MAUDE Adverse Event Report: BIOSENSE WEBSTER INC CELSIUS¿ ELECTROPHYSIOLOGY CATHETER; ELECTRODE, PERCUTANEOUS, CONDUCTION TISSUE ABLATION

Catalog Number D7TBL252RT

Device Problem Break (1069)

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

Event Date 09/14/2023

Event Type  malfunction  

Event Description

It was reported that a patient underwent an atrial tachycardia right (r-at) procedure with a celsius¿ electrophysiology catheter and a wires exposed issue occurred.The physician unpacked the product to use in the procedure.Then he found that the tip of the catheter had more curliness than usual.Therefore, the physician had a concern about safety of the patient.They sent back the product to the company for investigation.They could not find in the catalog the detail about the curve degree of catheter tip before nod adjust.There was no patient consequence.Additional information was received on 09-oct-2023.This complaint was found before the procedure at opening.The product had not been used.Additional information was received on 16-nov-2023.The damage resulted in wires being exposed.User inspected by eye before insertion.Curve was weird more than as usual and physician concerned if catheter was to be inserted into the heart.Or with the curve like this during ablation, curve will not be stable and it might touch the atrioventricular (av) node.This event was originally considered non-reportable, however, bwi became aware that wires were exposed on 16-nov-2023 and have reassessed the event as reportable.

Manufacturer Narrative

E1.Initial reporter phone: (b)(6).The bwi product analysis lab received the device for evaluation on 26-oct-2023.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.This report is being submitted pursuant to the provisions of 21 cfr, part 803.This report may be based on information which has not been investigated or verified prior to the required reporting date.This report does not reflect a conclusion by biosense webster, inc., or its employees that the report constitutes an admission that the product, biosense webster, inc., or its employees caused or contributed to the potential event described in this report.If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.Manufacturer's reference number: (b)(4).

Manufacturer Narrative

It was reported that a patient underwent an atrial tachycardia right (r-at) procedure with a celsius¿ electrophysiology catheter.The physician unpacked the product to use in the procedure.Then he found that the tip of the catheter had more curliness than usual.There was no patient consequence.Additional information was received.The damage resulted in wires being exposed.The investigation was completed on 01-feb-2024.A picture was received for evaluation following biosense webster's procedures.According to pictures provided by the customer, the tip was observed bent, no sharp edges or wires exposed was observed.The customer complaint was confirmed based on the picture received.The product was returned to biosense webster (bwi) for evaluation.A visual inspection and tilt test of the returned device was performed following bwi procedures.Visual analysis revealed tip slightly bent but not broken.A tilt test was performed and the bent tip was found within specifications.A manufacturing meeting was performed due to the bent tip and it was concluded that the catheter was manufactured according to process instructions and met quality requirements prior to release.The product was manufactured following the specifications and procedures.A manufacturing record evaluation was performed and no internal action was found during the review.The issue reported by the customer could not be confirmed during the product investigation; other issues or circumstances may have occurred during the usage of the device that compromised its performance.As part of biosense webster's quality process, all devices are manufactured, inspected, and released to approved specifications.This product issue will be addressed through bwi's quality system.Explanation of codes: -investigation findings: no device problem found (c19)/ investigation conclusions: no problem detected (d14) were selected as related to the customer¿s reported ¿the tip of the catheter had more curliness than usual and the damage resulted in wires being exposed¿.-investigation findings: appropriate term/code not available (c22) / investigation conclusions: cause not established (d15) / component code: tip (g04129) were selected as related to the picture provided.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: CELSIUS¿ ELECTROPHYSIOLOGY CATHETER
• Type of Device: ELECTRODE, PERCUTANEOUS, CONDUCTION TISSUE ABLATION
• 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: 18330067
• MDR Text Key: 331049845
• Report Number: 2029046-2023-02961
• Device Sequence Number: 1
• Product Code: LPB
• UDI-Device Identifier: 10846835006056
• UDI-Public: 10846835006056
• Combination Product (y/n): N
• Reporter Country Code: TH
• PMA/PMN Number: P950005/S1
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 02/25/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/14/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: D7TBL252RT
• Device Lot Number: 30867368M
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/26/2023
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 02/01/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/14/2022
• 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