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

Model Number D134805

Device Problem Sharp Edges (4013)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 06/01/2020

Event Type  malfunction  

Manufacturer Narrative

The biosense webster, inc.Product analysis lab received the device for evaluation.The device evaluation summary was completed on july 6, 2020.The device was visually inspected and electrode #4 was found damaged.The damage on the electrode cannot be determined.An electrical test was performed on the catheter and it was found within specifications.No electrical malfunction was observed.A manufacturing record evaluation was performed for the finished device 30356957m number, and no internal actions related to the reported complaint condition were identified.The issue reported noise on the distal electrodes cannot be confirmed. the root cause of the damage on electrode cannot be related to the manufacturing process since there is evidence that the device was manufactured in accordance with documented specification and procedures.It could be related to the handling of the device during the procedure; however, this cannot be conclusively determined.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 an atrial fibrillation (afib) procedure with a thermocool® smart touch® sf bi-directional navigation catheter and the biosense webster, inc.Product analysis lab observed that electrode #4 was damaged.Initially it was reported that the thermocool® smart touch® sf bi-directional navigation catheter was displaying noise on the distal electrodes.The noise was displayed on both the recording system and the carto 3 system.They disconnected and reconnected the catheters and the issue persisted.The cable was exchanged and the issue persisted.The catheter was exchanged and the issue was resolved.The carto 3 system was working per specifications.They reported that the catheter has been determined to be the root cause of the complaint.The noise issue was assessed as not mdr reportable as the risk to the patient was low.The biosense webster, inc.Product analysis lab received the device for evaluation and observed on july 1, 2020 that electrode #4 was damaged.The returned condition of the electrode damage was assessed as a mdr reportable issue.The awareness date is july 1, 2020.

• Brand Name: THERMOCOOL SMART TOUCH SF BI-DIRECTIONAL NAVIGATION CATHETER
• Type of Device: CARDIAC ABLATION PERCUTANEOUS CATHETER
• Manufacturer (Section D): BIOSENSE WEBSTER INC; 33 technology drive; irvine CA 92618
• Manufacturer (Section G): BIOSENSE WEBSTER INC (JUAREZ); circuito interior norte; 1820parque industrial salvacar; juarez 32599 ; MX 32599
• Manufacturer Contact: gabriel alfageme ; 31 technology drive; irvine, CA 92618 ; 949789-868
• MDR Report Key: 10342300
• MDR Text Key: 202236956
• Report Number: 2029046-2020-00970
• Device Sequence Number: 1
• Product Code: LPB
• UDI-Device Identifier: 10846835010183
• UDI-Public: 10846835010183
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P030031
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 06/01/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/29/2020
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 02/21/2021
• Device Model Number: D134805
• Device Catalogue Number: D134805
• Device Lot Number: 30356957M
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/29/2020
• Date Manufacturer Received: 07/01/2020
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/22/2020
• 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