MAUDE Adverse Event Report: BIOSENSE WEBSTER INC THERMOCOOL SMART TOUCH SF BI-DIRECTIONAL NAVIGATION CATHETER; CARDIAC ABLATION PERCUTANEOUS CATHETER

Catalog Number UNK_SMART TOUCH BIDIRECTIONAL

Device Problem Patient Device Interaction Problem (4001)

Patient Problem Heart Block (4444)

Event Date 02/17/2021

Event Type  Injury  

Manufacturer Narrative

Additional information received indicates that the device is not available for return, therefore 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 information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.If additional information is received regarding this event, a supplemental 3500a report will be submitted to the fda.Manufacturer's reference number: (b)(4).

Event Description

It was reported that a (b)(6) old female patient ((b)(6) kg) with a history of congenital heart defect, single ventricle s/p glenn (cardiac surgery) underwent a atrioventricular reentrant tachycardia (avrt) and wolff-parkinson-white (wpw) with an unspecified thermocool® smart touch® sf bi-directional navigation catheter and experienced heart block.During the ablation when radiofrequency (rf) is on, the back patch displays a back patch detached error.Patch placement is limited based on patient size.The patches and cables seem to be isolated from each other and the indifferent electrode is on the right leg.A second indifferent electrode was added without resolution.The patches were replaced.The back- patch sensor cable was replaced, and the carto 3 system was rebooted.The caller stated that the replacement patch sensor cable was difficult to seat in the patch unit then a 1006 error displayed after the cable replacement.The original sensor cable was connected back to the piu/patch unit and the 1006 resolved.After 11 seconds of rf a small steam pop occurred then 2:1 heart block which resolved within a few minutes.A back patch 3 disconnect error was then displayed on the carto 3.The outcome of the adverse event: fully recovered no adverse events noted.Since the event is life-threatening and required intervention to prevent permanent impairment of a body function or permanent damage to a body structure, then it is to be considered serious and mdr-reportable.

• Brand Name: THERMOCOOL SMART TOUCH SF BI-DIRECTIONAL NAVIGATION CATHETER
• Type of Device: CARDIAC ABLATION PERCUTANEOUS CATHETER
• 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 dr; irvine, CA 92618 ; 9497898687
• MDR Report Key: 11449117
• MDR Text Key: 239828365
• Report Number: 2029046-2021-00327
• Device Sequence Number: 1
• Product Code: LYB
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 02/17/2021

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
• Initial Date Manufacturer Received: 02/17/2021
• Initial Date FDA Received: 03/09/2021
• Was Device Evaluated by Manufacturer?: No
• 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): Other
• Patient Age: 2 YR
• Patient Weight: 11