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

Model Number D134702

Device Problem Patient Device Interaction Problem (4001)

Patient Problems Tachycardia (2095); Ischemic Heart Disease (2493)

Event Date 04/07/2022

Event Type  Injury  

Manufacturer Narrative

If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.Manufacturer's reference number: (b)(4).

Event Description

It was reported that a (b)(6) male patient ((b)(6) weight unit unknown if kg or lbs) underwent an atrial fibrillation (afib) ablation procedure with a thermocool® smart touch® sf uni-directional navigation catheter and suffered st depressions requiring surgical intervention and prolonged hospitalization.The patient also suffered non-sustained ventricular tachycardia (vt).After the procedure, they were removing catheters from the patient and gave protamine per the protocol and the patient had some acute st depression and rounds of non-sustained vt.All catheters were discarded and a surface echo (transthoracic echocardiogram), was done, and blood gases were drawn.The patient has a history of cad (coronary artery disease) and a stent in the circumflex artery.The interventional cardiologist and cardiac catheterization lab team were called, and the patient had an angioplasty where they confirmed the patient had a blockage.The patient had cardiac catheterization in the ep lab and then was transferred to the cardiac catheterization lab for stent placement.The patient was stable after leaving the ep lab.The patient became very hypotensive during the runs of vt and was given pressers and an arterial line was placed.The patient did not require defibrillation.They used a maximum of 40 watts.The physician¿s opinion on the cause of this adverse event was that it was patient condition related.The patient outcome is unknown.The patient required extended hospitalization because of the adverse event.

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) during an internal review on 04-may-2022, it was noted that the device has been reported as discarded and this information was not included on the initial 3500a report.Therefore, the product return status has been updated on this report.The device has been reported as discarded, therefore no product investigation can be performed, and the customer complaint cannot be confirmed.Manufacturing record evaluation (mre) cannot be conducted because no lot number was provided by the customer.

• Brand Name: THERMOCOOL® SMART TOUCH® SF UNI-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 ; 646591-798
• MDR Report Key: 14284481
• MDR Text Key: 290786259
• Report Number: 2029046-2022-00951
• Device Sequence Number: 1
• Product Code: LPB
• UDI-Device Identifier: 10846835009781
• UDI-Public: 10846835009781
• 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: Physician
• Type of Report: Initial,Followup
• Report Date: 05/31/2022

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 Model Number: D134702
• Device Catalogue Number: D134702
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 04/07/2022
• Initial Date FDA Received: 05/04/2022
• Supplement Dates Manufacturer Received: 05/04/2022
• Supplement Dates FDA Received: 05/31/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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 REMOTE SPARE-US.; UNK BAYLIS TRANSSEPTAL NEEDLE.; UNK_CARTO VIZIGO SHEATH.; UNK_PENTARAY.; UNK_SOUNDSTAR.
• Patient Outcome(s): Life Threatening; Required Intervention; Hospitalization
• Patient Age: 61 YR
• Patient Sex: Male