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

Model Number D-1183-08-S

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Pain (1994); Tachycardia (2095); Pericardial Effusion (3271)

Event Date 06/30/2015

Event Type  Injury  

Event Description

It was reported that a patient underwent an idiopathic ventricular tachycardia - right (r-idvt) procedure with a navistar catheter and suffered a pericardial effusion.The patient¿s medical history is unknown.During the mapping phase, the patient was experiencing pain.A transthorasic echo was performed and a small pericardial effusion was observed.Herparin was reversed and the patient was transferred to the critical care unit for observation.There is no further information about the hospitalization and if any intervention was performed.No information is known regarding the patient status.The physician did not provide a causality opinion for the cause of this adverse event.Multiple attempts have been made to obtain clarification to this complaint.However, no further information has been made available.

Manufacturer Narrative

If additional information is received regarding this event, a supplemental 3500a report will be submitted to the fda.The bwi failure analysis lab received the device for evaluation.The analysis has begun but is not completed at this time.When the investigational analysis has been completed, a supplemental 3500a report will be submitted.The device history record (dhr) was reviewed.The dhr review verifies that the device was manufactured in accordance with documented specification and procedures.(b)(4).Concomitant products: carto 3 system, model #:m-4800-01, serial #: (b)(4), 2.Stockert 70 system, model #: m-5463-01, serial #: (b)(4), 3.Pentaray nav eco catheter, model #: d-1282-11-s.Lot#: 17234938l (b)(4).

Manufacturer Narrative

(b)(4) it was reported that a patient underwent an idiopathic ventricular tachycardia - right (r-idvt) procedure with a navistar catheter and suffered a pericardial effusion.During the mapping phase, the patient was experiencing pain.A transthoracic echo was performed and a small pericardial effusion was observed.Heparin was reversed and the patient was transferred to the critical care unit for observation.Upon receipt, the catheter was visually inspected and it was found in normal conditions.Per the event, the catheter was tested for electrical performance, temperature response and stockert compatibility and it was found within specifications.Furthermore, an irrigation test was performed and the catheter passed, no occlusion was observed.A deflection test was performed and the catheter passed.The catheter failed during biosensor functionality test and carto.Error 105 was displayed.Further examination showed that the sensor was within specifications.According to the calibration results and the sensor readings, the improper condition was attributed to a potential pc board failure.An internal corrective action has been opened to investigate the potential pcb issues/intermittency.The device history record (dhr) was reviewed and no anomalies were found related to this complaint.In addition, the dhr review verifies that the device was manufactured in accordance with documented specification and procedures.The catheter passed all specifications.The catheter failed the carto test however it is not related to the pericardial effusion and the root cause of it remains unknown.The ifu states that careful catheter manipulation must be performed in order to avoid cardiac damage, perforation or tamponade.An internal corrective action has been opened to investigate the potential pcb issues/intermittency.

• 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: shahe garabedian ; 9098397362
• MDR Report Key: 4922712
• MDR Text Key: 6015664
• Report Number: 9673241-2015-00460
• 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,company representative
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 06/30/2015

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: 12/31/2017
• Device Model Number: D-1183-08-S
• Device Catalogue Number: NS7TCFL174HS
• Device Lot Number: 17170303M
• Other Device ID Number: (01)10846835000610
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/15/2015
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 06/30/2015
• Initial Date FDA Received: 07/17/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/25/2015
• 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): Other