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 Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Transient Ischemic Attack (2109)

Event Date 11/03/2015

Event Type  Injury  

Manufacturer Narrative

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.Concomitant products that used in this study: none non-biosense webster devices that were also used in this study: sl0 sheath (st.Jude) manufacturer's ref.No: (b)(4).Biosense webster manufacturer's report numbers: 2029046-2019-02637, 2029046-2019-02638, are related to the same incident.

Event Description

This complaint is from a literature source.The following complications were reported in this publication: 1 patients underwent catheter ablation of atrial fibrillation and suffered transient "ishcemic" attack.The symptoms resolved completely at follow-up and the patient had a normal neurologic examination before and after the ablationprocedure.No further details were provided.There are 0 death events and 0 device malfunctions reported in this publication.Model and catalog number are not available, but the suspected device is smarttouch thermocool sf.Other biosense webster devices that were also used in this study: none.Non-biosense webster devices that were also used in this study: none.Publication details: title: safety and efficiency of porous-tip contact-force catheter for drug-refractory symptomatic paroxysmal atrial fibrillation ablation: results from the smart sf trial.Objective: the study examined the periprocedural safety, acute effectiveness, and procedural efficiency of the smarttouch sf catheter for drug-refractory symptomatic paroxysmal atrial fibrillation (paf) ablation.Methods: 159 patients underwent radiofrequency ablation between 30 march 2015, and 3 november 2015.

• 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 ; 33 technology drive; irvine, CA 92618 ; 949789-868
• MDR Report Key: 8297277
• MDR Text Key: 134744902
• Report Number: 2029046-2019-02639
• Device Sequence Number: 1
• Product Code: LPB
• Combination Product (y/n): N
• PMA/PMN Number: P030031/S053
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: literature
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 01/14/2019

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 BIDIRECTIONAL
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 01/14/2019
• Initial Date FDA Received: 02/01/2019
• 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: 63 YR