MAUDE Adverse Event Report: BIOSENSE WEBSTER INC UNK_SMART TOUCH UNIDIRECTIONAL; SIMILAR DEVICE D133601, PMA # P030031/S053

Catalog Number UNK_SMART TOUCH UNIDIRECTIONAL

Device Problem Patient Device Interaction Problem (4001)

Patient Problems Hematoma (1884); Transient Ischemic Attack (2109); Pseudoaneurysm (2605)

Event Date 01/16/2021

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, "radiofrequency versus cryoballoon catheter ablation for paroxysmal atrial fibrillation: durability of pulmonary vein isolation and effect on atrial fibrillation burden: the race-af randomized controlled trial." written by ¿rensen sk, johannessen a, worck r, hansen ml, hansen j.Circ arrhythm electrophysiol.2021 may;14(5):e009573.Doi: 10.1161/circep.120.009573.Epub 2021 apr 9.Pmid: 33835823; pmcid: pmc8136462.Lot, model and catalog number are not available, but the suspected biosense device possibly associated with reported adverse events: thermocool smarttouch.Other biosense products utilized in study (rf group): carto system (mapping), lasso catheter (mapping).Non-biosense products utilized in study in conjunction with biosense: steerable sheath at the operator discretion (agilis nxt, abbott laboratories, il) non-biosense products utilized in study (cryo group): 28 mm cryoballoon catheter (arctic front advance), a 20 mm circular mapping catheter (achieve advance), and a steerable sheath (flexcath advance; all medtronic, mn).It is noted that biosense products were utilized in the radiofrequency ablation group (rf group) and non biosense was utilized in the cryo group.Also noted is article reporting patients experiencing complications at reassessment procedure and reports the same products were utilized for reassessment procedures but does not specify which study group experienced the reassessment complications.This complaint captures adverse events reported that are associated in the rf group captured in table 2 for initial ablation and the reassessment complications in table 2 caption.Exact quantities of involved products cannot be accurately determined as the article does not specify if patients experienced more than one adverse events, and does not specify which group is associated with each adverse event in the reassessment procedure.The following adverse event(s) were reported in this publication in the rf group for safety end point related to index procedure: 1 tia (article does not discuss provided intervention).1 hematoma (article does not discuss provided intervention).1 pseudoaneurysm (article does not discuss provided intervention).The following adverse event(s) were reported in this publication for reassessment procedure without specification of associated study group: 1 tamponade drained uncomplicated in the icu and without sequela.1 pseudoaneurysm (article does not discuss provided intervention).3 groin hematomas (article does not discuss provided intervention).Objective: to test the hypothesis that rf and cryo produce comparable durability of pvi and effect on af burden (% of time in af).Methods: a randomized trial including 98 patients (68% male, 61 [5567] years) with paroxysmal af assigned 1:1 to pvi by contact-force sensing, irrigated radiofrequency catheter, or second-generation cryoballoon catheter.Implantable cardiac monitors were inserted =1 month before pvi for assessment of af burden and recurrence, and all patients, irrespective of af recurrence, underwent a second procedure 4 to 6 months after pvi to determine pvi durability.The primary end point of this randomized comparison of 2 af ablation methods was the number of durably isolated pvs at the reassessment 4 to 6 months after pvi.

• Brand Name: UNK_SMART TOUCH UNIDIRECTIONAL
• 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: gabriel alfageme ; 31 technology drive; irvine, CA 92618 ; 949789-868
• MDR Report Key: 12372561
• MDR Text Key: 268430509
• Report Number: 2029046-2021-01401
• 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,health professional,l
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 08/03/2021

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 UNIDIRECTIONAL
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/03/2021
• 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): Required Intervention