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 Problem Pseudoaneurysm (2605)

Event Date 12/31/2014

Event Type  Injury  

Manufacturer Narrative

Manufacturer's ref.No: (b)(4).Since no device has been received for analysis, no product investigation can be performed, and the customer complaint cannot be confirmed.Manufacturer record evaluation cannot be conducted because the no 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.If additional information is received regarding this event, a supplemental 3500a report will be submitted to the fda.Biosense webster manufacturer's report number: 2029046-2021-00487 is related to the same incident.

Event Description

This complaint is from a literature source.The following complication was reported in this publication: it was reported that 1 patient underwent catheter ablation of atrial fibrillation and suffered a pseudoaneurysm in the groin, this event required ultrasound guided compression which prolonged the hospital stay one day.Model and catalog number are not available, but the suspected device is smarttouchtm thermocool.Other biosense webster devices that were also used in this study: lasso, carto 3 non-biosense webster devices that were also used in this study: prucka cardiolabtm, ep shuttle st-3077.Publication details: title: repeat pulmonary vein isolation in patients with atrial fibrillation: low ablation index is associated with increased risk of recurrent arrhythmia.Objective: we aimed to investigate the predictors of recurrent arrhythmia after repeated pulmonary vein isolation (pvi) performed in the era of contact force without additional substrate ablation.One of the predictors studied, ablation index (ai), incorporates power, contact force, and time in a weighted formula and is reported to predict lesion size in animals.Methods: consecutive patients (n ¼ 108) undergoing repeat pvi without additional substrate modification using a contact force sensing catheter were included retrospectively at a tertiary center.All ablation points were analyzed offline.A new variable, normalized ai (ai corrected for the location of the lesion¿anterior vs.Posterior) was calculated.The patients were systematically followed with clinical visit and 12-lead ecg as well as review of the regional electronic patient files at 3 and 12 months after the procedure with 5-day holter at 12 months.

• Brand Name: UNK_SMART TOUCH BIDIRECTIONAL
• Type of Device: SIMILAR DEVICE D132701, PMA # P030031/S053
• Manufacturer (Section D): BIOSENSE WEBSTER INC; 33 technology drive; 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: 11606473
• MDR Text Key: 243528938
• Report Number: 2029046-2021-00486
• Device Sequence Number: 1
• Product Code: OAD
• Combination Product (y/n): N
• Reporter Country Code: DA
• PMA/PMN Number: P030031/S053
• 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: 03/23/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/01/2021
• 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: 03/23/2021
• 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: Unknown
• Patient Sequence Number: 1
• Treatment: EP SHUTTLE ST-3077; PRUCKA CARDIOLABTM; UNK_CARTO 3; UNK_LASSO
• Patient Outcome(s): Hospitalization
• Patient Age: 60 YR