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

Model Number 4FC12

Device Problem Air Leak (1008)

Patient Problems Air Embolism (1697); Low Blood Pressure/ Hypotension (1914); ST Segment Elevation (2059); Low Cardiac Output (2501); Atrial Perforation (2511); Pericardial Effusion (3271)

Event Date 11/14/2016

Event Type  Injury  

Event Description

It was reported that during a cryoablation procedure, the patient experienced st elevation.Five minutes later, st elevation depressed.It was further reported that the right coronary artery was slightly spastic.Iv medication was administered and the case was continued.The patient¿s blood pressure fell, hypokinesia was noted during treatment, and an echocardiogram revealed anomalous pericardial effusion.Pericardiocentesis was performed.The physician was suspicious of perforation of the left atrium.After the procedure, fluoroscopic images were reviewed and slight aeration was found at the time of the occlusion.The case was completed with cryo.No further patient complications have been reported as a result of this event.

Manufacturer Narrative

Product event summary: the sheath was not returned for investigation.Bin files were analyzed on 21 december, 2016.The reported issues of st levels increasing, a spastic right coronary artery, and possible perforation of the left atrium cannot be confirmed through data analysis.This is a clinical issue encountered during the procedure(st elevation); there is no product malfunction reported.

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, quebec H9H 5 H3; CA H9H 5H3
• Manufacturer (Section G): MEDTRONIC CRYOCATH LP; 9000 autoroute transcanadienne; pointe-claire, quebec H9H 5 H3; CA H9H 5H3
• Manufacturer Contact: anne schilling ; 8200 coral sea st ne; mounds view, MN 55112 ; 7635052036
• MDR Report Key: 6153653
• MDR Text Key: 61694853
• Report Number: 3002648230-2016-00512
• Device Sequence Number: 1
• Product Code: DRA
• UDI-Device Identifier: 00643169688872
• UDI-Public: 00643169688872
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K123591
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 11/14/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/07/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 4FC12
• Device Catalogue Number: 4FC12
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/21/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/20/2016
• 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: 239F5 ELECTROPHYSIOLOGY CATHETER
• Patient Outcome(s): Hospitalization; Life Threatening; Required Intervention