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

Model Number 4FC12

Device Problem Insufficient Information (3190)

Patient Problems Hemorrhage/Bleeding (1888); Low Blood Pressure/ Hypotension (1914); Cardiac Tamponade (2226)

Event Date 10/21/2014

Event Type  Injury  

Event Description

Medtronic received information of a cardiac tamponade that occurred during a cryoablation procedure.Approximately 10 minutes post transseptal puncture, there was a drop in the patient's blood pressure.Observation of heart shadow showed tamponade.The physician punctured and tried to drain blood with autolog retransfusion for about half an hour.Protamine administered and patient's act dropped from 300 to 230.Patient's blood pressure stabilized (at about 140/80) and the hospital team transported the patient to surgery.During transportation, patient's blood pressure dropped again.It was necessary to open the patient's thorax six times in order to calm the bleeding and to perform several processes.Patient is on extracorporeal membrane oxygenation (ecmo) and remains in critical condition.Physician believes that the tamponade occurred during transseptal puncture.

Event Description

Medtronic received information of a cardiac tamponade that occurred during a cryoablation procedure.Approximately 10 minutes post transseptal puncture, there was a drop in the patient's blood pressure.Observation of heart shadow showed tamponade.The physician punctured and tried to drain blood with autolog retransfusion for about half an hour.Protamine administered and patient's act dropped from 300 to 230.Patient's blood pressure stabilized (at about 140/80) and the hospital team transported the patient to surgery.During transportation, patient's blood pressure dropped again.It was necessary to open the patient's thorax six times in order to calm the bleeding and to perform several processes.Patient is on extracorporeal membrane oxygenation (ecmo) and remains in critical condition.Physician believes that the tamponade occurred during transseptal puncture.Update received (b)(4) 2014 indicated that the patient is recovering.Patient remains hospitalized and is showing slight problems with speech.

Manufacturer Narrative

The device has not yet been returned for evaluation.Results of evaluation of returned device will be submitted in a supplemental report.

Manufacturer Narrative

The returned device was visually and functionally tested and passed the inspection as per specification.

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; 16771 chemin ste-marie; kirkland,qc H9H 5 H3; CA H9H 5H3
• Manufacturer (Section G): MEDTRONIC CRYOCATH LP; 16771 chemin ste-marie; kirkland,qc H9H 5 H3; CA H9H 5H3
• Manufacturer Contact: voula radiotis ; 16771 chemin ste-marie; kirkland,qc H9H 5-H3 ; CA H9H 5H3 ; 5146941212
• MDR Report Key: 4245340
• MDR Text Key: 5108124
• Report Number: 3002648230-2014-00197
• Device Sequence Number: 1
• Product Code: DRA
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: K123591
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative,company representati
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 10/21/2014

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
• Device Operator: Health Professional
• Device Expiration Date: 07/01/2016
• Device Model Number: 4FC12
• Device Catalogue Number: 4FC12
• Device Lot Number: 03818
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/13/2014
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 12/30/2014
• Initial Date FDA Received: 11/12/2014
• Supplement Dates Manufacturer Received: Not provided; Not provided; 12/30/2014
• Supplement Dates FDA Received: 12/09/2014; 01/07/2015; 09/15/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/01/2014
• 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: 00062 YR
• Patient Weight: 75