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 Problems Stroke/CVA (1770); Death (1802)

Event Date 02/26/2019

Event Type  Death  

Manufacturer Narrative

No device was received for analysis at the time of submission of the initial 3500a.Since the product was not returned for analysis, no product failure analysis can be conducted and no determination of possible contributing factors could be made.As such the investigation will be closed.If the complaint device is received in the future we will reopen the complaint and perform the investigation as appropriate.A manufacturing record evaluation was performed for the finished device 30130877l number, and no non-conformances were found during the review.Concomitant medical products: visitag surpoint epu (us catalog # d160801, lot # unknown).Manufacturer's ref.# (b)(4).

Event Description

During a clinical trial sponsored by biosense webster inc.It was reported that an (b)(6)-year-old female patient underwent cardiac ablation procedure with a thermocool® smart touch® sf bi-directional navigation catheter and suffered left middle cerebral artery (mca) stroke (requiring a cerebral angiogram with mechanical thrombectomy) and death.Post-procedure, the patient suffered left middle cerebral artery (mca) stroke.A cerebral angiogram with mechanical thrombectomy was performed.Extended hospitalization was required as a result of the adverse event.At an unspecified point, the patient expired.The principal investigator assessed the event as severe in severity, serious, unrelated to the study device (visitag surpoint epu), unrelated to non-investigational bwi devices, possibly study catheter related, and probable index procedure related.

Manufacturer Narrative

On 3/22/2019, additional information was received indicating the lot # of the concomitant med product is 300100134l.Concomitant med product field is to be updated from "visitag surpoint epu (us catalog # d160801, lot # unknown)" to "visitag surpoint epu (us catalog # d160801, lot # 300100134l)" manufacturer's ref # (b)(4).

Manufacturer Narrative

On 5/22/2019, bionsense webster inc.Received additional information indicating the date of death was (b)(6) 2019.As such, date of death has been populated.Manufacturer¿s ref # (b)(4).

Manufacturer Narrative

On 4/28/2020, biosense webster inc.Received additional information which indicated that the principal investigator assessed the event as expected.If additional information is received regarding this event, a supplemental 3500a report will be submitted to the fda.Manufacturer¿s ref # (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.; 33 technology drive; irvine CA 92618
• MDR Report Key: 8445025
• MDR Text Key: 139598240
• Report Number: 2029046-2019-02866
• Device Sequence Number: 1
• Product Code: LPB
• UDI-Device Identifier: 10846835010183
• UDI-Public: 10846835010183
• Combination Product (y/n): N
• PMA/PMN Number: P030031
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,study
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 02/27/2019

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: 11/13/2019
• Device Model Number: D134805
• Device Catalogue Number: D134805
• Device Lot Number: 30130877L
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 02/27/2019
• Initial Date FDA Received: 03/22/2019
• Supplement Dates Manufacturer Received: 02/27/2019; 05/22/2019; 04/28/2020
• Supplement Dates FDA Received: 04/01/2019; 05/29/2019; 05/13/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Death; Hospitalization; Required Intervention
• Patient Age: 83 YR
• Patient Weight: 70