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

Model Number FG540000

Device Problem Appropriate Term/Code Not Available (3191)

Patient Problem Low Blood Pressure/ Hypotension (1914)

Event Date 11/20/2019

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.If additional information is received regarding this event, a supplemental 3500a report will be submitted to the fda.(b)(4).

Event Description

It was reported that a patient underwent an atrial fibrillation ablation procedure with a carto® 3 system and suffered hypotension.During transesophageal echo study, with the patient under general anesthesia (20-30 min) the carto® 3 system displayed a chest patch sensor error.The patient interface unit (piu) was turned off and the green and yellow sensor cables reseated in piu.The piu and workstation were rebooted along with the patch unit being reseated.The issue did not resolve.They will borrow a set of yellow sensor cables and a patch unit from another hospital.They will also swap the green and yellow sensor cables for testing purposes.The yellow patch cables did not seem to sit tightly into the patch unit.The patient¿s blood pressure was unstable, and the anesthesia was getting anxious.It was going to take at least 30 minutes to get a patch cable from another hospital.Therefore, the physician said to take the patient off the table and cancel the case.The cable was eventually borrowed from another hospital to do the next procedure.In the physician¿s opinion, the cancellation of the procedure did not contribute to a serious injury of the patient.The patient was hospitalized overnight but no procedure other than the transesophageal echocardiogram (tee) was performed.The patch sensor error was assessed as not reportable.Since it was not life threatening, did not result in permanent impairment of a body function or permanent damage to a body structure; or did not necessitate medical or surgical intervention to preclude permanent impairment of a body function or permanent damage to a body structure, the potential risk that it could cause or contribute to a serious injury or death to the operator or patient was remote.There is no indication that the patient¿s hypotension resulted from the use of the system; therefore, the carto® 3 system will be considered concomitant for the patient event and not reportable.The issue assessed as reportable was the procedure cancellation after extended general anesthesia time.

Manufacturer Narrative

Investigation summary: it was reported that a patient underwent an atrial fibrillation ablation procedure with a carto® 3 system.During transesophageal echo study, with the patient under general anesthesia (20-30 min) the carto® 3 system displayed a chest patch sensor error.The patient interface unit (piu) was turned off and the green and yellow sensor cables reseated in piu.The piu and workstation were rebooted along with the patch unit being reseated.The issue did not resolve.They will borrow a set of yellow sensor cables and a patch unit from another hospital.They will also swap the green and yellow sensor cables for testing purposes.The yellow patch cables did not seem to sit tightly into the patch unit.The patient¿s blood pressure was slightly low, and the patient was not tolerating being under anesthesia very well.The anesthesia was getting anxious.It was going to take at least 30 minutes to get a patch cable from another hospital.Therefore, the physician said to take the patient off the table and cancel the case.No sheaths or catheters were in the patient at the time the procedure was cancelled.The cable was eventually borrowed from another hospital to do the next procedure.The biosense webster field service engineer confirmed that the customer ordered a yellow patch sensor cable and this resolved the issue.System is ready for use.The complaint history of the system was reviewed, and no more similar problems were found since the issue occurred.The faulty yellow patch sensor cable was sent to the device manufacturer for investigation.The customer complaint was confirmed.During visual inspection, the plastic isolation of the yellow patch sensor cable patch #5 was found physically damaged close to the patch sensor.The same place on patch #5 was checked by x-ray and damage of inner wire was confirmed in the same location.In the physician¿s opinion, the cancellation of the procedure did not contribute to a serious injury of the patient.The patient was hospitalized overnight but no procedure other than the transesophageal echocardiogram (tee) was performed.There is no indication that the patient¿s hypotension resulted from the use of the system; therefore, the carto® 3 system will be considered concomitant.A manufacturing record evaluation was performed for the finished device number #13484, and no internal actions related to the reported complaint condition were identified.Manufacturer's reference number: (b)(4).

Manufacturer Narrative

Additional information was provided on the event on (b)(6)2019.The patient¿s blood pressure was slightly low, and the patient was not tolerating being under anesthesia very well.No sheaths or catheters were in the patient at the time the procedure was cancelled.In addition, the physician contact information was provided on 12/18/2019.Therefore, processed e1.Initial reporter title, e1.Initial reporter first name, e1.Initial reporter last name, e1.Initial reporter phone, e1.Initial reporter email, e2.Health professional? and e3.Initial reporter occupation.The manufactured date was provided on 12/22/2019.Therefore, processed h4.Device manufacture date.If additional information is received regarding this event, a supplemental 3500a report will be submitted to the fda.Manufacturer¿s reference number: (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
• MDR Report Key: 9491919
• MDR Text Key: 199723482
• Report Number: 2029046-2019-04023
• Device Sequence Number: 1
• Product Code: DQK
• UDI-Device Identifier: 10846835000870
• UDI-Public: 10846835000870
• Combination Product (y/n): N
• PMA/PMN Number: K133916
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Type of Report: Initial,Followup,Followup
• Report Date: 11/20/2019

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: FG540000
• Device Catalogue Number: FG540000
• Initial Date Manufacturer Received: 11/20/2019
• Initial Date FDA Received: 12/18/2019
• Supplement Dates Manufacturer Received: 12/18/2019; 02/18/2020
• Supplement Dates FDA Received: 01/10/2020; 02/20/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1