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

Model Number D134801

Device Problem Patient Device Interaction Problem (4001)

Patient Problem Heart Block (4444)

Event Date 11/25/2021

Event Type  Injury  

Manufacturer Narrative

Initial reporter phone: (b)(6).If additional information is received regarding this event, a supplemental 3500a report will be submitted to the fda.Manufacturer's ref.# (b)(4).

Event Description

It was reported that a patient underwent a cardiac ablation procedure with a thermocool® smart touch® sf bi-directional navigation catheter and the patient suffered complete heart block requiring surgical intervention.It was reported that a patient suffered complete heart block during coronary sinus ablation.They completed the procedure by temporarily inserting pacemaker.Reporter stated there were plans to conduct permanent pacemaker implantation (pmi) tomorrow.Additional information was later received indicating that at the time of coronary sinus ostium (csos) ablation, the catheter was removed, and there was a possibility of septal ablation.There is a possibility that the catheter was missing when energized and the septal side was energized but it was later confirmed there was no product defects.The following day, pacemaker implantation (pmi) was performed.

Manufacturer Narrative

On 13-jan-2022, additional information about the patient and event were received.It was reported the patient was a 70-year-old male.The adverse event was discovered during use of biosense webster inc products.Bwi product malfunction was not reported.Pacemaker implantation (pmi) was performed.If additional information is received regarding this event, a supplemental 3500a report will be submitted to the fda.Manufacturer's ref.# (b)(4).

Manufacturer Narrative

It was reported that a patient underwent a cardiac ablation procedure with a thermocool® smart touch® sf bi-directional navigation catheter and the patient suffered complete heart block requiring surgical intervention.It was reported that a patient suffered complete heart block during coronary sinus ablation.They completed the procedure by temporarily inserting pacemaker.Reporter stated there were plans to conduct permanent pacemaker implantation (pmi).Bwi product malfunction was not reported.Pacemaker implantation (pmi) was performed.Device investigation details: since no device has been received for analysis, no product investigation can be performed, and the customer complaint cannot be confirmed.A manufacturing record evaluation was performed for the finished device 30620684l number, and no internal actions related to the complaint was found during the review.If additional information is received regarding this event, a supplemental 3500a report will be submitted to the fda.Manufacturer's ref.# (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; 31 technology drive, suite 200; 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 dr; irvine, CA 92618 ; 9497898687
• MDR Report Key: 13040857
• MDR Text Key: 287024483
• Report Number: 2029046-2021-02217
• Device Sequence Number: 1
• Product Code: LPB
• UDI-Device Identifier: 10846835010145
• UDI-Public: 10846835010145
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: P030031
• 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,Followup
• Report Date: 02/23/2022

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: 08/18/2022
• Device Model Number: D134801
• Device Catalogue Number: D134801
• Device Lot Number: 30620684L
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 11/25/2021
• Initial Date FDA Received: 12/19/2021
• Supplement Dates Manufacturer Received: 01/13/2022; 02/23/2022
• Supplement Dates FDA Received: 01/22/2022; 02/23/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/19/2021
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 70 YR
• Patient Sex: Male