MAUDE Adverse Event Report: BIOSENSE WEBSTER INC THERMOCOOL® SF NAV UNI-DIRECTIONAL CATHETER; CARDIAC ABLATION PERCUTANEOUS CATHETER

Catalog Number UNK_THERMOCOOL SF NAV

Device Problem Patient Device Interaction Problem (4001)

Patient Problems Fistula (1862); Pericardial Effusion (3271)

Event Date 11/30/2018

Event Type  Injury  

Manufacturer Narrative

Manufacturer's ref.No: pc-(b)(4).This complaint is from a literature source.The following literature cite has been reviewed: use of high-density activation and voltage mapping in combination with entrainment to delineate gap-related atrial tachycardias post atrial fibrillation ablation.Pmid: 33564832 doi: 10.1093/europace/euaa394.Since no device has been received for analysis, no product investigation can be performed, and the customer complaint cannot be confirmed.Manufacturing record evaluation (mre) cannot be conducted because no lot number was not provided by the customer.

Event Description

This complaint is from a literature source.The following literature cite has been reviewed: use of high-density activation and voltage mapping in combination with entrainment to delineate gap-related atrial tachycardias post atrial fibrillation ablation.Pmid: 33564832 doi: 10.1093/europace/euaa394 objective/methods/study data: aims: the mechanisms of at using ultra-high-resolution mapping in a large cohort of patients was evaluated after af ablation.Methods: consecutive patients who underwent radiofrequency catheter ablation for endocardial gap related at post-af ablation were included in the study between january 2016 and november 2018.A 3.5-mm tip open-irrigated catheter (thermocool sf, biosense webster, diamond bar, ca, usa) was used for procedures using rhythmia and carto, and a pressure sensing 3.5mm irrigated tip ablation catheter with 2-2-2mm interelectrode spacing (tacticath, abbott technologies, minneapolis, mn, usa) was used for ensite precision.Lot, model and catalog number are not available, but the suspected biosense device possibly associated with reported adverse events: ablation catheter navistar thermo- cool; biosense webster concomitant other biosense webster devices that were also used in this study: carto system, pentaray mapping catheter.Concomitant non-biosense webster devices that were also used in this study: ablation catheter tacticath, abbotttechnologies.Adverse event(s) and provided interventions: it was reported that a patient who underwent radiofrequency catheter ablation has experienced a femoral arterio-venous fistula not requiring intervention.It was also reported that two patients who underwent radiofrequency catheter ablation have experienced pericardial effusion <1 cm not requiring drainage.

• Brand Name: THERMOCOOL® SF NAV UNI-DIRECTIONAL CATHETER
• Type of Device: CARDIAC ABLATION PERCUTANEOUS CATHETER
• Manufacturer (Section D): BIOSENSE WEBSTER INC; 31 technology drive, suite 200; irvine CA 92618
• Manufacturer (Section G): BIOSENSE WEBSTER INC (JUAREZ); circuito interior norte; 1820parque industrial salvacar; juarez 32599 ; MX 32599
• Manufacturer Contact: michelleann garcia ; 31 technology dr; irvine, CA 92618 ; 6465917981
• MDR Report Key: 14149762
• MDR Text Key: 292700946
• Report Number: 2029046-2022-00850
• Device Sequence Number: 1
• Product Code: LPB
• Combination Product (y/n): N
• Reporter Country Code: FR
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Literature,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 04/19/2022

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 Catalogue Number: UNK_THERMOCOOL SF NAV
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/25/2022
• Initial Date FDA Received: 04/19/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: ABLATION CATHETER TACTICATH, ABBOTTTECHNOLOGIES; CARTO; PENTARAY MAPPING CATHETER
• Patient Outcome(s): Other