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

Model Number D-1183-08-S

Device Problems Power Conditioning Problem (1474); Device Operates Differently Than Expected (2913); Temperature Problem (3022)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 07/11/2016

Event Type  malfunction  

Manufacturer Narrative

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.(b)(4).

Event Description

It was reported that a patient underwent an atrioventricular nodal reentry tachycardia procedure with a navistar electrophysiology catheter and a coagulum formation occurred on the catheter tip.The catheter was replaced and the case resumed.There were no errors present on bwi systems during the procedure.The physician saw high temperature with very low power.A non-irrigated catheter was used during the procedure; however heparin was administered to patient by the physician.The generator was in power control mode, power was between 15-20 watts with a cut off of 55watts, temperature cutoff 65 degrees c.The procedure was completed with no patient consequence.The patient has not exhibited any neurological symptoms since the procedure was completed.This event has been assessed as mdr reportable since coagulum has poor adherence to catheters, it could be a potential source of embolism and a risk to the patient.

Manufacturer Narrative

(b)(4).It was reported that a patient underwent an atrioventricular nodal reentry tachycardia procedure with a navistar electrophysiology catheter and a coagulum formation occurred on the catheter tip.The physician saw high temperature with very low power.The returned device was visually inspected upon receipt 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.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 customer complaint regarding a coagulum and high temperature cannot be confirmed.Char was found at catheter tip.The catheter passed all tests.The root cause does not appear to be manufactured related.

• 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 ; 33 technology drive; irvine, CA 92618 ; 9497893837
• MDR Report Key: 5845334
• MDR Text Key: 52415850
• Report Number: 9673241-2016-00469
• Device Sequence Number: 1
• Product Code: DRF
• UDI-Device Identifier: 10846835000610
• UDI-Public: (01)10846835000610(11)151026(17)180930(10)17335290M
• 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,Followup
• Report Date: 07/14/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/03/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 09/30/2018
• Device Model Number: D-1183-08-S
• Device Catalogue Number: NS7TCFL174HS
• Device Lot Number: 17335290M
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/27/2016
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 07/11/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/26/2015
• 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