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

Model Number D134805

Device Problems Adverse Event Without Identified Device or Use Problem (2993); No Apparent Adverse Event (3189)

Patient Problems Inflammation (1932); Cardiac Tamponade (2226)

Event Date 06/12/2019

Event Type  Injury  

Manufacturer Narrative

The product was discarded, therefore no product failure analysis can be conducted and device malfunction cannot be confirmed.If additional information is received regarding this event, a supplemental 3500a report will be submitted to the fda.A manufacturing record evaluation was performed for the finished device 30220986m number, and no internal action related to the complaint was found during the review.Manufacturer's ref.# (b)(4).

Event Description

It was reported that a (b)(6)-year-old female patient (175 cms, (b)(6)) underwent a cardiac ablation procedure on (b)(6) 2019 with a thermocool® smart touch® sf bi-directional navigation catheter and suffered cardiac tamponade requiring pericardiocentesis with drain placed and medication.About one month after the procedure ((b)(6) 2019), the patient suffered cardiac tamponade.An unspecified medication was administered.Pericardiocentesis with drain in place was performed to remove an unknown amount of fluid from the pericardial space.Extended hospitalization was required.Issue was resolved.The principal investigator assessed this event as severe, serious, not related to the study device (visitag surpoint epu), not related to the study catheters, not related to the bwi non-investigational devices and causal index procedure related.

Manufacturer Narrative

On 12/17/2019, it was noticed that the following concomitant products were omitted from the 3500a initial mdr.They have now been added to section d11.Concomitant med.Products.1.Smartablate generator kit-us.2.Cbl, 34 hyp/34 lemo, 10'.3.Carto3 external refpatch 6pack.4.Smartablate pump kit-us.Manufacturer¿s ref # (b)(4).

Manufacturer Narrative

On(b)(6)2020 , biosense webster inc.Received additional information indicating on post-procedure day 2 (06/13/2019), the patient developed pericarditis.Unspecified medication was administered.Extended hospitalization was not required.Issue was not resolved.The principal investigator assessed this event as expected, mild in severity, not serious, unrelated to the study device, study catheter, bwi non-investigational devices and causal index procedure related.On (b)(6)2020 is when additional information was received indicating the relationship to the procedure was updated from ¿not related¿ to ¿causal relationship¿.On (b)(6)2020 , additional information was received indicating that medication was not provided to the patient as part of treatment for the cardiac tamponade adverse event.If additional information is received regarding this event, a supplemental 3500a report will be submitted to the fda.Manufacturer's ref.# (b)(4).

Manufacturer Narrative

On 8/5/2020, biosense webster inc.Received additional information regarding the adverse event of pericarditis indicating the severity has been reassessed from mild to moderate in severity.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: 8881317
• MDR Text Key: 154106329
• Report Number: 2029046-2019-03538
• 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: 06/25/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/09/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 05/08/2020
• Device Model Number: D134805
• Device Catalogue Number: D134805
• Device Lot Number: 30220986M
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 08/05/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: CARTO 3 SYSTEM; CARTO3 EXTERNAL REFPATCH 6PACK; CBL, 34 HYP/34 LEMO, 10'; SMARTABLATE GENERATOR KIT-US; SMARTABLATE PUMP KIT-US
• Patient Outcome(s): Hospitalization; Life Threatening; Required Intervention
• Patient Age: 63 YR
• Patient Weight: 96