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

Model Number D134804

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Arrhythmia (1721); No Code Available (3191)

Event Date 08/21/2020

Event Type  Injury  

Manufacturer Narrative

The device has been reported as discarded, therefore no product investigation can be performed, and the customer complaint cannot be confirmed.The "no code available" patient code is for the surgical intervention.A manufacturing record evaluation was performed for the finished device 30376758m 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 male patient underwent cardiac ablation procedure for premature ventricular contraction (pvc) with thermocool® smart touch® sf bi-directional navigation catheter and suffered complete heart block requiring pacemaker implantation.It was reported that during a pvc ablation while ablating the right coronary cusp, catheter stability was lost for 1 ms and energy delivery was stopped immediately.Heart block was noticed just before the occurrence.The patient went into complete heart block.A temporary pacer was inserted and the patient was admitted for observation.The caller stated that the patient was in 1st-degree av block at the start of the case.The catheter was discarded.The event occurred during use of biosense webster products.The patient¿s condition remained unchanged and intrinsic conduction had not been restored, so they were implanted with a permanent pacemaker on monday august 24 2020.The patient required an icu stay with a temporary pacemaker with a permanent device later implanted.Since this event may be life threatening; might result in permanent impairment of a body function or permanent damage to a body structure; or required medical or surgical intervention to preclude permanent impairment of a body function or permanent damage to a body structure it is mdr reportable.

• Brand Name: THERMOCOOL SMART TOUCH SF BI-DIRECTIONAL NAVIGATION CATHETER
• Type of Device: CARDIAC ABLATION PERCUTANEOUS CATHETER
• Manufacturer (Section D): BIOSENSE WEBSTER INC; 33 technology drive; 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 drive; irvine, CA 92618 ; 949789-868
• MDR Report Key: 10529201
• MDR Text Key: 207722962
• Report Number: 2029046-2020-01213
• Device Sequence Number: 1
• Product Code: LPB
• UDI-Device Identifier: 10846835010176
• UDI-Public: 10846835010176
• 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

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/14/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 05/26/2021
• Device Model Number: D134804
• Device Catalogue Number: D134804
• Device Lot Number: 30376758M
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 08/21/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/27/2020
• 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): Hospitalization; Required Intervention