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

Model Number M-4800-01

Device Problems Entrapment of Device (1212); Unintended Collision (1429); Difficult to Remove (1528)

Patient Problem No Code Available (3191)

Event Date 09/25/2014

Event Type  Injury  

Event Description

It was reported that a patient underwent an atrial fibrillation procedure with a lasso¿ 2515 variable circular mapping catheter and carto® 3 system and the catheter got entangled in mitral valve apparatus.During the procedure, the lasso catheter due to manipulation was entangled in the mitral valve apparatus.In addition, the lasso loop appeared on carto system as if on normal plane while under fluoroscopy, loop was distorted.The patient underwent surgical intervention in order to remove the catheter.The patient was reported to be recovered at the time bwi followed-up with the physician; the patient required hospitalization.The physician¿s opinion regarding the cause of this adverse event is that this is procedure and product related.The physician stated the risks involved in this type of procedure and aware of the guidelines when using the lasso catheter in the la anatomy.The instruction for use (ifu) recommends that a careful catheter manipulation must be performed in order to avoid cardiac damage, perforation, or tamponade.The lasso catheter is not recommended for use in the ventricles.Bwi determined to take a conservative approach and therefore reported carto 3 system, even though there is no sufficient evidence whether our equipment may have contributed to the reported event.

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 bwi products: product: thermocool® smart touch¿ bi-directional navigation catheter us catalog # d132705 lot # unknown manufacturer's reference # (b)(4) and (b)(4), are related to the same event d) manufacturer's reference # (b)(4).

Manufacturer Narrative

(b)(4).It was reported that a patient underwent an atrial fibrillation procedure with a lasso¿ 2515 variable circular mapping catheter and carto® 3 system and the catheter got entangled in mitral valve apparatus.During the procedure, the lasso catheter due to manipulation was entangled in the mitral valve apparatus.In addition, the lasso loop appeared on carto system as if on normal plane while under fluoroscopy, loop was distorted.The patient underwent surgical intervention in order to remove the catheter.The patient was reported to be recovered at the time bwi followed-up with the physician; the patient required hospitalization.The physician¿s opinion regarding the cause of this adverse event is that this is procedure and product related.The physician stated the risks involved in this type of procedure and aware of the guidelines when using the lasso catheter in the la anatomy.The instruction for use (ifu) recommends that a careful catheter manipulation must be performed in order to avoid cardiac damage, perforation, or tamponade.The lasso catheter is not recommended for use in the ventricles.Bwi determined to take a conservative approach and therefore reported carto 3 system, even though there is no sufficient evidence whether our equipment may have contributed to the reported event.The investigational analysis has been completed.The log files and recordings could not be exported from the system due to regulatory hold following a defect identified in the anonymize feature.Field service engineer (fse) contacted the local team and they confirmed that the system was used for several cases after the event without further issues.The system is working normally.The history of customer complaints associated with carto 3 system # (b)(4) was reviewed.Out of (b)(4) additional reported complaints, no additional complaint that may be related to the reported issue was identified.A device history record review was performed by the manufacturer and no anomalies were noted in manufacturing or servicing of this equipment.The customer complaint was not confirmed.Management is notified of failure analysis through the monthly trending reports.No significant trends have been identified at this time; therefore, no capa activity is required.

• 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 2066 717; IS 2066717
• Manufacturer Contact: jaime chavez ; 15715 arrow highway; irwindale, CA 91706 ; 9098398483
• MDR Report Key: 4200712
• MDR Text Key: 5150984
• Report Number: 3008203003-2014-00069
• Device Sequence Number: 1
• Product Code: DQK
• Combination Product (y/n): N
• Reporter Country Code: UK
• PMA/PMN Number: K133916
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 09/26/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/24/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• 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: 09/25/2014
• Was Device Evaluated by Manufacturer?: Yes
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Life Threatening; Required Intervention
• Patient Age: 74 YR
• Patient Weight: 70