MAUDE Adverse Event Report: BIOSENSE WEBSTER INC UNK_SMART TOUCH BIDIRECTIONAL SF; CARDIAC CATHETER

Catalog Number UNK_SMART TOUCH BIDIRECTIONAL

Device Problem Patient Device Interaction Problem (4001)

Patient Problem Paralysis (1997)

Event Date 04/19/2021

Event Type  Injury  

Manufacturer Narrative

Manufacturer's ref.No: (b)(4).Investigation summary: since the product has not been returned, no corrective action is warranted at this time.As a result, we are closing this investigation.If the complaint device is received in the future, we will reopen the complaint and perform the investigation as appropriate.Device history record (dhr) review cannot be conducted because the lot number was provided by the customer.

Event Description

This complaint is from a literature source.The following literature cite has been reviewed kusa s, hachiya h, sato y, hara s, ohya h, miwa n, yamao k, iesaka y, sasano t."superior vena cava isolation with 50¿w high power, short duration ablation strategy." j cardiovasc electrophysiol.2021 jun;32(6):1602-1609.Doi: 10.1111/jce.15060.Epub 2021 may 5.Pmid: 33949738.Objective: to evaluate the electrical svc isolation (svci) using the hpsd ablation strategy.Methods: a total of 100 patients underwent an index svci using hpsd (n = 50, hpsd group) or conventional lower-power and longer-duration (n = 50, lpld group) ablation, using the thermocool smarttouch sf.In the hpsd group, ablation was performed with a power of 50 w for 7 s, and was limited to 4 s at the lateral segment close to the right phrenic nerve.The ablation setting used in the lpld group was 2025 w for 2030 s and was limited to 1020 w for 1530 s at the lateral segment when diaphragmatic capture was seen.An electrical svci was achieved in all patients.Lot, model and catalog number are not available, but the suspected biosense device possibly associated with reported adverse events: thermocool smart touch sf ablation catheter.Other biosense webster devices that were also used in this study: lasso (diagnostic mapping), visitag (software).Non-biosense webster devices that were also used in this study: n/a.Adverse event(s) and provided interventions: right pni (phrenic nerve injury) in 1 patient during procedure and in 3 patients diagnosed by chest x-ray day after procedure.The degree of the right diaphragmatic elevation was mild, which was half of the height of one vertebra, 12 and no symptoms associated with pni were observed in all four patients (intervention not specified).

• Brand Name: UNK_SMART TOUCH BIDIRECTIONAL SF
• Type of Device: CARDIAC 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: gabriel alfageme ; 31 technology drive; irvine, CA 92618 ; 949789-868
• MDR Report Key: 12433611
• MDR Text Key: 273846796
• Report Number: 2029046-2021-01496
• Device Sequence Number: 1
• Product Code: OAD
• Combination Product (y/n): N
• Reporter Country Code: JA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,l
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 08/11/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/07/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Device Catalogue Number: UNK_SMART TOUCH BIDIRECTIONAL
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/11/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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