MAUDE Adverse Event Report: BIOSENSE WEBSTER, INC. (JUAREZ) THERMOCOOL® SF NAV BI-DIRECTIONAL CATHETER; CARDIAC ABLATION PERCUTANEOUS CATHETER

Model Number D-1317-04-S

Device Problem Low impedance (2285)

Patient Problem Hypervolemia (2664)

Event Date 11/28/2014

Event Type  Injury  

Event Description

It was reported that a patient underwent a pulmonary veins isolation procedure with a thermocool® sf nav bi-directional catheter and device was showing very low impedance, after that the catheter disappeared on carto.These issues led to intra-procedural delay and as a result patient suffered hypervolemia which required a low dose of lasix and extended hospitalization.The patient¿s medical history is unknown.The procedure was completed successfully.The patient was reported to be in stable condition at the time the complaint was reported.The physician did not provide a causality opinion for the cause of this adverse event.Multiple attempts have been made to obtain additional information to this complaint.However, no further information has been made available.Per 21 cfr, part 803, this complaint is reportable.

Manufacturer Narrative

No device was received for analysis at the time of submission of the initial 3500a.Since the product was not returned for analysis, no product failure analysis can be conducted and no determination of possible contributing factors could be made.As such, the investigation will be closed.If the complaint device is received in the future we will reopen the complaint and perform the investigation as appropriate.(b)(4).As lot #:15886879l was provided, the device history record(s) 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.(b)(4).

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).

Manufacturer Narrative

(b)(4) it was reported that a patient underwent a pulmonary veins isolation procedure with a thermocool sf nav bi-directional catheter and device was showing very low impedance, after that the catheter disappeared on carto.These issues led to intra-procedural delay and as a result patient suffered hypervolemia which required a low dose of lasix and extended hospitalization.The bwi failure analysis lab received the device for evaluation.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.Furthermore, an irrigation test was performed and the catheter passed, no occlusion was observed.A deflection test was performed and the catheter passed.Finally, the catheter was tested for eeprom and biosensor functionality and carto.The catheter failed during biosensor functionality test.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.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 failed biosensor test functionality; however the root cause of the adverse event remains unknown.An internal corrective action has been opened to address a potential pcb issues/intermittency.

• Brand Name: THERMOCOOL® SF NAV BI-DIRECTIONAL CATHETER
• Type of Device: CARDIAC ABLATION PERCUTANEOUS CATHETER
• 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 3259 9; MX 32599
• Manufacturer Contact: jaime chavez ; 9098398483
• MDR Report Key: 4354424
• MDR Text Key: 5173832
• Report Number: 9673241-2014-00606
• Device Sequence Number: 1
• Product Code: LPB
• Combination Product (y/n): N
• Reporter Country Code: CA
• PMA/PMN Number: P030031/S025
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date: 12/01/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/22/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 06/30/2016
• Device Model Number: D-1317-04-S
• Device Catalogue Number: BNI35FJH
• Device Lot Number: 15886879L
• Other Device ID Number: (01)10846835003277
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 11/29/2014
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/11/2013
• 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): Life Threatening