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

Model Number M-4800-01

Device Problem Positioning Problem (3009)

Patient Problem Ventricular Tachycardia (2132)

Event Date 01/27/2015

Event Type  malfunction  

Event Description

It was reported that during an idiopathic ventricular tachycardia (idvt) procedure, the customer experienced a map shift on the carto 3 system without any error.This malfunction is indicative of a reportable event.The physician was unable to place the catheter where prior points had been taken during ablation.The map shift was approximately 1 cm.The case was completed conventionally without any patient consequence.

Manufacturer Narrative

(b)(4).

Manufacturer Narrative

Refer to evaluation summary manufacturer ref # (b)(4) it was reported that during an idiopathic ventricular tachycardia (idvt) procedure, the customer experienced a map shift on the carto 3 system without any error.This malfunction is indicative of a reportable event.The physician was unable to place the catheter where prior points had been taken during ablation.The map shift was approximately 1cm.The case was completed conventionally without any patient consequence.The carto manufacturer (htc) opened investigation for this repeatable issue.Htc contacted local clinical support specialist (css) and determined that map shifts happened due to the patients were straining or holding their breath.Once the patients relaxed the map became aligned and no map shifts occurred then.Css informed there were no more map shifts since they understood the reason of the issue.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 2066 717; IS 2066717
• Manufacturer (Section G): BIOSENSE WEBSTER (ISRAEL) LTD.; 4 hatnufah street; yokneam 2066 717; IS 2066717
• Manufacturer Contact: jaime chavez ; 9098398483
• MDR Report Key: 4513986
• MDR Text Key: 5488665
• Report Number: 3008203003-2015-00006
• 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: 01/28/2015

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: M-4800-01
• Device Catalogue Number: FG540000
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 01/27/2015
• Initial Date FDA Received: 02/12/2015
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 07/24/2015
• Was Device Evaluated by Manufacturer?: Yes
• Type of Device Usage: Reuse
• Patient Sequence Number: 1