MAUDE Adverse Event Report: BIOSENSE WEBSTER INC THERMOCOOL SMART TOUCH SF BI-DIRECTIONAL NAVIGATION CATHETER; CARDIAC ABLATION PERCUTANEOUS CATHETER

Model Number D134804

Device Problem No Display/Image (1183)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 08/26/2020

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

It was reported that a male patient ((b)(6) years old) underwent cardiac ablation procedure with a thermocool® smart touch® sf bi-directional navigation catheter where there was no signal available for the physician to monitor the patient¿s heart rhythm.Noise was observed in all signals of the inserted catheters (pentaray, decapolar and thermocool smartouch).It was observed in the remote control of smartablate generator that the ablation catheter showed a temperature error (indicated more than 100 degrees).The cable was changed, and the error continued.The catheter was changed, the error was solved, and the ablation could be completed.There was no report of patient consequence.The temperature issue was assessed as not mdr reportable.Since the user-defined cut-off was not exceeded, the potential that it could cause or contribute to a death, serious injury, or other significant adverse event, was remote.The signal issue was assessed as not mdr reportable as the risk to the patient was low.Additional information was received on september 2, 2020.The noise was observed in all the ecg lead: body surface (bs) and intracardiac (ic) channels.The noise was observed in carto and recording system as well.There was no was no signal available to monitor the patient¿s heart rhythm which includes no external signal available.The signals appeared and disappeared constantly.The catheter was inside the patient¿s body.It was confirmed that the smartablate remote control appeared an error and therefore, energy delivery was not allowed.The generator was in power control, at 45 w.Per the additional information stating that there was no signal available for the physician to monitor the patient¿s heart rhythm, the signal issue was assessed as mdr reportable.The awareness date for this reportable issue is september 2, 2020.

Manufacturer Narrative

The analysis has begun but is not 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.Manufacturer's reference number: (b)(4).

Manufacturer Narrative

Initially the lot number was not provided.During assessment by the biosense webster, inc.Analysis lab on (b)(6) 2020, the lot number was retrieved.Therefore, d4.Lot, d 4.Expiration date and h4.Device manufacture date have been populated.Device evaluation was completed on (b)(6) 2020.It was reported that a male patient (65 years old) underwent cardiac ablation procedure with a thermocool® smart touch® sf bi-directional navigation catheter where there was no signal available for the physician to monitor the patient¿s heart rhythm.It was observed in the remote control of smartablate generator that the ablation catheter showed a temperature error (indicated more than 100 degrees).The cable was changed, and the error continued.The catheter was changed, the error was solved, and the ablation could be completed.There was no report of patient consequence.The returned device was visually inspected and it was found in normal conditions.Per the event, the catheter was tested for electrical and stockert compatibility and it was found within specifications.Then, a cool flow pump test was performed and it was found within specifications, the catheter was irrigating correctly, no irrigation issues were observed.A manufacturing record evaluation was performed and no internal actions related to the reported complaint were identified.The customer complaint cannot be confirmed.If additional information is received regarding this event, a supplemental 3500a report will be submitted to the fda.Manufacturer's reference number: pc-000756160.

• Brand Name: THERMOCOOL SMART TOUCH SF BI-DIRECTIONAL NAVIGATION CATHETER
• Type of Device: CARDIAC ABLATION PERCUTANEOUS CATHETER
• Manufacturer (Section D): BIOSENSE WEBSTER INC; 33 technology drive; irvine CA 92618
• MDR Report Key: 10613412
• MDR Text Key: 209396376
• Report Number: 2029046-2020-01375
• Device Sequence Number: 1
• Product Code: LPB
• UDI-Device Identifier: 10846835010176
• UDI-Public: 10846835010176
• Combination Product (y/n): N
• PMA/PMN Number: P030031
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup,Followup
• Report Date: 08/26/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/01/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 03/04/2021
• Device Model Number: D134804
• Device Catalogue Number: D134804
• Device Lot Number: 30364332L
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/06/2020
• Date Manufacturer Received: 10/20/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: CARTO 3 SYSTEM; UNKNOWN BRAND CABLE; UNKNOWN BRAND CATHETER; UNKNOWN BRAND DECAPOLAR CATHETER; UNKNOWN BRAND RECORDING SYSTEM; UNK_PENTARAY; UNK_SMARTABLATE GENERATOR; CARTO 3 SYSTEM; UNKNOWN BRAND CABLE; UNKNOWN BRAND CATHETER; UNKNOWN BRAND DECAPOLAR CATHETER; UNKNOWN BRAND RECORDING SYSTEM; UNK_PENTARAY; UNK_SMARTABLATE GENERATOR
• Patient Age: 65 YR