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 Paralysis (1997)

Event Date 01/31/2013

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 additional information is received regarding this event, a supplemental 3500a report will be submitted to the fda.Biosense webster manufacturer's report number: 2029046-2021-00559 is related to the same incident.

Event Description

This complaint is from a literature source.The following complications were reported in this publication: it was reported that 2 patients underwent catheter ablation of atrial fibrillation and suffered transient phrenic palsy with complete resolution before the end of the procedure.Model and catalog number are not available, but the suspected device is thermocool, smarttouch other biosense webster devices that were also used in this study: pentaray, carto 3 non-biosense webster devices that were also used in this study: flexcath advance, achieve, arctic front advance publication details title: single procedural outcomes in the setting of percutaneous ablation for persistent atrial fibrillation: a propensity-matched score comparison between different strategies objective: catheter ablation for persistent atrial fibrillation (persaf) is associated with less favorable outcomes than for paroxysmal af.To improve success rates, left atrial (la) substrate modification is frequently performed in addition to pulmonary vein isolation (pvi).The purpose of the study was to compare 4 different ablation approaches using radiofrequency catheter ablation (rfca) or cryoballoon ablation (cb-a) for persaf and to evaluate the respective outcomes on a midterm follow-up of 12 months methods: we did a propensity score¿matched comparison of 30 patients undergoing pvi + la posterior wall isolation (lapwi) with cb-a, 30 patients who underwent pvi + linear ablation (roof and mitral lines) using rfca, 60 patients with pvi alone using cb-a, and 60 patients who had pvi alone using rfca.The endpoint was recurrence of documented atrial tachyarrhythmias (atas) > 30 s at 1-year follow-up.".

• 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: 11645982
• MDR Text Key: 246285280
• Report Number: 2029046-2021-00560
• Device Sequence Number: 1
• Product Code: OAD
• Combination Product (y/n): N
• Reporter Country Code: BE
• 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: 03/26/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/09/2021
• 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: 03/26/2021
• 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
• Patient Outcome(s): Other
• Patient Age: 57 YR