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

Model Number D-1285-02-S

Device Problems Device Displays Incorrect Message (2591); Device Contamination with Chemical or Other Material (2944)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 01/27/2016

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.If additional information is received regarding this event, a supplemental 3500a report will be submitted to the fda.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).Event description continuation: the following lab findings were assessed as reportable malfunctions.Internal components were exposed.Therefore, the catheter integrity was not maintained and may expose the patient to a risk for thrombus formation.The electrode ring edges appearing to be sharp or rough with the pu margins peeling on both sides as they may cause damage to vascular endothelial linings during the withdrawal of the catheter and sheath.Also the foreign material was within the usable length of the catheter.The awareness date for the biosense webster failure analysis findings were february 24, 2016.

Event Description

It was reported that a patient underwent an atrial fibrillation (afib) procedure with a c3 coronary sinus refstar - deflectable catheter.It was initially reported that there was a catheter sensor error 116 displayed on the carto 3 system.The catheter cable was replaced and the issue remained.The catheter was replaced and the issue resolved.The procedure was completed with no patient consequence.The incidence of magnetic sensor error was easy detectable by the user.The catheter was inoperable , since it could not be visualized on the carto system.The user will have to replace the catheter.The most likely consequence was an intraprocedural delay.The potential risk that it could cause or contribute to a serious injury or death was remote.Therefore, this issue was assessed as not reportable.The product was received for analysis in the biosense webster failure analysis lab and it was discovered on february 24, 2016 that the tip lumen was bent and torn open with internal parts exposed about 7.8cm and with white stress marks about 8.7cm from the distal tip dome.The shaft and tip lumen had off-white sticky foreign material with fibers on it.Ring # 1 was dented, damaged and sharp on the proximal side.The polyurethane (pu) margins were peeling on both sides.The tip lumen had stress on both sides of ring #1.Ring #3 had the proximal side damaged and sharp with a white stress mark on the tip lumen material.It had light yellowish foreign material on the rings and tip lumen.Multiple attempts have been made to obtain clarification to the returned catheter condition.However, no further information has been made available.

Manufacturer Narrative

(b)(4).It was reported that a patient underwent an atrial fibrillation (afib) procedure with a c3 coronary sinus refstar ¿ deflectable catheter.It was initially reported that there was a catheter sensor error 116 displayed on the carto 3 system.The catheter cable was replaced and the issue remained.The catheter was replaced and the issue resolved.The procedure was completed with no patient consequence.Upon receipt, the catheter was visually inspected and the tip lumen was found bent and torn open with internal parts exposed with a type of off-white sticky foreign material with fibers on it.Due to the exposed parts, an electrical test was performed and catheter passed.Therefore, we can conclude all the electrical wires were perfectly insulated.A fourier transform infrared spectroscopy (ft-ir) was performed to the foreign material found on the device and results demonstrated that acrylate was the base component of the material.The sticky condition confirms the origin since adhesive is one of the principal applications of this material.Continuing with the visual inspections catheter electrodes were found damaged and with stress marks.The catheter outer diameters were measured and it was found within specifications.All the conditions found on the catheter were not reported on the original complaint.Clarifications were requested to the customer; however this information has not been available for bwi.During manufacturing process all the catheters are inspected for visual damages before packaging.On line inspections are in place to prevent this type of damage/defect from leaving the facility.The catheter was then evaluated for eeprom, and the functionality of the sensor catheter was tested on carto system.Eeprom data demonstrates the catheter was properly calibrated during manufacturing.The catheter was recognized by carto 3 system, however error 116 was displayed.The catheter was then dissected and it was determined that the root cause was an internal failure of the sensor.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 sensor error has been verified.Based on available analysis results, the complaint appears to be caused by internal biosense webster inc.Processes.Regarding the physical conditions observed on the catheter, based on the available analysis finding results, the root cause does not appear to be due to any internal biosense webster inc.Since all catheters are inspected for visual damages before packaging to avoid this kind of failures.

• Brand Name: DECANAV¿ ELECTROPHYSIOLOGY CATHETER
• Type of Device: CATHETER, ELECTRODE RECORDING, OR PROBE, 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: 5505083
• MDR Text Key: 40838076
• Report Number: 9673241-2016-00203
• Device Sequence Number: 1
• Product Code: DRF
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K080425
• 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: 01/27/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 07/31/2016
• Device Model Number: D-1285-02-S
• Device Catalogue Number: R7F282CT
• Device Lot Number: 17302810M
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/24/2016
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 01/27/2016
• Initial Date FDA Received: 03/16/2016
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 03/22/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/20/2015
• 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