MAUDE Adverse Event Report: BIOSENSE WEBSTER INC CELSIUS¿ ELECTROPHYSIOLOGY CATHETER; UNI-DIRECTIONAL CELSIUS FLTR CATHETER

Model Number D135502

Device Problem Expiration Date Error (2528)

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

Event Date 02/03/2023

Event Type  malfunction  

Manufacturer Narrative

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.Biosense webster manufacturer's reference number (b)(4) has four reports: mfr # 2029046-2023-00553 for product code d135502 (celsius¿ electrophysiology catheter).This initial mfr for product code d135502 (celsius¿ electrophysiology catheter).Mfr # 2029046-2023-00555 for product code d135502 (celsius¿ electrophysiology catheter).Mfr # 2029046-2023-00556 for product code d135502 (celsius¿ electrophysiology catheter).

Event Description

It was reported that expired products (celsius¿ electrophysiology catheter qty 4) were received.According to the customer, expiration date label on product show 22-sep-2022.The customer received the products on 03-feb-2023.No patient was involved.The expired product shipped issue is mdr reportable to the fda.

Manufacturer Narrative

The investigation was completed on 20-apr-2023 it was reported that expired products (celsius¿ electrophysiology catheter qty 4) were received.According to the customer, expiration date label on product show 22-sep-2022.The customer received the products on 03-feb-2023.No patient was involved.During the investigation, it was noticed that the devices stated on this complaint were physically reworked (relabeled) at the distribution center between 25 april 2022 and 17 may 2022.The information and details should have been adjusted in the system.The four ((b)(4)) units were returned to the warehouse.No additional expired product was distributed.No other sales occurred on the products.No products were shipped from the distribution center to final customer.Finally, the devices were destroyed locally and therefore, were not returned to the product analysis lab for evaluation.A manufacturing record evaluation was performed for the finished device (b)(4) number, and no internal actions related to the reported complaint condition were identified.This complaint was escalated for further investigation.H 6.Investigation conclusions code of ¿appropriate term/code not available (d17)¿ refers to the reported device not returned for analysis.If additional information is received regarding this event, a supplemental 3500a report will be submitted to the fda.Biosense webster manufacturer's reference number (b)(4) has four reports: (1) mfr # 2029046-2023-00553 for product code d135502 (celsius¿ electrophysiology catheter), (2) mfr # 2029046-2023-00554 for product code d135502 (celsius¿ electrophysiology catheter), (3) mfr # 2029046-2023-00555 for product code d135502 (celsius¿ electrophysiology catheter), (4) mfr # 2029046-2023-00556 for product code d135502 (celsius¿ electrophysiology catheter).

• Brand Name: CELSIUS¿ ELECTROPHYSIOLOGY CATHETER
• Type of Device: UNI-DIRECTIONAL CELSIUS FLTR 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: 16553986
• MDR Text Key: 311602980
• Report Number: 2029046-2023-00554
• Device Sequence Number: 1
• Product Code: LPB
• UDI-Device Identifier: 10846835013078
• UDI-Public: 10846835013078
• Combination Product (y/n): N
• Reporter Country Code: LH
• PMA/PMN Number: P010068/S031
• 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,Followup
• Report Date: 05/17/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/16/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 09/22/2022
• Device Model Number: D135502
• Device Catalogue Number: D135502
• Device Lot Number: 30638986MA
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 04/20/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/23/2021
• 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: 8MM CELSIUS DS FL UNI-DIR, XR.; 8MM CELSIUS DS FL UNI-DIR, XR.; 8MM CELSIUS DS FL UNI-DIR, XR.