MAUDE Adverse Event Report: BIOSENSE WEBSTER INC CARTO 3 SYSTEM; COMPUTER, DIAGNOSTIC, PROGRAMMABLE

Catalog Number FG540000

Device Problems Bent (1059); Device Issue (2379)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 12/12/2017

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.This carto 3 system was manufactured before september 24, 2016, therefore no udi is applicable for this product with serial (b)(4).

Event Description

It was reported that a patient underwent an ischemic ventricular tachycardia - left (l-isvt) procedure with a carto 3 system.It was reported that error code 7 was displayed on carto 3 system.The catheter cable was replaced and it was noticed that there was a bent pin in the piu.They straightened the pin without resolution.The system was then swapped out with a portable system.The bent pin issue was assessed as not reportable.Additional clarification was requested and received on the issue related to error 7.The response received confirmed that the error 7 was related to loss of electrograms and noise on the electrograms being displayed on both systems.It also confirmed that the physician did not have at least one ecg signal available to monitor patient heart rhythm.Since there were no signals available to the physician, this signal issue was assessed as a reportable malfunction.

Manufacturer Narrative

Investigation summary: it was reported that a patient underwent an ischemic ventricular tachycardia - left (l-isvt) procedure with a carto 3 system.It was reported that error code 7 was displayed on carto 3 system.The catheter cable was replaced and it was noticed that there was a bent pin in the piu.They straightened the pin without resolution.The system was then swapped out with a portable system.Additional clarification was requested and received on the issue related to error 7.The response received confirmed that the error 7 was related to loss of electrograms and noise on the electrograms being displayed on both systems.It also confirmed that the physician did not have at least one ecg signal available to monitor patient heart rhythm.The biosense webster field service engineer replaced the backplane card and tested the system according to the manual.All tests passed.Issue resolved.System is ready for use.Replaced backplane card was sent to the device manufacturer for further investigation.Per the device manufacturer, the customer complaint was confirmed.The backplane card map connector was found damaged.The card was repaired (b)(4).The device history record (dhr) review was performed by the manufacturer and no anomalies, which are related to the reported issue, were noted in manufacturing or servicing of this equipment.Manufacturer's ref.No: (b)(4).

• Brand Name: CARTO 3 SYSTEM
• Type of Device: COMPUTER, DIAGNOSTIC, PROGRAMMABLE
• Manufacturer (Section D): BIOSENSE WEBSTER INC; 33 technology drive; irvine CA 92618
• Manufacturer (Section G): BIOSENSE WEBSTER (ISRAEL) LTD.; 4 hatnufah street; yokneam 20667 17; IS 2066717
• Manufacturer Contact: joaquin kurz ; 33 technology drive; irvine, CA 92618 ; 949789-383
• MDR Report Key: 7144882
• MDR Text Key: 96124498
• Report Number: 2029046-2017-01313
• 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: 12/12/2017

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 Catalogue Number: FG540000
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 12/12/2017
• Initial Date FDA Received: 12/22/2017
• Supplement Dates Manufacturer Received: 12/12/2017
• Supplement Dates FDA Received: 02/14/2018
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1