MAUDE Adverse Event Report: BIOSENSE WEBSTER, INC. (JUAREZ) EZ STEER¿ NAV DS BI-DIRECTIONAL; CATHETER, PERCUTANEOUS, CARDIAC ABLATION, FOR TREATMENT OF ATRIAL FLUTTER

Model Number D-1260-04-S

Device Problems Device Inoperable (1663); Temperature Problem (3022)

Patient Problem Low Blood Pressure/ Hypotension (1914)

Event Date 07/11/2014

Event Type  Injury  

Event Description

It was reported that during an atrial fibrillation (afib) procedure, the catheter's temperature sensor was not working.The case was completed by replacing the catheter.Upon following up with the customer, bwi received additional information which is now indicative of a reportable event.The customer stated during the transeptal the patients¿ blood pressure dropped to the mid 50's and the st segment on the ecg was elevated.There was medical intervention was performed (unknown type and dosage).The physician indicated the afib procedure was cancelled.The patient stabilized and recovered normally.

Manufacturer Narrative

(b)(4).

Manufacturer Narrative

Manufacturer ref # (b)(4).It was reported that the catheter temperature sensor was not working.Also through an afib case, during the transeptal the patient¿s blood pressure dropped to the mid 50's and the smart touch segment on the ekg was elevated.The afib procedure was cancelled.The patient stabilized and recovered normally without intervention.The returned device was visually inspected upon receipt and it was found in normal conditions.Per the event, an irrigation test was performed and the catheter passed, no occlusion was observed.The catheter was also evaluated for eeprom, carto 3, and calibration functionality.The catheter was recognized by carto 3 system, no error messages were displayed and the catheter was properly visualized.Eeprom data demonstrates the catheter was properly calibrated during manufacturing.Furthermore, a deflection test was performed and the catheter passed.Finally, catheter was tested for electrical performance, stockert compatibility and thermal sensor response.The catheter failed on temperature test.Further investigation revealed that the thermocouple wires were broken.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 the temperature sensor has been verified.However the root cause of the adverse event remains unknown.

Manufacturer Narrative

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.(b)(4).

Manufacturer Narrative

The bwi failure analysis lab received the device for evaluation on (9/22/2014).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).

• Brand Name: EZ STEER¿ NAV DS BI-DIRECTIONAL
• Type of Device: CATHETER, PERCUTANEOUS, CARDIAC ABLATION, FOR TREATMENT OF ATRIAL FLUTTER
• 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 ; 15715 arrow highway; irwindale, CA 91706 ; 9098398483
• MDR Report Key: 3999005
• MDR Text Key: 4774289
• Report Number: 9673241-2014-00299
• Device Sequence Number: 1
• Product Code: OAD
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P010068/S6
• 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,Followup,Followup
• Report Date: 07/14/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/11/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 04/30/2017
• Device Model Number: D-1260-04-S
• Device Catalogue Number: BN7TCFJ8L
• Device Lot Number: 17020434M
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/22/2014
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 07/14/2014
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/03/2014
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Other; Required Intervention