MAUDE Adverse Event Report: ST. JUDE MEDICAL, COSTA RICA LTDA INQUIRY TM STEERABLE DIAGNOSTIC CATHETER 1110-4-25-M CATHETER; ELECTRODE RECORDING CATHETER

Model Number 81531

Device Problems Bent (1059); Electrical /Electronic Property Problem (1198)

Patient Problem Cardiac Perforation (2513)

Event Date 03/13/2015

Event Type  Injury  

Event Description

Related manufacturer reference number 3005188751-2015-00031, 3005188751-2015-00032, 2030404-2015-00029, 3005188751-2015-00033, 3005188751-2015-00034, 2030404-2015-00030.During a pulmonary vein isolation ablation procedure, a pericardial effusion occurred.An inquiry ep catheter was inserted into the cs and distortion of the signal and shape was noted on velocity.Fluoroscopy revealed a bend in the catheter at the proximal electrode.The catheter was replaced with another inquiry ep catheter and the case continued.Transseptal puncture was performed x 2, and geometry with voltage mapping was completed.Cryo-ablation was performed to all pulmonary veins.The patient was then hypotensive.Intracardiac echo, fluoroscopy and an echocardiogram revealed a pericardial effusion.A pericardiocentesis was performed which stabilized the patient.

Manufacturer Narrative

(b)(4).One decapolar, 4f, inquiry steerable diagnostic catheter (1110-4-25-m) was received for evaluation.A kink in the shaft was noted at 2.10¿ proximal to the distal tip.Functional and electrical testing met device specifications.The device met specifications prior to release from sjm manufacturing facilities as supported by the device history record.The cause of the kinked shaft is consistent with damage during use.The cause of the reported pericardial effusion remains unknown as the event could not be confirmed.Per the ifu, vascular perforation in an inherent risk of any electrode placement.

• Brand Name: INQUIRY TM STEERABLE DIAGNOSTIC CATHETER 1110-4-25-M CATHETER
• Type of Device: ELECTRODE RECORDING CATHETER
• Manufacturer (Section D): ST. JUDE MEDICAL, COSTA RICA LTDA; parque industrial, zona franca coyol s.a.; edificio #44b, calle 0, avenida 2, coyol; alajuela 1897- 4050; CS 1897-4050
• Manufacturer (Section G): ST. JUDE MEDICAL, COSTA RICA LTDA; parque industrial, zona franca coyol s.a.; edificio #44b, calle 0, avenida 2, coyol; alajuela 1897 -405; CS 1897-4050
• Manufacturer Contact: denise johnson ; 5050 nathan lane north; plymouth, MN 55442 ; 6517564470
• MDR Report Key: 4680630
• MDR Text Key: 21174054
• Report Number: 3008452825-2015-00019
• Device Sequence Number: 1
• Product Code: DRF
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K961924
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 03/13/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/10/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 10/31/2017
• Device Model Number: 81531
• Device Lot Number: 4886621
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/30/2015
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/13/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/20/2014
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: INQUIRY STEERABLE DIAGNOSTIC CATHETER; SUPREME ELECTROPHYSIOLOGY CATHETER X 2; AGILIS NXT STEERABLE INTRODUCER; INQUIRY OPTIMA DIAGNOSTIC CATHETER; BRK-1 TRANSSEPTAL NEEDLE
• Patient Outcome(s): Required Intervention
• Patient Age: 75 YR
• Patient Weight: 68