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

Model Number D134805

Device Problem Expiration Date Error (2528)

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

Event Date 04/05/2021

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

It was reported that the customer received an expired thermocool® smart touch® sf bi-directional navigation catheter.There¿s no indication that the device was used on any patient.As such, there were no patient consequences reported.No further information is available.Should more information become available, it will be reviewed and processed accordingly.

Manufacturer Narrative

Device investigation details: the device investigation has been completed which included a manufacturing record evaluation (mre).The manufacturing record evaluation was performed for the finished device 30296574m number, and no internal action related to the complaint was found during the review.Information available indicates that the device is not available for return, 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 ref # (b)(4).

• Brand Name: THERMOCOOL SMART TOUCH SF BI-DIRECTIONAL NAVIGATION
• Type of Device: CARDIAC ABLATION PERCUTANEOUS CATHETER
• Manufacturer (Section D): BIOSENSE WEBSTER INC; 33 technology drive; irvine CA 92618
• MDR Report Key: 11750888
• MDR Text Key: 266684090
• Report Number: 2029046-2021-00692
• Device Sequence Number: 1
• Product Code: LPB
• UDI-Device Identifier: 10846835010183
• UDI-Public: 10846835010183
• Combination Product (y/n): N
• PMA/PMN Number: P030031
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Type of Report: Initial,Followup
• Report Date: 04/05/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 09/29/2022
• Device Model Number: D134805
• Device Catalogue Number: D134805
• Device Lot Number: 30296574M
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 04/05/2021
• Initial Date FDA Received: 04/29/2021
• Supplement Dates Manufacturer Received: 07/15/2021
• Supplement Dates FDA Received: 07/15/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1