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

Model Number D134805

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

Patient Problem Inflammation (1932)

Event Date 12/12/2019

Event Type  Injury  

Manufacturer Narrative

Device investigation details: 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 number 30252250m, and no internal actions related to the reported 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 ref.# (b)(4).

Event Description

During a clinical trial, sponsored by bwi, a serious injury of pericarditis occurred post use of a thermocool® smart touch® sf bi-directional navigation catheter.Unspecified medication was required as intervention.It was reported that a (b)(6) year-old male patient underwent a cardiac ablation procedure on (b)(6) 2019.On (b)(6) 2019, post-procedure day 1 the patient developed pericarditis.Intervention was unspecified medication.Additional hospitalization was not required.The issue has resolved.The principal investigator assessed this event as expected, moderate in severity, not serious, and not related to study device (visitag surpoint epu), not related to the study catheters, not related to the biosense webster non-investigational device (e.G.Pump, tubing, cables etc) and causally related to index procedure.It was reported that 89 radiofrequency ablations were performed with the thermocool® smart touch® sf bi-directional navigation catheter.No device deficiency was noted.Since the event implies relationship to procedure and it required medical intervention to preclude permanent impairment of a body function or permanent damage to a body structure it is considered to be 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: 9934341
• MDR Text Key: 193426496
• Report Number: 2029046-2020-00524
• Device Sequence Number: 1
• Product Code: LPB
• UDI-Device Identifier: 10846835010183
• UDI-Public: 10846835010183
• 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: health professional,study
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 03/13/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/08/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 07/02/2020
• Device Model Number: D134805
• Device Catalogue Number: D134805
• Device Lot Number: 30252250M
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 03/13/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/03/2019
• 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): Other; Required Intervention
• Patient Age: 49 YR
• Patient Weight: 93