MAUDE Adverse Event Report: BIOSENSE WEBSTER INC THERMOCOOL® SMART TOUCH¿ ELECTROPHYSIOLOGY CATHETER; SIMILAR DEVICE D133601, PMA # P030031/S053

Catalog Number D133604IL

Device Problems Break (1069); Positioning Problem (3009)

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

Event Date 08/15/2022

Event Type  malfunction  

Manufacturer Narrative

Device investigation details: a picture was received for evaluation following biosense webster's procedures.According to pictures provided by the customer, the tip of the catheter was observed with a kinked/bent condition, however, no exposed wires was observed, due the kinked/bent condition the damage reported event was confirmed.The photo does not provide sufficient information related to the deflection reported event and therefore no result can be obtained from it.A manufacturing record evaluation was performed, and no internal actions related to the reported complaint condition were identified.The customer complaint was confirmed from the photo analysis.However, the device has not been returned for evaluation.Since no device has been received, a root cause is unable to be assigned based on the current evidence.If the device is received in the future, the product analysis will be performed as appropriate in order to find the root cause of the complaint.The ¿suspected medical device¿ reported in section d of this report is not marketed in usa or approved by the fda.However, it is being reported as biosense webster considers this as a similar device to thermocool® smart touch¿ electrophysiology catheter approved under pma # p030031/s053.Initial reporter phone: (b)(6).Investigation findings code of ¿appropriate term/code not available¿ represents photo/video analysis.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 a patient underwent a paroxysmal atrial fibrillation (afib) ablation procedure with a thermocool® smart touch¿ electrophysiology catheter and a broken tip issue occurred.It was reported that before the operation, the tip of the catheter was found cracked with exposed wires.Additionally, the catheter was unable to deflect or relax completely.A second device was used to complete the operation.There was no adverse event reported on patient; the device was not used in patient.

Manufacturer Narrative

On 19-oct-2022, the bwi product analysis lab received the complaint device for evaluation.The product analysis has begun but is not completed at this time.When the investigational analysis has been completed, a supplemental 3500a report will be submitted.If additional information is received regarding this event, a supplemental 3500a report will be submitted to the fda.Manufacturer's ref.# (b)(4).

Manufacturer Narrative

It was reported that a patient underwent a paroxysmal atrial fibrillation (afib) ablation procedure with a thermocool® smart touch¿ electrophysiology catheter and a broken tip issue occurred.It was reported that before the operation, the tip of the catheter was found cracked with exposed wires.Additionally, the catheter was unable to deflect or relax completely.A second device was used to complete the operation.There was no adverse event reported on patient; the device was not used in patient.Device evaluation details: the device was returned to biosense webster inc (bwi) for evaluation and the evaluation has been completed.A visual inspection and deflection test of the returned device were performed following bwi procedures.Visual analysis revealed that the tip was damaged with internal parts exposed.Deflection testing was performed, and the deflection mechanism failed specifications due to the tip was damaged.It is determined that the defect occurred after its manufacturing process since the catheter was manufactured in accordance with the process and passed the final deflection test, inspections, and packing process.It is improbable that a device would levae the manufacturing process with exposed wires.This event cannot be considered manufacturing-related since there is evidence that confirms it was manufactured according to the work instructions.The damage observed could be related to excessive force during the procedure; however, this could not be conclusively determined.A manufacturing record evaluation was performed for the finished device batch number, and no internal actions were identified.The issue reported by the customer was confirmed.It should be noted that product failure is multifactorial.As part of biosense webster's quality process, all devices are manufactured, inspected, and released to approved specifications.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¿ ELECTROPHYSIOLOGY CATHETER
• Type of Device: SIMILAR DEVICE D133601, PMA # P030031/S053
• Manufacturer (Section D): BIOSENSE WEBSTER INC; 31 technology drive, suite 200; irvine CA 92618
• Manufacturer (Section G): BIOSENSE WEBSTER INC (JUAREZ); circuito interior norte; 1820parque industrial salvacar; juarez 32599 ; MX 32599
• Manufacturer Contact: michelleann garcia ; 31 technology dr; irvine, CA 92618 ; 646591-798
• MDR Report Key: 15393426
• MDR Text Key: 305009086
• Report Number: 2029046-2022-02171
• Device Sequence Number: 1
• Product Code: LPB
• Combination Product (y/n): N
• Reporter Country Code: CH
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date: 01/27/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/09/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 04/27/2023
• Device Catalogue Number: D133604IL
• Device Lot Number: 30776521M
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 01/13/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/28/2022
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: THMCL SMARTTOUCH,TC,D,C3,OBL