MAUDE Adverse Event Report: BIOSENSE WEBSTER INC THERMOCOOL® SMART TOUCH¿ ELECTROPHYSIOLOGY CATHETER; SIMILAR DEVICE D133601, PMA # P030031/S053

Catalog Number UNK_SMART TOUCH UNIDIRECTIONAL

Device Problem Patient Device Interaction Problem (4001)

Patient Problems Low Blood Pressure/ Hypotension (1914); Heart Block (4444); Heart Failure/Congestive Heart Failure (4446); Pericarditis (4448)

Event Date 07/01/2021

Event Type  Injury  

Manufacturer Narrative

Manufacturer's ref.No: (b)(4).This complaint is from a literature source.The following literature citation has been reviewed: li shixing,shi xiangmin,li jian,shan zhaoliang,guo hongyang, yuan hongtao,lin kun,guo jianping,wang yutang.Experience with radiofrequency catheter ablation of elderly af patients in a single center.Chinese published article.Doi and publisher is unknown.Exact date of event is not available as such, the date of (b)(6) 2021 was populated.Date of event which is the month and year of the article publication.Since no device has been received for analysis, no product investigation can be performed, and the customer complaint cannot be confirmed.Manufacturing record evaluation (mre) cannot be conducted because no lot number was not provided by the customer.

Event Description

This complaint is from a literature source.The following literature citation has been reviewed: li shixing,shi xiangmin,li jian,shan zhaoliang,guo hongyang, yuan hongtao,lin kun,guo jianping,wang yutang.Experience with radiofrequency catheter ablation of elderly af patients in a single center.Chinese published article.Doi and publisher is unknown.Objective/methods/study data: to summarize the experience with radiofrequeney catheter ablation of elderly af patients in a single center.One hundred and twenty¿two elderly af patients who underwent radiofrequency catheter ablation in our center from january 20 1 8 to september 20 1 9 were included in this study.1 study subjects 122 elderly patients with atrial fibrillation who received radiofrequency catheter ablation in chinese pla general hospital from january 2018 to june 2019, 81 males (66.4%) and 41 females, aged 60 to 84 (67.0 ± 5.1) years, including 72 cases of hypertension (59.0%), 45 cases of coronary heart disease (36.9%), 10 cases of cardiac insufficiency (8.2%), 30 cases of cerebrovascular disease history (24.6%), 25 cases of diabetes (20.5%), 18 cases of renal insufficiency (14.8%), 41 cases of smoking history (33.6%), 38 cases of drinking history (31.1%), 39 cases of persistent atrial fibrillation (32.0%), 83 cases of paroxysmal atrial fibrillation (68.0%), duration of atrial fibrillation (42.1 ± 54.3) months.Lot, model and catalog number are not available, but the suspected biosense device possibly associated with reported adverse events: smarttouch ablation catheter other biosense webster devices that were also used in this study: pentaray mapping catheter, carto 3 non-biosense webster devices that were also used in this study: n/a.Adverse event(s) and provided interventions (associated with ablation): qty 1 post-myocardial injury syndrome - no further information provided on specific injury; no information provided regarding intervention.Qty 1 atrial stiffness syndrome - no further information provided on specific injury; no information provided regarding intervention.Qty 2 intra-artrial block namely bayesian syndrome - no further information provided on specific injury; no information provided regarding intervention.Qty 4 hypotension - no information provided regarding intervention.

• Brand Name: THERMOCOOL® SMART TOUCH¿ ELECTROPHYSIOLOGY CATHETER
• 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: michelleann garcia ; 31 technology dr; irvine, CA 92618 ; 646591-798
• MDR Report Key: 15246728
• MDR Text Key: 298114475
• Report Number: 2029046-2022-01904
• Device Sequence Number: 1
• Product Code: LPB
• Combination Product (y/n): N
• Reporter Country Code: CH
• PMA/PMN Number: P030031/S053
• 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: 08/17/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/17/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: UNK_SMART TOUCH UNIDIRECTIONAL
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 07/19/2022
• 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: CARTO 3; PENTARAY MAPPING CATHETER
• Patient Outcome(s): Life Threatening