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

Model Number	4FC12
Health Effect - Clinical Codes	Dyspnea (1816); Low Blood Pressure/ Hypotension (1914); Tachycardia (2095); Pericardial Effusion (3271)
Date of Event	04/03/2018
Type of Reportable Event	Serious Injury
Additional 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 or Problem 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.
Additional Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.

• Brand Name: FLEXCATH ADVANCE STEERABLE SHEATH
• Common Device Name: CATHETER, STEERABLE
• Manufacturer (Section D): MEDTRONIC CRYOCATH LP; 9000 autoroute transcanadienne; pointe-claire,qc H9R 5 Z8; CA H9R 5Z8
• MDR Report Key: 7754323
• Report Number: 3002648230-2018-00536
• Device Sequence Number: 13724441
• Product Code: DRA
• UDI-Device Identifier: 00643169688872
• UDI-Public: 00643169688872
• Combination Product (Y/N): N
• Initial Reporter State: IA
• Initial Reporter Country: US
• PMA/510(K) Number: K123591
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 10/04/2018

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
• Operator of Device: 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
• Initial Date Received by Manufacturer: 07/11/2018
• Supplement Date Received by Manufacturer: 08/08/2018
• Initial Report FDA Received Date: 08/06/2018
• Supplement Report FDA Received Date: 10/03/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Weight: 54