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

Model Number D132705

Device Problem Excessive Heating (4030)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 08/03/2020

Event Type  malfunction  

Manufacturer Narrative

Device evaluation details: the product was returned to biosense webster for evaluation.Bwi conducted a visual inspection and a generator compatibility evaluation of the returned device.Visual analysis of the returned sample revealed that no damage or anomalies were observed on the smart touch catheter.The catheter was connected to generator and the temperature of the catheter was measured.No temperature issues were observed.As part of bwi¿s quality process all devices are manufactured, inspected, and released to approved specifications.The event described could not be confirmed since the catheter performed without any temperature issues.Although no product defect was identified, there may have been other circumstances or issues that occurred during the use of the device that could not be replicated during the analysis.As such, biosense webster manufacturer's reference number (b)(4) has two reports: mfr # 2029046-2020-01133 for product code d132705 (thermocool® smart touch¿ bi-directional navigation catheter).Mfr # 2029046-2021-00377 for product code d132705 (thermocool® smart touch¿ bi-directional navigation catheter).

Event Description

It was reported that a patient underwent an atrial fibrillation (afib) ablation procedure with two (2) thermocool® smart touch¿ bi-directional navigation catheter wherein a procedure cancellation occurred increasing risk to patient.It was reported that during the procedure, the thermocool® smart touch¿ bi-directional navigation catheter where handle was overheating.The catheter was replaced with a 2nd thermocool® smart touch¿ bi-directional navigation catheter from the same lot # and the issue reoccurred.The procedure had to be cancelled.Patient was under general anesthesia and transseptal puncture was performed prior to case cancellation.There was no report of patient consequence.Patient did not require extended hospitalization.In the physician¿s opinion, cancellation of the procedure did not contribute to a serious injury of the patient.The customer¿s issue of the handle overheating is not mdr reportable since the potential risk that it could cause or contribute to a serious injury or death to the operator or patient is remote.

• Brand Name: THERMOCOOL SMART TOUCH 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: 11510343
• MDR Text Key: 240683914
• Report Number: 2029046-2021-00377
• Device Sequence Number: 1
• Product Code: LPB
• UDI-Device Identifier: 10846835009200
• UDI-Public: 10846835009200
• Combination Product (y/n): N
• Reporter Country Code: IT
• PMA/PMN Number: P030031/S053
• 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: 02/17/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/18/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 01/10/2021
• Device Model Number: D132705
• Device Catalogue Number: D132705
• Device Lot Number: 30329824M
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/14/2021
• Date Manufacturer Received: 02/17/2021
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/11/2020
• 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
• Treatment: THMCL SMRTTCH,BI,NAV,TC,D-F,C3