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

Model Number 4FC12

Device Problem Insufficient Information (3190)

Patient Problems Cardiac Arrest (1762); Cardiac Arrest (1762); Death (1802); Blood Loss (2597); Blood Loss (2597); Pericardial Effusion (3271)

Event Date 07/11/2015

Event Type  Death  

Manufacturer Narrative

The information submitted reflects all relevant data received.If additional relevant information is received, a supplemental report will be submitted.The device is not available for analysis as it was discarded by the user facility; however, investigation is in progress.Results of investigation will be submitted in a supplemental report.(b)(4).

Event Description

It was reported that post cryo ablation procedure the patient's blood pressure steadily decreased.An echocardiogram was performed which revealed a pericardial effusion.A pericardiocentesis was performed and seven hundred milliliters of blood were removed during the procedure.During the pericardiocentesis procedure the patient went into cardiac arrest and cardiopulmonary resuscitation (cpr) was performed.The patient was transferred to the operating room (or) and a cardiothoracic surgeon performed an open chest procedure.It was reported that the pericardiocentesis drain was in an appropriate position.A large amount of blood was found in the abdomen and the source was not determined.The patient expired two days later.

Manufacturer Narrative

Product event summary: neither bin files nor product has been returned for analysis; no indication of product malfunction.

Event Description

Additional information received from the physician whom performed the procedure.This information indicates that the physician was unsure of the labiality of the blood pressure but was not contacted until the systolic blood pressure was low in the sixties, the physician was unsure of the exact amount of blood removed from the pericardial drain but was several hundred cc's.The cardiothoracic surgeon did find blood in the chest which was still in the pericardial space but no perforation was found.The blood noted in the abdomen was observed by the nurse in the cardiac care unit after the thoracic surgery and was coming from the gastric tube; the thoracic surgeon never opened the abdomen.To the physician's knowledge, no autopsy was done.

• Brand Name: FLEXCATH ADVANCE STEERABLE SHEATH
• Type of Device: CATHETER, STEERABLE
• Manufacturer (Section D): MEDTRONIC CRYOCATH LP; 16771 chemin ste-marie; kirkland H9H 5 H3; CA H9H 5H3
• Manufacturer (Section G): MEDTRONIC CARDIAC RHYTHM HEART FAILURE; 8200 coral sea st ne; mounds view MN 55112
• Manufacturer Contact: anne schilling ; 8200 coral sea st ne; mounds view, MN 55112 ; 7635052036
• MDR Report Key: 4991525
• MDR Text Key: 22535062
• Report Number: 3002648230-2015-00228
• 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: company representative,health
• Reporter Occupation: Physician
• Report Date: 07/13/2015

1 Device was Involved in the Event

2 Patient was Involved in the Event

• Date FDA Received: 08/11/2015
• 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: 08/17/2015
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 0
• Patient Outcome(s): Death; Hospitalization; Life Threatening; Required Intervention