MAUDE Adverse Event Report: BIOSENSE WEBSTER INC UNK_SMART TOUCH BIDIRECTIONAL; SIMILAR DEVICE D132701, PMA # P030031/S053

Catalog Number UNK_SMART TOUCH BIDIRECTIONAL

Device Problem Patient Device Interaction Problem (4001)

Patient Problems Hemorrhage/Bleeding (1888); Cardiac Tamponade (2226); Pericarditis (4448)

Event Date 07/21/2021

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.If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.

Event Description

This complaint is from a literature source.The literature article titled, ""wenckebach cycle length: a novel predictor for av block in avnrt patients treated with ablation"" written by lisette i.S.Wintgens, martijn n.Klaver, moniek maarse, stefan g.Spitzer, anke langbein, martin j.Swaans, vincent f.Van dijk, jippe c.Balt, maurits c.E.F.Wijffels, jan g.P.Tijssen, arif elvan, and lucas v.A.Boersma published by european society of cardiology 2021 jul 19;euab168.Doi: 10.1093/europace/euab168 pmid: pmid: 34279627 was reviewed.Model and catalog number are not available, but the suspected biosense device possibly associated with reported adverse events: smarttouch catheter.Other biosense products utilized in study: carto mapping system non-biosense products utilized in study: tacticath (abbott).Exact quantities of involved products cannot be accurately determined as the article does not specify which specific ablation catheters are associated with each adverse event.The following adverse event(s) were reported in this publication in table 3 captured under contact force: one tamponade (article does not discuss intervention provided), two pericarditis (article does not discuss intervention provided), two minor access site bleeding (article does not discuss intervention provided).Objective: a comparison study between pvac gold catheter or st-cf irf ablation with 3d mapping.Methods: pvac gold ablation was performed using the pvac gold catheter (medtronic, minneapolis, mn, usa) and the genius rf generator (genius contact iq, medtronic, minneapolis, mn, usa).For st-cf either smarttouch (biosense webster inc., ca, usa) or tacticath (abbott, usa) ablation catheters were allowed.3d navigation was performed with either biosense webster¿svr carto or abbott¿stm ensite velocity (navx).A total of 208 patients (105 vs.103) were included in the safety analysis and 206 patients (103 vs.103) in the efficacy analysis.

• Brand Name: UNK_SMART TOUCH BIDIRECTIONAL
• Type of Device: SIMILAR DEVICE D132701, 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: gabriel alfageme ; 31 technology drive; irvine, CA 92618 ; 949789-868
• MDR Report Key: 12372467
• MDR Text Key: 268435289
• Report Number: 2029046-2021-01398
• Device Sequence Number: 1
• Product Code: LPB
• Combination Product (y/n): N
• Reporter Country Code: NL
• PMA/PMN Number: P030031/S053
• 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: 08/16/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/26/2021
• 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: 08/16/2021
• 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