MAUDE Adverse Event Report: BIOSENSE WEBSTER, INC. (IRWINDALE) CARTO 3; COMPUTER, DIAGNOSTIC, PROGRAMMABLE

Model Number D-1286-03-S

Device Problem Over-Sensing (1438)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 04/12/2017

Event Type  malfunction  

Manufacturer Narrative

We are working on the device history record (dhr) review.Once we get more information, it will be submitted in a supplemental.Manufacturer's ref.No:(b)(4).Biosense webster manufacturer's ref.No.'s:(b)(4).

Event Description

It was reported that a patient underwent an ablation procedure with a c3 interface cable where noise was experienced on all electrocardiogram (ecg) leads.During the procedure, interference was observed on all ecg leads, both body surface and intracardiac, for both the carto 3 and recording systems.No other ecgs were available to monitor the patient¿s heart rhythm.The catheter and catheter cable were both replaced, and the issue was resolved.No patient consequences were reported.The inability to monitor the patient¿s heart rhythm while devices are intracardiac can lead to undetected rhythms that could be life threatening.As a result, this event is mdr reportable.

Manufacturer Narrative

On 6/2/2017, biosense webster became aware that the lot number provided in the initial complaint file was not valid.Follow up attempts were made to retrieve the correct lot number, but it was not made available.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.Since no lot number was provided, no device history record (dhr) review could be performed.(b)(4).

Manufacturer Narrative

On 7/6/2017, 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

During product analysis, the lot number of the cable was determined to be 112370.Manufacturer¿s reference number: (b)(4) it was reported that a patient underwent an ablation procedure with a c3 interface cable where noise was experienced on all electrocardiogram (ecg) leads.Upon receipt, the product was visually inspected, and was found in normal condition.A carto 3 system test was performed, and the product passed all specification.No errors were found, and the cable was found to be 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.The customer complaint could not be confirmed.

• Brand Name: CARTO 3
• Type of Device: COMPUTER, DIAGNOSTIC, PROGRAMMABLE
• 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 ; 33 technology drive; irvine, CA 92618 ; 9497893837
• MDR Report Key: 6558974
• MDR Text Key: 75033500
• Report Number: 2029046-2017-00159
• Device Sequence Number: 1
• Product Code: DQK
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: K090017
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 04/13/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: D-1286-03-S
• Device Catalogue Number: CR3434CT
• Device Lot Number: OEM_D-1286-03-S
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/06/2017
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 04/12/2017
• Initial Date FDA Received: 05/10/2017
• Supplement Dates Manufacturer Received: Not provided; 04/12/2017; 04/12/2017
• Supplement Dates FDA Received: 06/20/2017; 07/07/2017; 10/23/2017
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: No
• Type of Device Usage: N
• Patient Sequence Number: 1