MAUDE Adverse Event Report: BIOSENSE WEBSTER, INC. (JUAREZ) NAVISTAR¿ ELECTROPHYSIOLOGY CATHETER; CATHETER, ELECTRODE RECORDING

Model Number D-1183-07-S

Device Problem Device Displays Incorrect Message (2591)

Patient Problems Cardiac Tamponade (2226); Cardiac Perforation (2513); Pericardial Effusion (3271)

Event Date 02/24/2016

Event Type  Injury  

Manufacturer Narrative

The product was discarded, therefore no product failure analysis can be conducted and device malfunction cannot be confirmed.The device history record (dhr) has been reviewed and it was verified that device was manufactured in accordance with documented specifications and procedures.(b)(4).Concomitant product: stockert 70 system, model #: m-5463-01, serial #: unknown.No testing methods performed.No results available since no evaluation performed.Device discarded by user, unable to follow-up.(b)(4).

Event Description

It was reported that a (b)(6) year old male patient underwent an idiopathic ventricular tachycardia - right (r-idvt) procedure with a navistar catheter and suffered a cardiac tamponade which required a pericardiocentesis, cpr and surgical intervention.The patient's medical history was unknown.The patient suffered a cardiac perforation and subsequent pericardial effusion which was discovered at the end of a right ventricular outflow tract ablation.Anesthesia vitals monitoring indicated a hemodynamic change post procedure.The anesthesiologist notified the physician that the patient was decompensating.A transthoracic echo confirmed the pericardial effusion.They performed a pericardiocentesis in the ep lab.The patient was then transported to the operating room for surgical intervention.The patient was reported to be in an improved condition.The patient required 5 days of hospitalization for post recovery.There is no information about the hospitalization.There was no transseptal puncture performed.There was no catheter error alerts indicated from the carto 3 system.There was no catheter visualization issues observed on either the lab or control room monitor.The ablation catheter impedance, tip temperature, time setting, watts and target temp readings displayed on stockert generator.The last ablation cycle time at the site of injury was 43 seconds.The generator was set to temperature control mode at 50 watts/60 degree celsius.They noted the temperature of 57 degree celsius, impedance of 120ohm and power of 49 watts at the time of injury.The power titration during ablation did not occur at every ablation application.It was not known if there was any anticoagulation given to the patient in the procedure.There was no physical damage or catheter functionality issues communicated by the physician.The physician did not provide a causality opinion for the cause of this adverse event.

• Brand Name: NAVISTAR¿ ELECTROPHYSIOLOGY CATHETER
• Type of Device: CATHETER, ELECTRODE RECORDING
• Manufacturer (Section D): BIOSENSE WEBSTER, INC. (JUAREZ); circuito interior norte #1820; parque industrial salvacar; juarez, chihuahua 32599 ; MX 32599
• Manufacturer (Section G): BIOSENSE WEBSTER, INC. (JUAREZ); circuito interior norte #1820; parque industrial salvacar; juarez, chihuahua 32599 ; MX 32599
• Manufacturer Contact: joaquin kurz ; 9497893837
• MDR Report Key: 5504927
• MDR Text Key: 40540046
• Report Number: 9673241-2016-00201
• Device Sequence Number: 1
• Product Code: DRF
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P990025
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 02/24/2016

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: 07/31/2017
• Device Model Number: D-1183-07-S
• Device Catalogue Number: NS7TCDL174HS
• Device Lot Number: 17063735M
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 02/24/2016
• Initial Date FDA Received: 03/16/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/01/2014
• 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: 56 YR