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

Model Number D134805

Device Problems Failure to Deliver Energy (1211); Patient Device Interaction Problem (4001)

Patient Problem Cardiac Tamponade (2226)

Event Date 01/21/2021

Event Type  Injury  

Manufacturer Narrative

Initial reporter phone: (b)(6).The device has been reported as discarded, therefore no product investigation can be performed, and the customer complaint cannot be confirmed.A manufacturing record evaluation was performed for the finished device 30441658m number, and no internal action related to the complaint was found during the review.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)-year-old female patient ( (b)(6) kg) underwent an atrial fibrillation (afib) ablation procedure with a thermocool® smart touch® sf bi-directional navigation catheter and suffered cardiac tamponade requiring pericardiocentesis.During the ablation phase the cardiac shadow became immobile, the physician checked for cardiac tamponade and confirmed it.Pericardiocentesis was done.Patient¿s blood pressure returned to normal after pericardial drainage.The drained fluid was venous blood.Patient had fully recovered.There¿s no report of prolonged hospitalization.The physician commented that there is no causal relationship with the ablation catheter.The cause of the tamponade still unknown, physician is unclear on if it had occur when the rv catheter was brought to the right atrium or if it scratched with the sl sheath (non-bwi product) containing the lasso when mapping the right ventricle (rv).The soundstar catheter was not in the left atrium.There was no evidence of steam pop nor other bwi product malfunction during the ablation nor throughout the case.With the information available, this event is being conservatively coded and reported under the bwi ablation catheter (ip-01066385) since the adverse event was discovered after radiofrequency therapy had been already applied; therefore, the stsf catheter cannot be excluded.Since the event is life threatening and required intervention to prevent permanent impairment of a body function or permanent damage to a body structure, 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: 11341538
• MDR Text Key: 232792255
• Report Number: 2029046-2021-00197
• Device Sequence Number: 1
• Product Code: LPB
• UDI-Device Identifier: 10846835010183
• UDI-Public: 10846835010183
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: P030031
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 01/21/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/18/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 09/20/2021
• Device Model Number: D134805
• Device Catalogue Number: D134805
• Device Lot Number: 30441658M
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 01/21/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/21/2020
• 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): Life Threatening; Required Intervention
• Patient Age: 70 YR
• Patient Weight: 60