MAUDE Adverse Event Report: BIOSENSE WEBSTER, INC (IRWINDALE) CARTO® 3 SYSTEM ECO INTERFACE CABLE; CATHETER, ELECTRODE RECORDING OR PROBE, ELECTRODE RECORDING

Model Number D-1344-01-S

Device Problems Signal Artifact/Noise (1036); Device Displays Incorrect Message (2591)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 10/28/2015

Event Type  malfunction  

Manufacturer Narrative

The bwi failure analysis lab received the device for evaluation on 11/13/2015.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) methods: no testing methods performed.Results: no results available since no evaluation performed.Conclusion: device discarded by user, unable to follow-up.(b)(4).

Event Description

It was reported that error 116 (catheter sensor error) was being displayed on the carto 3 system.Noise from all ic and bs ecgs was displayed on the carto 3 system and on the recording system.The issue was seen only when the lasso catheter was connected to the c3 system.The issue was not resolved by changing to a new cable and a new lasso catheter.The issue was resolved by changing cable the third time.The procedure was completed without any patient's consequence.It's unknown whether there was other ecg signal available for physician to monitor the patient's heart rhythm (such as defibrillator, anesthesia monitor, etc.).Multiple attempts have been made to obtain clarification to this complaint.However, no further information has been made available.Bwi takes conservative approach to report this event under two cables which were used for trouble shooting.

Manufacturer Narrative

The device history record (dhr) for the lot number 17232880l has been reviewed and it was verified that device was manufactured in accordance with documented specifications and procedures.

Manufacturer Narrative

(b)(4).It was reported that error 116 (catheter sensor error) was being displayed on the carto 3 system.It was reported that noise from all ic and bs ecgs was displayed on the carto 3 system and on the recording system.Caller was transferred to css.Css: the issue was seen only when the lasso catheter was connected to the c3 system.With the catheter disconnected, the issue went away.The user tried a new cable and another lasso without resolution.The c3 system, v4 was rebooted without resolution, catheter/cable was moved from 20a to 20b without resolution, the error followed.The fse on call was conference in to assist.After extensive trouble shooting, the catheter cable was changed a 3rd time and the issue resolved.Replacement of the 2 lasso's used for trouble shooting requested.The new catheter cable replacement is also requested, 2 total.Case is proceeding without patient harm.The c3 is performing per specs.Upon receipt, the product was visually inspected and it was found in normal conditions.Carto test were performed and product passed all specification.No error found.Cable is working properly.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.Complaint was unable to duplicate.

• Brand Name: CARTO® 3 SYSTEM ECO INTERFACE CABLE
• Type of Device: CATHETER, ELECTRODE RECORDING OR PROBE, ELECTRODE RECORDING
• Manufacturer (Section D): BIOSENSE WEBSTER, INC (IRWINDALE); 15715 arrow highway; irwindale CA 91706
• Manufacturer (Section G): BIOSENSE WEBSTER, INC (IRWINDALE); 15715 arrow highway; irwindale CA 91706
• Manufacturer Contact: joaquin kurz ; 9497893837
• MDR Report Key: 5236887
• MDR Text Key: 32009240
• Report Number: 2029046-2015-00267
• Device Sequence Number: 1
• Product Code: DRF
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K113213
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date: 10/28/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/19/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 03/31/2016
• Device Model Number: D-1344-01-S
• Device Catalogue Number: D134401
• Device Lot Number: 17230207L
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/13/2015
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 10/28/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/16/2015
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1