MAUDE Adverse Event Report: BIOSENSE WEBSTER INC THERMOCOOL® SMART TOUCH¿ ELECTROPHYSIOLOGY CATHETER; SIMILAR DEVICE D133601, PMA # P030031/S053

Catalog Number UNK_SMART TOUCH UNIDIRECT

Device Problem Patient Device Interaction Problem (4001)

Patient Problems Cardiac Tamponade (2226); Pericarditis (4448)

Event Date 01/25/2022

Event Type  Injury  

Event Description

This complaint is from a literature source.Literature citation: karkowski g, kuniewicz m, zabek a, kozluk e, debski m, matusik pt, lelakowski j.Contact force-sensing versus standard catheters in non-fluoroscopic radiofrequency catheter ablation of idiopathic outflow tract ventricular arrhythmias.J clin med.2022 jan 25;11(3):593.Doi: 10.3390/jcm11030593.Pmid: 35160043; pmcid: pmc8836481.Objective/methods/study data: authors aim d to evaluate the potential benefits of open irrigated cfs catheters in rfca of idiopathic vas from ots without fluoroscopy guidance.Authors retrospectively analyzed a group of 102 patients who between 2014 and 2018 underwent nf-rfca of premature ventricular contractions (pvc) from ots.Lot, model and catalog number are not available, but the suspected biosense device possibly associated with reported adverse events: 3.5 mm open irrigated navistar thermocool in the standard group and thermocool smarttouch in the remainder concomitant other biosense webster devices that were also used in this study: carto3 non-biosense webster devices that were also used in this study: n/a.Adverse event(s) and provided interventions possibly associated with ablation catheter: qty 2 pericarditis in cfs group (one treated with pharmacotherapy and the other required pericardiocentesis as the patient developed pericardial effusion).

Manufacturer Narrative

This complaint is from a literature source.Literature citation: karkowski g, kuniewicz m, zabek a, kozluk e, debski m, matusik pt, lelakowski j.Contact force-sensing versus standard catheters in non-fluoroscopic radiofrequency catheter ablation of idiopathic outflow tract ventricular arrhythmias.J clin med.2022 jan 25;11(3):593.Doi: 10.3390/jcm11030593.Pmid: 35160043; pmcid: pmc8836481.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 not provided by the customer.Manufacturer's reference number: (b)(4).

• Brand Name: THERMOCOOL® SMART TOUCH¿ ELECTROPHYSIOLOGY CATHETER
• Type of Device: SIMILAR DEVICE D133601, PMA # P030031/S053
• 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 ; 646591-798
• MDR Report Key: 14726306
• MDR Text Key: 294280266
• Report Number: 2029046-2022-01354
• Device Sequence Number: 1
• Product Code: LPB
• Combination Product (y/n): N
• Reporter Country Code: PL
• PMA/PMN Number: P030031/S053
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Literature,Health Professional
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 06/16/2022

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_SMART TOUCH UNIDIRECT
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 05/20/2022
• Initial Date FDA Received: 06/17/2022
• 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: UNK_CARTO 3
• Patient Outcome(s): Life Threatening; Required Intervention