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

Model Number 4FC12

Device Problems Adverse Event Without Identified Device or Use Problem (2993); Appropriate Term/Code Not Available (3191)

Patient Problem Pericardial Effusion (3271)

Event Date 06/20/2018

Event Type  Injury  

Manufacturer Narrative

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

Event Description

It was reported that during a cryo ablation procedure, pericardial effusion was diagnosed.The balloon catheter was removed from the patient's body and a pericardiocentesis was performed, in which a significant amount of blood was aspirated.The case was aborted and the patient was under general anesthesia.No further patient complications have been reported as a result of this event.

Manufacturer Narrative

Event summary: the patient data file showed at least five applications were performed with catheter 2af284 /06097 on the date of the event.System notice (#50003) was received indicating that the pressure was low in the system triggered on the first application.A clinical issue was encountered during the procedure, and pericardial effusion was diagnosed.The balloon catheter was removed from the patient's body and a pericardiocentesis was performed, in which a significant amount of blood was aspirated.The case was aborted, and the patient was under general anesthesia.The sheath ,4fc12/48523, was not returned for investigation.In conclusion, clinical issue (pericardial effusion) was encountered during procedure.There is no indication of product malfunction related to the adverse event.The sheath was not returned for investigation.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: 7663926
• MDR Text Key: 113205024
• Report Number: 3002648230-2018-00465
• Device Sequence Number: 1
• Product Code: DRA
• UDI-Device Identifier: 00763000043773
• UDI-Public: 00763000043773
• 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: 08/23/2018

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
• Device Operator: Health Professional
• Device Expiration Date: 03/27/2020
• Device Model Number: 4FC12
• Device Catalogue Number: 4FC12
• Device Lot Number: 48523
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 06/20/2018
• Initial Date FDA Received: 07/05/2018
• Supplement Dates Manufacturer Received: 07/27/2018
• Supplement Dates FDA Received: 08/23/2018
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 03/29/2018
• 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
• Treatment: 2AF284- BALLOON CATHETER
• Patient Outcome(s): Required Intervention
• Patient Age: 62 YR