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 Laceration(s) of Esophagus (2398)

Event Date 03/31/2020

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 numbers: 2029046-2021-00556 and 2029046-2021-00557 are 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 3 patients underwent catheter ablation of atrial fibrillation with standard temperature monitoring (control group) and suffered severe grade 3 thermal injury of endoscopically detected esophageal thermal lesions (edels).Intervention was not reported.Endoscopy findings were classified as 1, erythemamild injury; 2, superficial ulcerationmoderate injury; 3, deep ulcerationsignificant injury; and 4, fistula/perforation.Severe edels were defined as grade 3 or 4 lesions.All patients with edels remained asymptomatic, and there were no atrio-esophageal fistula or perforation during follow-up.Model and catalog number are not available, but the suspected device is unk_smart touch bidirectional other biosense webster devices that were also used in this study: carto non-biosense webster devices that were also used in this study: ensoetm device, gaymar medi-therm iii publication details: title: active esophageal cooling for the prevention of thermal injury during atrial fibrillation ablation: a randomized controlled pilot study objective: we sought to evaluate safety and feasibility of active esophageal cooling using the attune medical esophageal heat transfer device (ensoetm) to limit frequency or severity of edels.Methods: consecutive patients undergoing first-time rfca were randomized in a 1:1 fashion to esophageal cooling (device group) or standard temperature monitoring (control group).Ablation on the posterior wall was performed with a maximum power of 30w for up to 20s.All patients underwent egd within 48 h.Endoscopy findings were classified as 1, erythemamild injury; 2, superficial ulcerationmoderate injury; 3, deep ulcerationsignificant injury; and 4, fistula/perforation.Severe edels were defined as grade 3 or 4 lesions.

• 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: 11645894
• MDR Text Key: 245338226
• Report Number: 2029046-2021-00555
• Device Sequence Number: 1
• Product Code: LPB
• Combination Product (y/n): N
• Reporter Country Code: US
• 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: 03/25/2021

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: 03/25/2021
• Initial Date FDA Received: 04/09/2021
• 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: 63 YR