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

Model Number D134701

Device Problems Break (1069); Material Deformation (2976)

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

Event Date 08/19/2021

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

It was reported that a patient underwent an atrial tachycardia (at ¿ right) ablation procedure with a thermocool® smart touch® sf uni-directional navigation catheter (stsf) and a broken tip issue occurred.The introducer on the thermocool stsf catheter was physically damaged before it was inserted into the patient.It was reported that the "tip broke off" and was "sharp." the physician cut the damaged part off of the thermocool stsf catheter and the procedure continued successfully.Additional information was received and it was reported that the tip was not detached from the rest of the catheter.There were no detached parts of the catheter.There was no issue with inserting the catheter once the damaged portion of the introducer was removed.The catheter was not pre-shaped.No adverse patient consequence was reported.

Manufacturer Narrative

The biosense webster inc.(bwi) product analysis lab received the device for evaluation on 15-sep-2021.The device evaluation was completed on 11-oct-2021.It was reported that a patient underwent an atrial tachycardia (at ¿ right) ablation procedure with a thermocool® smart touch® sf uni-directional navigation catheter (stsf) and a broken tip issue occurred.The introducer on the thermocool stsf catheter was physically damaged before it was inserted into the patient.It was reported that the "tip broke off" and was "sharp." the physician cut the damaged part off of the thermocool stsf catheter and the procedure continued successfully.Additional information was received and it was reported that the tip was not detached from the rest of the catheter.There were no detached parts of the catheter.There was no issue with inserting the catheter once the damaged portion of the introducer was removed.The catheter was not pre-shaped.No adverse patient consequence was reported.Device evaluation details: according to the picture provided by the customer, the introducer appeared broken.The customer complaint was confirmed based on the picture received.The product was returned to biosense webster for evaluation.Bwi conducted a visual inspection of the returned device.Visual analysis of the returned sample revealed that no damage or anomalies were observed on the thermocool® smart touch® sf uni-directional navigation catheter (stsf).A manufacturing record evaluation was performed for the finished device 30593622l number, and no internal action related to the complaint was found during the review.Based on the mre, the d4.Expiration date, as well as the h4.Device manufacture date were updated.As part of bwi¿s quality process, all devices are manufactured, inspected, and released to approved specifications.The event described could not be confirmed since the introducer was not received, it could not be analyzed, and the device was found in good conditions.There may have been other circumstances or issues that occurred during the use of the device that could not be replicated during the laboratory analysis.If additional information is received regarding this event, a supplemental 3500a report will be submitted to the fda.H6.Investigation findings code of "appropriate term/code not available" represents photo/video analysis.H6.Investigation findings code of mechanical problem identified refers to the analysis of the picture received where the introducer appeared broken.The code of no device problem found refers to the analysis of the returned sample where no damage or anomalies were observed.H6.Investigation conclusions code of "appropriate term/code not available¿ represents unable to analyze due to product returned condition.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; 31 technology drive, suite 200; irvine CA 92618
• MDR Report Key: 12474108
• MDR Text Key: 271468605
• Report Number: 2029046-2021-01553
• Device Sequence Number: 1
• Product Code: LPB
• UDI-Device Identifier: 10846835009774
• UDI-Public: 10846835009774
• 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: 10/12/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/15/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 07/05/2022
• Device Model Number: D134701
• Device Catalogue Number: D134701
• Device Lot Number: 30593622L
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/15/2021
• Date Manufacturer Received: 09/15/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: UNKNOWN PREFACE SHEATH MP 8.5FR.; UNKNOWN PREFACE SHEATH MP 8.5FR