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

Model Number D133602

Device Problem Expiration Date Error (2528)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 01/16/2020

Event Type  malfunction  

Manufacturer Narrative

If additional information is received regarding this event, a supplemental 3500a report will be submitted to the fda.(b)(4).

Event Description

A customer reported receiving an expired thermocool® smart touch¿ electrophysiology catheter with a lot number of 30149564m.The customer reported that the expired product was not distributed to any hospital and was not used on any patient, therefore there was no patient consequence.A preliminary investigation found that this expired item was part of a shipment containing more 15 other non-expired products.The expired product was shipped from the distribution center in (b)(4) to the distributor energy comercio de produtos médico hospitalares ltda.The distributor identified the issue and the product will be returned to the johnson & johnson distribution center.The expiration date in ¿sap btb¿ for the product was january 2, 2022, however, on the physical label, the expiration date was described as january 3, 2020.On the national invoice, the expiration date was january 3, 2022.The importation document (ibd) was also received by international trade with the wrong expiration date.There was no other unit available in the distribution center nor shipped to other customer.The reported issue of expired product being shipped has been assessed as an mdr reportable malfunction.

Manufacturer Narrative

A customer reported receiving an expired thermocool® smart touch¿ electrophysiology catheter with a lot number of 30149564m.The expiration date in ¿sap btb¿ for the product was january 2, 2022.However, on the physical label, the expiration date was described as january 3, 2020.On the national invoice, the expiration date was january 3, 2022.The importation document (ibd) was also received by international trade with the wrong expiration date.The photo investigational analysis completed 5/19/2020.Based in the information obtained from the review, it is concluded that the complaint is related to the preparation of the certificate of analysis (coa) and was caused due to a human error during the delivery of a coa with incorrect lot expiration date.This complaint is considered an isolated event, limited to coa of involved lot number.Additionally, this is the first complaint received to a mis-match between the product expiration date and the certificate of analysis provided for a single unit shipped to the distribution center in brazil.No other complaints of the same nature has been reported for this lot number.Bwi and edc erp systems were not contributing to this error on any way.As mentioned below, this was a human error related to coa preparation.An internal corrective action has been opened to investigate expired product being shipped.A picture was received displaying that the catheter packaging was received for analysis.Manufacturing and expiration date were observed on the device packaging.A manufacturing record evaluation was performed and no internal actions were identified.Customer complaint was confirmed.However, the device has not been returned for analysis.If the device is received in the future, the product analysis will be performed.Manufacture ref no: (b)(4).

• Brand Name: THERMOCOOL® SMART TOUCH¿ ELECTROPHYSIOLOGY CATHETER
• Type of Device: CARDIAC ABLATION PERCUTANEOUS CATHETER
• Manufacturer (Section D): BIOSENSE WEBSTER INC; 33 technology drive; irvine CA 92618
• MDR Report Key: 9702421
• MDR Text Key: 200452196
• Report Number: 2029046-2020-00226
• Device Sequence Number: 1
• Product Code: LPB
• UDI-Device Identifier: 10846835009002
• UDI-Public: 10846835009002
• Combination Product (y/n): N
• PMA/PMN Number: P030031/S053
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 01/27/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/12/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 01/03/2020
• Device Model Number: D133602
• Device Catalogue Number: D133602
• Device Lot Number: 30149564M
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 05/19/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1