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

Catalog Number D132705

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

Patient Problems Death (1802); Encephalopathy (1833); Cardiac Tamponade (2226)

Event Date 08/05/2019

Event Type  Death  

Manufacturer Narrative

The product was discarded, therefore no product failure analysis can be conducted and device malfunction cannot be confirmed.  manufacturing record evaluation (mre) review cannot be conducted because no lot number was provided by the customer.Manufacturer's reference # (b)(4).

Event Description

It was reported that a (b)(6) year old male patient underwent a pulmonary vein isolation (pvi) ablation procedure with a thermocool® smart touch¿ bi-directional navigation catheter and suffered cardiac tamponade (requiring surgical intervention), anoxic encephalopathy and death.During the procedure, the physician made a little hole with the catheter (probably wrongly touched some tissue).This little hole resulted in bleeding and in oxygen deficiency and the patient needed surgical intervention (thoracoscopy) to close the tamponade.The hole could be restored and initially it seemed that the patient would recover well.Nevertheless, due to the oxygen deficiency, his organs were impacted, and the family decided that it would be better to stop the treatment and to let him pass away (sedation), which resulted in the death of the patient.The physician¿s opinion regarding the cause of the death is that it occurred due to brain hypo-perfusion due to reanimation and obstructive shock due to tamponade.No biosense webster, inc.Product malfunctions were reported during the case.The force visualization features used during the procedure were graph, vector, and visitag.The parameters for stability used with the visitag module were respiration adjustment, location stability: max distance change: 3mm; minimum time: 3s, fot: 25%, minimum 3g and tag index: enabled.The color option used prospectively was ablation index.

Manufacturer Narrative

After further review on november 4, 2019, it was determined that the patient code ¿hypoxic-ischaemic encephalopathy" was reported in error.As ¿hypoxic-ischaemic encephalopathy" is considered a cascade event due to cardiac tamponade.Manufacturer's reference # (b)(4).

Manufacturer Narrative

During an internal review on september 16, 2019, it was noted that section patient code, the code of "hypoxic-ischaemic encephalopathy" was inadvertently omitted, therefore, it has been populated.Manufacturer's reference # (b)(4).

• Brand Name: THERMOCOOL® SMART TOUCH¿ 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: 9060651
• MDR Text Key: 158599018
• Report Number: 2029046-2019-03638
• Device Sequence Number: 1
• Product Code: LPB
• UDI-Device Identifier: 10846835009200
• UDI-Public: 10846835009200
• Combination Product (y/n): N
• PMA/PMN Number: P030031/S053
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,other
• Type of Report: Initial,Followup,Followup
• Report Date: 08/21/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/15/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: D132705
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 11/04/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Death; Required Intervention
• Patient Age: 76 YR