MAUDE Adverse Event Report: BIOSENSE WEBSTER (ISRAEL) LTD. CARTO® 3 SYSTEM; COMPUTER, DIAGNOSTIC, PROGRAMMABLE

Model Number M-4800-01

Device Problem Malposition of Device (2616)

Patient Problem No Patient Involvement (2645)

Event Date 02/22/2016

Event Type  malfunction  

Manufacturer Narrative

The hardware investigation has begun but it has not been completed at this time.When the investigational analysis has been completed, a supplemental 3500a report will be submitted.Concomitant products: pentaray catheter.Smart touch catheter.(b)(4).

Event Description

It was reported that a patient underwent an atrial fibrillation (afib) procedure with a carto 3 system.Three separate pentaray maps were created of the left atrium.Then the physician proceeded to do a cryo balloon ablation.After the cryo was completed, the smart touch ablation catheter was introduced into the left atrium.While trying to position the catheter on the septum and left atrium ridge, everything seemed off.A map shift was noted as there was a large shift between the maps.Everything shifted rightwards and forward.There was no error message and no patient movement.At this point, they switched out the ablation catheter for the pentaray catheter and then again re-did the fast anatomical map (fam) on the left atrium.The procedure was completed with no patient consequence.Since this map shift occurred with no error message and there was no patient movement reported, this type of map shift could potentially be caused by a system malfunction and there would be a potential risk to the patient.Therefore, this issue is being assessed as a reportable malfunction.

Manufacturer Narrative

(b)(4).It was reported that a patient underwent an atrial fibrillation (afib) procedure with a carto 3 system.Three separate pentaray maps were created of the left atrium.Then the physician proceeded to do a cryo balloon ablation.After the cryo was completed, the smart touch ablation catheter was introduced into the left atrium.While trying to position the catheter on the septum and left atrium ridge, everything seemed off.A map shift was noted as there was a large shift between the maps.Everything shifted rightwards and forward.There was no error message and no patient movement.At this point, they switched out the ablation catheter for the pentaray catheter and then again re-did the fast anatomical map (fam) on the left atrium.The procedure was completed with no patient consequence.The biosense webster field service engineer contacted the biosense webster field representative to follow up on the issue.The biosense webster field service engineer was informed by the biosense webster field representative that several cases were performed with no issues related to complaint.The biosense webster field representative does not want further investigation unless the problem reoccurs.The system is operational.The device history record (dhr) review was performed by the manufacturer and no anomalies were noted in manufacturing or servicing of this equipment.

• Brand Name: CARTO® 3 SYSTEM
• Type of Device: COMPUTER, DIAGNOSTIC, PROGRAMMABLE
• Manufacturer (Section D): BIOSENSE WEBSTER (ISRAEL) LTD.; 4 hatnufah street; yokneam 20667 17; IS 2066717
• Manufacturer (Section G): BIOSENSE WEBSTER (ISRAEL) LTD.; 4 hatnufah street; yokneam 20667 17; IS 2066717
• Manufacturer Contact: joaquin kurz ; 9497893837
• MDR Report Key: 5486592
• MDR Text Key: 40243282
• Report Number: 3008203003-2016-00007
• Device Sequence Number: 1
• Product Code: DQK
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K133916
• 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: 02/22/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/08/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: M-4800-01
• Device Catalogue Number: FG540000
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 02/22/2016
• Was Device Evaluated by Manufacturer?: Yes
• Type of Device Usage: Reuse
• Patient Sequence Number: 1