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 Problems Vasoconstriction (2126); Ischemic Heart Disease (2493)

Event Date 10/20/2021

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 reference number: (b)(4).

Event Description

It was reported that a (b)(6) year-old male patient ((b)(6) kg) underwent an atrial fibrillation (afib) ablation procedure with a thermocool® smart touch® sf bi-directional navigation catheter.The patient suffered st elevations, coronary artery spasm requiring intervention.St was elevated during af mapping at la.After coronary angiogram (cag), spasm was confirmed.Nitro was administered, and the symptoms subsided.The procedure was continued and completed.The physician commented that there is no causal relationship with the product.The event date: (b)(6) 2021.The adverse event was discovered during use of biosense webster products.The physician¿s opinion on the cause of this adverse event: the physician commented that the ae was not related to the bwi products.Intervention provided: after cag was performed, coronary spasm was observed.Nitroglycerin was administered.Patient outcome of the adverse event: improved.It was not reported extended hospitalization was required.Since the event is life threatening and might result in permanent impairment of a body function or permanent damage of a body structure, it is to be considered serious and mdr-reportable.

Manufacturer Narrative

On 24-nov-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 28-dec-2021, the product investigation was completed.It was reported that a 76-year-old male patient (57kg) underwent an atrial fibrillation (afib) ablation procedure with a thermocool® smart touch® sf bi-directional navigation catheter.The patient suffered st elevations, coronary artery spasm requiring intervention.St was elevated during af mapping at la.After coronary angiogram (cag), spasm was confirmed.Nitro was administered, and the symptoms subsided.The procedure was continued and completed.The physician commented that there is no causal relationship with the product.Device evaluation details: the device was returned to biosense webster for evaluation.A visual inspection, deflection, magnetic sensor functionality, screening, temperature and impedance, cool flow pump, patency, and ecg tests of the returned device were performed in accordance with bwi procedures.The smart touch bidirectional sf device was visually inspected, and it was found in good condition.The magnetic, temperature, and force features were tested, and no issues were observed.In addition, the catheter was deflecting and irrigating correctly.No malfunctions were observed during the product analysis.The issue reported by the customer could not be replicated during the product investigation; other issues or circumstances may have occurred during the usage of the device that compromised its performance.A manufacturing record evaluation was performed for the finished device 30571410l a number, and internal action 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).

• 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: 12785149
• MDR Text Key: 280583761
• Report Number: 2029046-2021-01930
• 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: 01/19/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/10/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 06/01/2022
• Device Model Number: D134801
• Device Catalogue Number: D134801
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/24/2021
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 12/28/2021
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/02/2021
• 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: PENTARAY NAV ECO
• Patient Outcome(s): Required Intervention; Life Threatening