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

Catalog Number UNK_SMART TOUCH BIDIRECTIONAL

Device Problem Patient Device Interaction Problem (4001)

Patient Problems Cardiac Tamponade (2226); Insufficient Information (4580)

Event Date 04/05/2023

Event Type  Injury  

Event Description

This complaint is from a literature source.The following literature cite has been reviewed: di c, wang q, wu y, li l, lin w.Monitoring spike potential and abrupt impedance rise with concomitant temperature/contact force change for timely detection of the occurrence of "silent" or "nonaudible" steam pop.J interv cardiol.2023 apr 5;2023:8873404.Doi: 10.1155/2023/8873404.Pmid: 37064642; pmcid: pmc10098411.Objective/methods/study data:tis study sought to assess the feasibility of monitoring the recorded spike potential and abrupt rise in impedance with concomitant temperature and/or cf change as an indicator fortimely detection of the occurrence of ¿silent¿ or ¿nonaudible¿ sp events, particularly in regions where the risk of perforation may be of concern.Lot, model and catalog number are not available, but the suspected biosense device possibly associated with reported adverse events: 3.5 mm externally irrigated-tip ablation catheter (smarttouch, d curve or f curve, biosense webster, diamond bar, ca, usa) other biosense webster devices that were also used in this study: decapolar mapping catheter (lasso, biosense webster, diamond bar, ca, usa), steerable sheath (mobicath, biosense webster, diamond bar, ca, usa) was advanced alternately only when the nonsteerable sheath could not advance the non-biosense webster devices that were also used in this study: nonsteerable sheath (8.5 f sl1, st.Jude medical, st.Paul, mn, usa) could not advance the adverse event(s) and provided interventions: 15 reported steam pops.2 patients developed pericardial tamponade and underwent drainage.

Manufacturer Narrative

This complaint is from a literature source.The following literature cite has been reviewed: di c, wang q, wu y, li l, lin w.Monitoring spike potential and abrupt impedance rise with concomitant temperature/contact force change for timely detection of the occurrence of "silent" or "nonaudible" steam pop.J interv cardiol.2023 apr 5;2023:8873404.Doi: 10.1155/2023/8873404.Pmid: 37064642; pmcid: pmc10098411.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.This report is being submitted pursuant to the provisions of 21 cfr, part 4.This report may be based on information which has not been investigated or verified prior to the required reporting date.This report does not reflect a conclusion by biosense webster inc, or its employees that the report constitutes an admission that the product, biosense webster inc, or its employees caused or contributed to the potential event described in this report.If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.Manufacturer¿s reference number: (b)(4).

• Brand Name: UNK_SMART TOUCH BIDIRECTIONAL
• 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: kate karberg ; 31 technology dr; irvine, CA 92618 ; 3035526892
• MDR Report Key: 17163978
• MDR Text Key: 317540082
• Report Number: 2029046-2023-01318
• Device Sequence Number: 1
• Product Code: LPB
• Combination Product (y/n): N
• Reporter Country Code: CH
• PMA/PMN Number: P030031/S053
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Study,Literature,Health Professional
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 06/20/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/20/2023
• 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: 05/23/2023
• 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
• Treatment: DECAPOLAR MAPPING CATHETER.; NONSTEERABLE SHEATH (8.5 F SL1, ST. JUDE MEDICAL.; STEERABLE SHEATH (MOBICATH).
• Patient Outcome(s): Life Threatening