MAUDE Adverse Event Report: BIOSENSE WEBSTER, INC. (JUAREZ) WEBSTER® CS CATHETER WITH AUTO ID TECHNOLOGY; CATHETER, ELECTRODE RECORDING, OR PROBE, ELECTRODE RECORDING

Model Number D-1353-04-S

Device Problem Signal Artifact/Noise (1036)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 08/17/2015

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 atrial fibrillation (afib) procedure with a webster coronary sinus with auto id catheter and there was noise on all electrodes.The patient was under general anesthesia for five hours.A transseptal puncture was performed.There was noise on all the intracardiac and body surface electrodes on both the carto system and the ge recording system.The physician did not have a good signal to continue the procedure.The cable was replaced and the issue did not resolve.Replacing the catheter resolved the issue.The procedure was completed with no patient consequence.The patient did not need additional hospitalization.The patient's heart rhythm was not visible to the operator.Lack of monitoring of the cardiac rhythm while devices are intracardiac might lead to undetected cardiac rhythm that can be life threatening.Therefore, this issue has been assessed as a reportable malfunction.

Manufacturer Narrative

(b)(4).It was reported that a patient underwent an atrial fibrillation (afib) procedure with a webster coronary sinus with auto id catheter and there was noise on all electrodes.The patient was under general anesthesia for five hours.A transseptal puncture was performed.There was noise on all the intracardiac and body surface electrodes on both the carto system and the ge recording system.The physician did not have a good signal to continue the procedure.The cable was replaced and the issue did not resolve.Replacing the catheter resolved the issue.The procedure was completed with no patient consequence.The patient did not need additional hospitalization.The returned device was visually inspected upon receipt and it was found green material on the connector pin.Due the foreign material, a scanning electron microscope (sem) analysis was requested.Results showed that the particle was composed of elemental carbon, oxygen, sodium, chlorine, nickel, copper and gold.Per the event, the catheter was tested for electrical performance and it was found within specifications.The device history record (dhr) was reviewed and no anomalies were found.In addition, the dhr review verifies that the device was manufactured in accordance with documented specification and procedures customer complaint cannot be confirmed.The root cause does not appear to be manufactured related.

• Brand Name: WEBSTER® CS CATHETER WITH AUTO ID TECHNOLOGY
• 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: shahe garabedian ; 9098397362
• MDR Report Key: 5079016
• MDR Text Key: 26243384
• Report Number: 9673241-2015-00632
• 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
• Report Date: 08/17/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/15/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 03/31/2018
• Device Model Number: D-1353-04-S
• Device Catalogue Number: D135304
• Device Lot Number: 17218939M
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/11/2015
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 08/17/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/14/2015
• 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