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

Catalog Number UNK_SMART TOUCH BIDIRECTIONAL

Device Problem Patient Device Interaction Problem (4001)

Patient Problem Paralysis (1997)

Event Date 08/31/2020

Event Type  Injury  

Manufacturer Narrative

Manufacturer's ref.No : (b)(4).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.Device history record (dhr) review cannot be conducted because the lot number was provided by the customer.Manufacturer's report number: 2029046-2021-01232 is related to the same incident.

Event Description

This complaint is from a literature source.The following complications were reported in this publication: two groups were involved in this study.A total of 100 patients underwent an index superior vena cana isolation (svci) using high power, short duration (hpsd) ablation or conventional lower power and longer duration (lpld group) ablation, using the thermocool smarttouch sf.It was reported that 1 patient underwent superior vena cava isolation (svci) ablation in the hpsd group suffered right phrenic nerve injury.Intervention was not reported.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 the patients.No other complications related to the svc ablation, including sinus node injury or steam pops, were observed in any patients.Model and catalog number are not available, but the suspected device is thermocool smarttouch sf other biosense webster devices that were also used in this study: lasso , visitag.Non-biosense webster devices that were also used in this study: none.Publication details: title: superior vena cava isolation with 50 w high power, shortduration ablation strategy.Objective: the optimal ablation strategy is unkn own regard ing a super ior vena cavaisolation (svci).This study a imed to examine the feasibility and safety and to analyze thelesion characteristics of the svci using high power, short duration (hpsd) ablation.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.

• Brand Name: UNK_SMART TOUCH BIDIRECTIONAL SF
• Type of Device: UNK
• 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: 12259880
• MDR Text Key: 264711914
• Report Number: 2029046-2021-01231
• 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,literature
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 07/13/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/02/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: UNK_SMART TOUCH BIDIRECTIONAL
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 07/13/2021
• 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
• Patient Age: 64 YR