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

Catalog Number D133604IL

Device Problem Electrical /Electronic Property Problem (1198)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 09/08/2020

Event Type  malfunction  

Manufacturer Narrative

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 patient underwent an atrial fibrillation (afib) cardiac ablation procedure with a thermocool® smart touch¿ electrophysiology catheter where debilitating noise on all electrocardiogram (ecg) channels occurred.It was reported that during the af operation, the signal interference (noise/loss) was observed on all intracardiac (ic) and body surface (bs) channels.A second catheter was used to complete the operation.There was no adverse event reported on the patient.There was no recording system available--only carto was used.There was no external signal such as defibrillator or anesthesia monitor available.During the signal interference/loss, the affected catheter was inside the patient¿s body.The debilitating noise on all ecg channels is an mdr-reportable event.

Manufacturer Narrative

The bwi product analysis lab received the device for evaluation.The analysis has begun but is not completed at this time.When the investigational analysis has been completed, a supplemental 3500a report will be submitted.If additional information is received regarding this event, a supplemental 3500a report will be submitted to the fda.Manufacturer's reference number: (b)(4).

Manufacturer Narrative

On (b)(6) 2020, the product investigation was completed.It was reported that a patient underwent an atrial fibrillation (afib) cardiac ablation procedure with a thermocool® smart touch¿ electrophysiology catheter where debilitating noise on all electrocardiiogram (ecg) channels occurred.It was reported that during the af operation, the signal interference (noise/loss) was observed on all intracardiac (ic) and body surface (bs) channels.A second catheter was used to complete the operation.There was no adverse event reported on the patient.Device evaluation details: the device was visually inspected, and it was found in good conditions.Then, electrical test was performed, and the catheter failed, no electrical readings were observed on electrode #02.A failure analysis was performed, and the catheter was dissected on the tip area, the electrical wires were found broken from cut to pins causing the improper electrical signal.A manufacturing record evaluation was performed and no internal action was found during the review.The customer complaint was confirmed.The root cause of the electrical wire breakage cannot be determined.If additional information is received regarding this event, a supplemental 3500a report will be submitted to the fda.Manufacturer's reference number: (b)(4).

• Brand Name: THERMOCOOL SMART TOUCH ELECTROPHYSIOLOGY CATHETER
• Type of Device: SIMILAR DEVICE D133601, PMA # P030031/S053
• Manufacturer (Section D): BIOSENSE WEBSTER INC; 33 technology drive; irvine CA 92618
• MDR Report Key: 10607650
• MDR Text Key: 225129897
• Report Number: 2029046-2020-01357
• Device Sequence Number: 1
• Product Code: LYB
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional
• Type of Report: Initial,Followup,Followup
• Report Date: 09/08/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/30/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 02/13/2021
• Device Catalogue Number: D133604IL
• Device Lot Number: 30345507M
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/08/2020
• Date Manufacturer Received: 10/23/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: CARTO SYSTEM