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 Dyspnea (1816); Low Blood Pressure/ Hypotension (1914); Tachycardia (2095); Pericardial Effusion (3271)

Event Date 04/03/2018

Event Type  Injury  

Manufacturer Narrative

Event summary: clinical issues were encountered during a cryo ablation procedure, the patient experienced cough and shortness of breath.An echo was performed and showed minimal anterior and posterior pericardial effusion.Additionally, the patient experienced a drop in blood pressure and became tachycardiac.The case was aborted while the patient was under general anesthesia.Echo revealed that the patient had a significant effusion.The sheath, 4fc12/31705, was not returned for investigation.In conclusion, clinical issues (cough, shortness of breath, pericardial effusion and hypotension and tachycardiac) were encountered during procedure.There is no indication of catheter malfunction related to the adverse event.The sheath was not returned for investigation.The case was aborted while the patient was under general anesthesia.If information is provided in the future, a supplemental report will be issued.

Event Description

It was reported that during a cryo ablation procedure, the patient experienced cough and shortness of breath.An echo was performed and showed minimal anterior and posterior pericardial effusion.Additionally, the patient experienced a drop in blood pressure and became tachycardiac.The case was aborted while the patient was under general anesthesia.Echo revealed that the patient had a significant effusion.Medication was given and a pericardiocentesis was performed.Ultimately, the effusion resolved with only a minimal effusion and the patient was hemodynamically stable at discharge from the lab.This patient was part of the stop af first clinical study.No further patient complications have been reported as a result of this event.

Manufacturer Narrative

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

• 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: 7754323
• MDR Text Key: 116206594
• Report Number: 3002648230-2018-00536
• Device Sequence Number: 1
• Product Code: DRA
• UDI-Device Identifier: 00643169688872
• UDI-Public: 00643169688872
• 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: company representative,health
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 10/04/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/06/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 01/05/2020
• Device Model Number: 4FC12
• Device Catalogue Number: 4FC12
• Device Lot Number: 31705
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/08/2018
• Date Device Manufactured: 01/05/2018
• 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
• Patient Outcome(s): Required Intervention
• Patient Weight: 54