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 Inflammation (1932); Heart Failure (2206)

Event Date 03/20/2020

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.A manufacturing record evaluation was performed for the finished device 30266310m 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

During a clinical trial, sponsored by bwi, it was reported that an (b)(6) female patient (5.42 ft, (b)(6)) underwent a pulmonary vein isolation (pvi) ablation procedure on (b)(6) 2019 with a thermocool® smart touch® sf bi-directional navigation catheter and suffered pericarditis and heart failure.During the procedure a total of 51 radiofrequency applications were done with the stsf catheter.No device deficiencies were reported.The procedure was successfully completed without patient consequences.Post-procedure ((b)(6) 2020), the patient developed pericarditis (ae8) and heart failure (ae11).Unspecified medication was administered.Prolonged hospitalization was required.Patient was discharged on (b)(6) 2020.The principal investigator assessed the events as severe, serious, not expected, possible related to the study device (visitag surpoint epu), possible related to the study catheter, not related to the bwi non-investigational devices (e.G pump, tubing, cables, etc), and causal related to repeat procedure ((b)(6) 2020).Issues were resolved.Since intervention and prolonged hospitalization was required to prevent permanent impairment of a body function or permanent damage to a body structure, this event is being considered serious and 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: 10848773
• MDR Text Key: 217095514
• Report Number: 2029046-2020-01738
• 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,study
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 10/20/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/16/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 07/25/2020
• Device Model Number: D134804
• Device Catalogue Number: D134804
• Device Lot Number: 30266310M
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 10/20/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/26/2019
• 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; Life Threatening; Required Intervention
• Patient Age: 82 YR
• Patient Weight: 91