecg).A pericardiocentesis was performed to treat the effusion.Pain medication was administered due to the patient experiencing chest pain.The patient hospitalization stay was extended.The patient is a participant in a clinical study.No further patient complications have been reported as a result of this event.

• Brand Name: FLEXCATH SELECT STEERABLE SHEATH
• Type of Device: INTRODUCER, CATHETER
• 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: 12634937
• MDR Text Key: 276472019
• Report Number: 3002648230-2021-00468
• Device Sequence Number: 1
• Product Code: DYB
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K142684
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 10/14/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/14/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 06/07/2023
• Device Model Number: 990065
• Device Catalogue Number: 990065
• Device Lot Number: 0010691254
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/30/2021
• Date Device Manufactured: 06/07/2021
• 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: 59 YR
• Patient Weight: 132