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 11/08/2021

Event Type  Injury  

Event Description

It was reported that a (b)(6) female patient born on (b)(6) 1955 ((b)(6)) underwent an atrial fibrillation (afib) ablation procedure with a thermocool® smart touch® sf bi-directional navigation catheter and suffered st elevations requiring interventional cardiology and prolonged hospitalization.It was noted that this patient had a medical history of a previous heart bypass.During the procedure, an st elevation was noticed in the patient.When ablating, the physician had noticed st elevation on the "inferior leads" on the carto 3 and recording system.At this point, the physician suspected "some kind of coronary injury.An interventional cardiologist was called into the room.The patient was injected with dye in order to check for coronary blockage.The reporter believes that the coronary blockage may have been repaired, but the reporter was not able to confirm this information, as they were not in the room at this point.The patient is in stable condition.The physician¿s opinion on the cause of this adverse event is that this is ¿patient condition/unrelated¿.The patient outcome was reported as fully recovered.The patient required extended hospitalization for monitoring.

Manufacturer Narrative

Additional information received indicates that the device is not available for return, therefore no product investigation can be performed, and the customer complaint cannot be confirmed.A manufacturing record evaluation was performed for the finished device (b)(4) number, and no internal action 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 reference number: (b)(4).

Manufacturer Narrative

Additional information received indicates that the device is not available for return, therefore no product investigation can be performed, and the customer complaint cannot be confirmed.A manufacturing record evaluation was performed for the finished device 30598022l number, and no internal action 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 reference number: (b)(4).

Event Description

It was reported that a (b)(6) female patient born on (b)(6) 1955 ((b)(6)) underwent an atrial fibrillation (afib) ablation procedure with a thermocool® smart touch® sf bi-directional navigation catheter and suffered st elevations requiring interventional cardiology and prolonged hospitalization.It was noted that this patient had a medical history of a previous heart bypass.During the procedure, an st elevation was noticed in the patient.When ablating, the physician had noticed st elevation on the "inferior leads" on the carto 3 and recording system.At this point, the physician suspected "some kind of coronary injury.An interventional cardiologist was called into the room.The patient was injected with dye in order to check for coronary blockage.The reporter believes that the coronary blockage may have been repaired, but the reporter was not able to confirm this information, as they were not in the room at this point.The patient is in stable condition.The physician¿s opinion on the cause of this adverse event is that this is ¿patient condition/unrelated¿.The patient outcome was reported as fully recovered.The patient required extended hospitalization for monitoring.

• 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: 12920222
• MDR Text Key: 285247491
• Report Number: 2029046-2021-02097
• Device Sequence Number: 1
• Product Code: LPB
• UDI-Device Identifier: 10846835010183
• UDI-Public: 10846835010183
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P030031
• 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: 12/02/2021

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: 08/29/2022
• Device Model Number: D134805
• Device Catalogue Number: D134805
• Device Lot Number: 30598022L
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 11/08/2021
• Initial Date FDA Received: 12/02/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/30/2021
• 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: SMARTABLATE GENERATOR KIT-US.; UNK_CARTO 3.
• Patient Outcome(s): Required Intervention; Hospitalization
• Patient Age: 66 YR
• Patient Sex: Female
• Patient Weight: 60 KG