MAUDE Adverse Event Report: BIOSENSE WEBSTER INC UNK_SMART TOUCH BIDIRECTIONAL SF; CARDIAC ABLATION PERCUTANEOUS CATHETER

Catalog Number UNK_SMART TOUCH BIDIRECTIONAL

Device Problem No Display/Image (1183)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 04/29/2020

Event Type  malfunction  

Manufacturer Narrative

The product was discarded, therefore no product failure analysis can be conducted and device malfunction cannot be confirmed.Since no lot number was provided, no manufacture record evaluation (mre) review could be performed.If additional information is received regarding this event, a supplemental 3500a report will be submitted to the fda.Manufacture reference no: (b)(4).

Event Description

It was reported that a patient underwent an ablation procedure for right atrial flutter with a unk_smart touch bidirectional sf catheter and no clear echocardiogram signal was observed.There was noise and no impedance readings on both carto 3 and recording system.The impedance cables were switched behind the generator and the issue remained.The cable from patient interface unit (piu) to smartablate was replaced and the issue resolved.The first issue at the beginning of the case was a lack of impedance values, both on carto and the recording system.The impedance cables were switched on the back of the smart ablate catheter (sa) because they had been connected in the wrong ports, but that did not resolve the issue.Then the impedance cables were changed, and that did not resolve the issue either.Lastly the piu to sa cable was changed, and that resolved the impedance issue.They were able to see the impedance values both on carto and the recording system.The observed no impedance has been assessed as not mdr reportable.When the rf ablation was turned on, there was had a noise issue.Every time the physician came on rf, this noise appeared on carto, the recording system, and on the anesthesia monitor, making it hard to monitor the patient¿s rhythm.This issue was not resolved.Reseating cables was attempted, ensuring the bs patches were adhered to the patient¿s body, and changing the ecg cables.None of these worked.The physician did not wish to change any cables or catheters, although this was suggested.The patient had a very smooth cti line and it did not take very long to finish the ablation.Thus, the physician did not want to do additional troubleshooting.The procedure was completed without consequence to the patient.The noise issue was not resolved.It is unknown if the noise issue was from a cable or a catheter.The following catheters and devices were in the body at the time of the noise: st.Jude medical inquiry catheter for the coronary sinus, an unk_c3 webster decapolar with auto id for the lower left right atrium, and a unk_smart touch bidirectional sf for ablation, in addition to a ramp sheath.Replacement was requested for the cable connecting the piu to the sa generator, which is never in the patient¿s body.

• Brand Name: UNK_SMART TOUCH BIDIRECTIONAL SF
• Type of Device: CARDIAC ABLATION PERCUTANEOUS CATHETER
• Manufacturer (Section D): BIOSENSE WEBSTER INC; 33 technology drive; irvine CA 92618
• Manufacturer (Section G): BIOSENSE WEBSTER INC (JUAREZ); circuito interior norte; 1820parque industrial salvacar; juarez 32599 ; MX 32599
• Manufacturer Contact: gabriel alfageme ; 31 technology drive; irvine, CA 92618 ; 949789-868
• MDR Report Key: 10094304
• MDR Text Key: 202032888
• Report Number: 2029046-2020-00627
• Device Sequence Number: 1
• Product Code: LPB
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 04/29/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/27/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: UNK_SMART TOUCH BIDIRECTIONAL
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 04/29/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1