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

Catalog Number D133604IL

Device Problems Material Puncture/Hole (1504); Contamination /Decontamination Problem (2895)

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

Event Date 05/25/2023

Event Type  malfunction  

Manufacturer Narrative

The product investigation was completed.Device evaluation details: a picture was received for evaluation following biosense webster's procedures.According to pictures provided by the customer, reddish material (presumably blood) was observed inside the pebax; however, no external damages were observed on the device.The device was returned to biosense webster (bwi) for evaluation.A visual inspection of the returned device was performed in accordance with bwi procedures.Visual analysis revealed reddish material inside the pebax and electrode damage (bent).The tip of the device was microscopically inspected, it was observed that an electrode was bent, furthermore, the bent electrode caused the pebax to be displaced which may have formed an opening between these two components that allowed reddish material from the procedure to enter the pebax area.Additionally, reddish material was observed stuck inside the irrigation holes of the device.It was determined that the bent electrode, displaced pebax and obstructed irrigation holes issues found during the investigation may be related to the procedure; however, this could not be conclusively determined.A manufacturing record evaluation was performed for the finished device 30990601m, and no internal action was found during the review.The pebax issue reported by the customer was confirmed.It should be noted that product failure is multifactorial.As part of biosense webster's quality process, all devices are manufactured, inspected, and released to approved specifications.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 and post procedure the bwi product analysis lab identified reddish material inside the pebax (a hole) and a displaced pebax.During the procedure, the tip of the device was found damaged (no exposed wires as the photo shows) after the ablation stopped.The ablation just lasted for about 5 seconds in the patient¿s body.A second device was used to complete the operation.There was no adverse event reported on patient.The damaged tip mid-procedure is not mdr-reportable.The hole in the pebax + displaced pebax 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: 17495101
• MDR Text Key: 320759961
• Report Number: 2029046-2023-01734
• Device Sequence Number: 1
• Product Code: LPB
• Combination Product (y/n): N
• Reporter Country Code: CH
• 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: 08/09/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/09/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 02/09/2024
• Device Catalogue Number: D133604IL
• Device Lot Number: 30990601M
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/06/2023
• Date Manufacturer Received: 07/13/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/10/2023
• 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