MAUDE Adverse Event Report: BIOSENSE WEBSTER INC UNK_SMART TOUCH BIDIRECTIONAL SF; CARDIAC ABLATION PERCUTANEOUS CATHETER

Catalog Number UNK_SMART TOUCH BIDIRECTIONAL

Device Problem Patient Device Interaction Problem (4001)

Patient Problem Stenosis (2263)

Event Date 12/31/2021

Event Type  Injury  

Manufacturer Narrative

This complaint is from a literature source.The following literature cite has been reviewed: fukudome k, suzuki t, shimeno k, yoshida y, terashi e, nakamura y.A case of pediatric atrial fibrillation ablation resulting in unilateral pulmonary vein occlusion during long-term follow-up.Heartrhythm case rep.2021 dec 31;8(3):222-226.Doi: 10.1016/j.Hrcr.2021.12.017.Pmid: 35492850; pmcid: pmc9039692.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.This report is being submitted pursuant to the provisions of 21 cfr, part 4.This report may be based on information which has not been investigated or verified prior to the required reporting date.This report does not reflect a conclusion by biosense webster inc, or its employees that the report constitutes an admission that the product, biosense webster inc, or its employees caused or contributed to the potential event described in this report.If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.Manufacturer¿s reference number: (b)(4).

Event Description

This complaint is from a literature source.The following literature cite has been reviewed: fukudome k, suzuki t, shimeno k, yoshida y, terashi e, nakamura y.A case of pediatric atrial fibrillation ablation resulting in unilateral pulmonary vein occlusion during long-term follow-up.Heartrhythm case rep.2021 dec 31;8(3):222-226.Doi: 10.1016/j.Hrcr.2021.12.017.Pmid: 35492850; pmcid: pmc9039692.Objective/methods/study data: pulmonary vein (pv) isolation is a treatment of choice for drug-resistant atrial fibrillation (af) in adult patients, and pv obstruction is one of the complications that may occur in less than 1.0% of patients.1 because af is rare in pediatric patients, there are few reports of pv isolation in children, and its complications have not been reported.Here we report a case of pv occlusion that developed as a long-term complication of pv isolation performed for paroxysmal af in an otherwise healthy pediatric patient.Lot, model and catalog number are not available, but the suspected biosense device possibly associated with reported adverse events: smarttouch surround flow catheters (biosense-webster, irvine, ca).Other biosense webster devices that were also used in this study: n/a non-biosense webster devices that were also used in this study: 8.5f long sheath (agilis; abbott, chicago, il).Sl1; abbott.Inquiry optima; st.Jude medical, saint paul, mn.Adverse event(s) and provided interventions: a 10-year-old boy (height 136.0 cm, weight 37.3 kg, body mass index [bmi] 20.2) suffered pulmonary vein occlusion ( pulmonary vein stenosis) post cardiac ablation requiring cardiac catheterization.Given the resolution of the clinical symptoms and the absence of pulmonary hypertension at rest, close monitoring of the patient was continued without any intervention or medication.At the time of this report ( 2 years and 9 months after ablation), the patient is on mild exercise restriction and free from clinical symptoms, such as blood sputum and pulmonary hypertension at rest, or recurrence of af.

• Brand Name: UNK_SMART TOUCH BIDIRECTIONAL SF
• Type of Device: CARDIAC ABLATION PERCUTANEOUS CATHETER
• 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: michelleann garcia ; 31 technology dr; irvine, CA 92618 ; 646591-798
• MDR Report Key: 15254727
• MDR Text Key: 298199612
• Report Number: 2029046-2022-01912
• Device Sequence Number: 1
• Product Code: LPB
• Combination Product (y/n): N
• Reporter Country Code: JA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Literature,Health Professional
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 08/18/2022

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: 08/03/2022
• Initial Date FDA Received: 08/18/2022
• 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
• Treatment: 8.5F LONG SHEATH (AGILIS, ABBOTT, CHICAGO, IL); INQUIRY OPTIMA, ST. JUDE MEDICAL, SAINT PAUL, MN; SL1, ABBOTT
• Patient Outcome(s): Life Threatening; Hospitalization; Required Intervention