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 Vascular Dissection (3160); Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Date 06/04/2021

Event Type  Injury  

Manufacturer Narrative

Initial reporter phone: (b)(6).(b)(4).The device has been reported as discarded, therefore no product investigation can be performed, and the customer complaint cannot be confirmed.A manufacturing record evaluation was performed for the finished device 30518180m 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.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)-year-old female (53kg) patient underwent a premature ventricular contraction (pvc) ablation procedure with a thermocool¿ smart touch¿ sf bi-directional navigation catheter and suffered st elevations, a left anterior descending (lad) injury requiring a percutaneous coronary intervention (pci).When the product was used in the aorta, the catheter may have hit the left main trunk (lmt) with a strong contact when the operation around the aortic valve was difficult.The event occurred after completion of catheter ablation (abl) and ventricular tachycardia (vt) study.The st elevation was confirmed by surface electrocardiogram.An emergency pci was performed for the left anterior descending (lad) injury.The physician commented that although there is no complaint such as defect or defect of the product itself, they recognize that this event occurred as a result of difficulty in operation of this product.This adverse event was discovered post use of biosense webster inc.(bwi) products.The physicians opinion on the cause of this adverse event was that it was procedure related.The physician did not consider that there was a defect or product malfunction in the bwi product, but he considered that this adverse event occurred as a result of difficulty in manipulating the product.Patient outcome was reported as improved.It was not reported that the patient required extended hospitalization because of the adverse event.

• 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 ; MX
• Manufacturer Contact: gabriel alfageme ; 31 technology dr; irvine, CA 92618 ; 9497898687
• MDR Report Key: 12173916
• MDR Text Key: 261718320
• Report Number: 2029046-2021-01043
• 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
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 06/04/2021

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: 03/09/2022
• Device Model Number: D134801
• Device Catalogue Number: D134801
• Device Lot Number: 30518180M
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 06/04/2021
• Initial Date FDA Received: 07/15/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/10/2021
• 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): Life Threatening; Required Intervention
• Patient Age: 30 YR
• Patient Weight: 53