MAUDE Adverse Event Report: BIOSENSE WEBSTER, INC. (JUAREZ) PENTARAY NAV ECO HIGH-DENSITY MAPPING CATHETER; CATHETER, INTRACARDIAC MAPPING, HIGH-DENSITY ARRAY

Model Number D-1282-10-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 09/10/2014

Event Type  malfunction  

Event Description

It was reported that a patient underwent an atrial fibrillation (afib) procedure with a pentaray navigational eco catheter.A returned catheter condition of foreign material found covering the irrigation tubing hole was noted.It was reported that magnetic sensor error was being displayed on the carto 3 system.The cable was replaced with no resolution.When the catheter was replaced, the issue resolved.The procedure was completed without patient consequence.The biosense webster failure analysis lab discovered yellowish and reddish brown material covering the irrigation tubing hole on (b)(6) 2014.The requested additional information was received.There were no patient consequences.Per the bwi clinical account specialist there was no issue with irrigation or occlusion.The foreign material was not noticed prior to use, upon withdrawal or prior to sending the catheter back.The foreign material is currently under analysis however based on the appearance of the material it appears likely to be dry blood.This event was originally considered non-reportable, however, bwi became aware of the foreign material when the product was returned on (b)(6) 2014 and have reassessed the event as reportable.The awareness date is being reset to (b)(6) 2014.

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 magnetic sensor error was displayed on the carto 3 system.Upon receipt, the catheter was visually inspected and yellowish and reddish brown material was found covering the irrigation tubing hole.This condition was not originally reported by the customer.Further information received indicates that the foreign material was not observed prior or upon removal of the catheter from the patient.An ft-ir test was performed in order to identify the type of foreign material; the results demonstrated that the particle found at the catheter was blood.Per the magnetic sensor error reported the catheter was evaluated for eeprom, and the functionality of the biosensor 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 failed during the biosensor functionality test.The catheter was then dissected and it was determined that the root cause was a biosensor wire broken at the connector.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 has been verified; however the root cause of the foreign material remains unknown.

• Brand Name: PENTARAY NAV ECO HIGH-DENSITY MAPPING CATHETER
• Type of Device: CATHETER, INTRACARDIAC MAPPING, HIGH-DENSITY ARRAY
• 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: 4263430
• MDR Text Key: 5007895
• Report Number: 9673241-2014-00504
• Device Sequence Number: 1
• Product Code: MTD
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K123837
• 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: 09/10/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/19/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 05/31/2017
• Device Model Number: D-1282-10-S
• Device Catalogue Number: D128210
• Device Lot Number: 17026297L
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/21/2014
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 09/10/2014
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/17/2014
• 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