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

Model Number D134805

Device Problem Patient Device Interaction Problem (4001)

Patient Problem Ischemic Heart Disease (2493)

Event Date 03/03/2022

Event Type  Injury  

Event Description

It was reported that a (b)(6) male patient (78 kg ) underwent an atrial fibrillation (afib) ablation procedure with a thermocool® smart touch® sf bi-directional navigation catheter and suffered st elevation requiring medical intervention.It was reported that in the inferior leads of the 12 lead ecg, st elevation occurred for about 3 minutes.After that, it recovered to a normal ecg.This occurred after the procedure, after the sheath was removed, during hemostasis.Coronary angiogram (cag) was performed, but no abnormal findings were observed.The 12 lead ecg also returned to normal, and patient left the room.The physician commented that the exact cause is unknown.This adverse event was discovered post use of biosense webster products.A smartablate generator was used.

Manufacturer Narrative

Initial reporter phone: (b)(6).The device has been reported as discarded, therefore no product investigation can be performed, and the customer complaint cannot be confirmed manufacturer's reference number: (b)(4).

Manufacturer Narrative

A manufacturing record evaluation was performed for the finished device number 30676421l and no internal action related to the complaint was found during the review.Additional information was received on 19-apr-2022.It was reported that the physician commented that he has no idea about the cause of the adverse event.The patient fully recovered (no residual effects).The patient has been discharged from the hospital and did not require extended hospitalization.There are no relevant tests/laboratory data or other relevant history.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; 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: michelleann garcia ; 31 technology dr; irvine, CA 92618 ; 6465917981
• MDR Report Key: 13951844
• MDR Text Key: 289907159
• Report Number: 2029046-2022-00676
• Device Sequence Number: 1
• Product Code: LPB
• UDI-Device Identifier: 10846835010183
• UDI-Public: 10846835010183
• 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
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 04/27/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/30/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 11/03/2022
• Device Model Number: D134805
• Device Catalogue Number: D134805
• Device Lot Number: 30676421L
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/30/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/04/2021
• 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
• Treatment: UNK_SMARTABLATE GENERATOR
• Patient Outcome(s): Other
• Patient Age: 71 YR
• Patient Sex: Male
• Patient Weight: 78 KG