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

Model Number D134801

Device Problems Failure to Sense (1559); Patient Device Interaction Problem (4001)

Patient Problems Bradycardia (1751); Paralysis (1997); Perforation of Vessels (2135)

Event Date 02/16/2021

Event Type  Injury  

Manufacturer Narrative

(b)(6).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 an unknown patient underwent an unknown ablation with a thermocool® smart touch® sf bi-directional navigation catheter and suffered diaphragmatic paralysis, bradycardia, artery injury requiring a pacemaker implant.When the smart touch sf catheter was connected, 105 sensor error occurred when svc ablation.Connection was checked, the cable was changed, the issue was resolved by changing the catheter to another one after that, there was no abnormality with the product and the procedure was completed.Because bradycardia was also observed after stopping atrial fibrillation, pacemaker implant (pmi) was performed.Due to this, hospitalization was prolonged.Since the event is life threatening and required intervention and prolonged hospitalization to prevent permanent impairment of a body function or permanent damage to a body structure, is to be considered serious and mdr-reportable.

Manufacturer Narrative

On (b)(6) 2021, the bwi product analysis lab received the device for evaluation.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

On(b)(6) 2021, the product investigation was completed.It was reported that an unknown patient underwent an unknown ablation with a thermocool® smart touch® sf bi-directional navigation catheter and suffered diaphragmatic paralysis, bradycardia, artery injury requiring a pacemaker implant.When the smart touch sf catheter was connected, 105 sensor error occurred when svc ablation.Connection was checked, the cable was changed, the issue was resolved by changing the catheter to another one after that, there was no abnormality with the product and the procedure was completed.Because bradycardia was also observed after stopping atrial fibrillation, pacemaker implant (pmi) was performed.Due to this, hospitalization was prolonged.Device evaluation details: the product was returned to biosense webster for evaluation.Bwi conducted a visual inspection and a evaluation of all features of the catheter.Visual analysis of the returned product revealed that no damage or anomalies were observed on the smart touch sf (bidirectional) catheter.Per the event, several tests were performed.The magnetic, temperature and force features were tested and no issues were observed.In addition, the product was deflecting and irrigating correctly.No malfunctions were observed during the product analysis.A manufacturing record evaluation was performed for the finished device 30448171m number, and no internal actions related to the reported complaint condition were identified.No malfunction was observed during the product analysis.The instructions for use (ifu) states that careful catheter manipulation must be performed to avoid cardiac damage, perforation or tamponade.Regarding the magnetic sensor issue, the (ifu) contains the following warning stated in the carto 3 system manual, which it was performed for this product: if the problem persists, replace the catheter cable or the catheter.The root cause of the adverse event remains unknown.There may have been other circumstances or issues that occurred during the use of the device that could not be replicated during the analysis.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

On 5/7/2021, bwi received additional information indicating that the patient is male and the event occurred pre-use.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: 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: 11440491
• MDR Text Key: 240652032
• Report Number: 2029046-2021-00318
• Device Sequence Number: 1
• Product Code: LPB
• UDI-Device Identifier: 10846835010145
• UDI-Public: 10846835010145
• 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,Followup
• Report Date: 02/16/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 10/12/2021
• Device Model Number: D134801
• Device Catalogue Number: D134801
• Device Lot Number: 30448171M
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/25/2021
• Initial Date Manufacturer Received: 02/16/2021
• Initial Date FDA Received: 03/08/2021
• Supplement Dates Manufacturer Received: 03/25/2021; 04/13/2021; 05/07/2021
• Supplement Dates FDA Received: 04/08/2021; 05/06/2021; 05/10/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: CARTO 3 SYSTEM; UNSPECIFIED CATHETER CABLE
• Patient Outcome(s): Hospitalization; Life Threatening