MAUDE Adverse Event Report: BIOSENSE WEBSTER INC THERMOCOOL® SMART TOUCH¿ ELECTROPHYSIOLOGY CATHETER; CARDIAC ABLATION PERCUTANEOUS CATHETER

Catalog Number D133605IL

Device Problems Crack (1135); Manufacturing, Packaging or Shipping Problem (2975)

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

Event Date 07/25/2023

Event Type  malfunction  

Manufacturer Narrative

The bwi product analysis lab received a video for evaluation.Device investigation details: a video was received for evaluation following biosense webster's procedures.According to video provided by the customer, the pebax was observed with broken with a piece sticking out.A manufacturing record evaluation was performed for the finished device 31001842m number, and no internal action related to the complaint was found during the review.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) ablation procedure with a thermocool® smart touch¿ electrophysiology catheter in which device damage occurred.Before the operation, the tip of the device had been found damaged when the package was opened--the outer box/packaging was not damaged.It seemed like the outer layer of the device was broken and detached.The catheter pebax itself was not damaged.A second device was used to complete the operation.There was no adverse event reported on patient.The reported device wasn't used on the patient.The broken/detached component on the catheter tip is mdr-reportable.

• Brand Name: THERMOCOOL® SMART TOUCH¿ ELECTROPHYSIOLOGY CATHETER
• Type of Device: CARDIAC ABLATION PERCUTANEOUS CATHETER
• Manufacturer (Section D): BIOSENSE WEBSTER INC; 31 technology drive, suite 200; irvine CA 92618
• Manufacturer (Section G): BIOSENSE WEBSTER INC (JUAREZ); circuito interior norte; 1820parque industrial salvacar; juarez 32599 ; MX 32599
• Manufacturer Contact: kate karberg ; 31 technology dr; irvine, CA 92618 ; 3035526892
• MDR Report Key: 17592645
• MDR Text Key: 321839581
• Report Number: 2029046-2023-01822
• Device Sequence Number: 1
• Product Code: LPB
• Combination Product (y/n): N
• Reporter Country Code: CH
• PMA/PMN Number: P030031/S053
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 08/21/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/21/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 03/23/2024
• Device Catalogue Number: D133605IL
• Device Lot Number: 31001842M
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 07/26/2023
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 03/24/2023
• 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: SYNAPTIC S0856332L1/N18710E