MAUDE Adverse Event Report: BIOSENSE WEBSTER INC THERMOCOOL SMART TOUCH SF UNI-DIRECTIONAL NAVIGATION CATHETER; CARDIAC ABLATION PERCUTANEOUS CATHETER

Model Number D134702

Device Problem Expiration Date Error (2528)

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

Event Date 01/20/2021

Event Type  malfunction  

Manufacturer Narrative

(b)(6).The device has been reported as discarded, therefore no product investigation can be performed, and the customer complaint cannot be confirmed.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 a cardiac ablation procedure on (b)(6) 2021 with a thermocool® smart touch® sf uni-directional navigation catheter and a "expired product shipped" issue occurred.Product expiration date was 1/12/2021.It was also reported that they confirmed the product was delivered to the hospital on (b)(6) 2021.Multiple attempts have been made to obtain clarification to this complaint.However, no further information has been made available.With the available information, this is event was assessed as a mdr reportable ¿expired product shipped¿ issue.Should more information become available, it will be reviewed and processed accordingly.Per product instructions for use: the catheter is sterilized with ethylene oxide gas and should be used by the ¿use by¿ date on the device package.Do not use the catheter if past the ¿use by¿ date.

Manufacturer Narrative

It was reported that a patient underwent a cardiac ablation procedure on (b)(6) 2021 with a thermocool® smart touch® sf uni-directional navigation catheter and a "expired product shipped" issue occurred.In the 3500a initial it was reported that the device had been reported as discarded.The investigation summary was completed on 4/13/2021.An investigation was performed.It was clarified that j&j sold the catheter to a third-party distributor in november 2020 prior to the device expiration date in january 2021.Per the local health authority regulation, products should be commercialized within the expiration date.There¿s no requirement to commercialize it at a minimum period.As such, the product was sold in accordance with specification.On march 23, 2021, it was decided that no further assessment is required.A manufacturing record evaluation was performed for the finished device 30327913l 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.H6.Investigation conclusions code of ¿appropriate term/code not available¿ represents that the product was sold in accordance with specification.Manufacturer's reference number: (b)(4).

• Brand Name: THERMOCOOL SMART TOUCH SF UNI-DIRECTIONAL NAVIGATION CATHETER
• Type of Device: CARDIAC ABLATION PERCUTANEOUS CATHETER
• Manufacturer (Section D): BIOSENSE WEBSTER INC; 33 technology drive; irvine CA 92618
• MDR Report Key: 11387657
• MDR Text Key: 253614529
• Report Number: 2029046-2021-00241
• Device Sequence Number: 1
• Product Code: LPB
• UDI-Device Identifier: 10846835009781
• UDI-Public: 10846835009781
• Combination Product (y/n): N
• PMA/PMN Number: P030031
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional
• Type of Report: Initial,Followup
• Report Date: 01/28/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/26/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 01/12/2021
• Device Model Number: D134702
• Device Catalogue Number: D134702
• Device Lot Number: 30327913L
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 04/13/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1