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

Model Number D134805

Device Problem Contamination /Decontamination Problem (2895)

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

Event Date 11/18/2022

Event Type  malfunction  

Event Description

It was reported that a patient underwent an atrial fibrillation (afib) ablation procedure with a thermocool® smart touch® sf bi-directional navigation catheter there was physical damage to the catheter allowing blood to get inside the plastic of the catheter.It was reported by the bwi representative that during a procedure when exchanging the thermocool® smart touch® sf bi-directional navigation catheter for an octaray catheter, blood got "inside the plastic portion of the catheter that was housing the spring." they are reporting "physical damage" to the catheter.To troubleshoot the physician tried wiping it off manually.This did not resolve the issue.They then replaced the catheter, the issue was resolved, and the procedure continued.The device was used with a carto vizigo¿ 8.5f bi-directional guiding sheath.There was no difficulty experienced while maneuvering the catheter or during the withdrawal.They do not recall if the catheter pebax was physically damaged.

Manufacturer Narrative

Device investigation details: a picture was received and evaluated by following biosense webster's procedures.According to pictures provided by the customer, blood was observed inside the p ebax, no external damages were observed on the device; however foreign material like a kind of lubricant was observed along the tip of the device.The source of the foreign material remains unknown at this time.A manufacturing record evaluation was performed, and no internal actions related to the reported complaint condition were identified.The customer complaint was confirmed based on the picture received.The device has not been returned for analysis and a root cause is unable to be assigned based on the current evidence.If the device is received in the future, the product investigation will be performed and updated accordingly, and any action will be taken if necessary.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

On 19-dec-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 an atrial fibrillation (afib) ablation procedure with a thermocool® smart touch® sf bi-directional navigation catheter there was physical damage to the catheter allowing blood to get inside the plastic of the catheter.It was reported by the bwi representative that during a procedure when exchanging the thermocool® smart touch® sf bi-directional navigation catheter for an octaray catheter, blood got "inside the plastic portion of the catheter that was housing the spring." they are reporting "physical damage" to the catheter.To troubleshoot the physician tried wiping it off manually.This did not resolve the issue.They then replaced the catheter, the issue was resolved, and the procedure continued.Device evaluation details: the device was returned to biosense webster inc (bwi) for evaluation and the evaluation has been completed.A visual inspection a of the returned device was performed following bwi procedures.According to the picture provided by the customer, reddish material was observed inside the pebax, however, the device was returned and no material was observed inside the pebax.Visual analysis revealed that there was a hole on the surface of the tip area.The hole at the pebax could be related to the issue reported by de customer.All units are inspected prior to leaving the facility as there are functional tests and inspections at control points based on the process flow diagram (pfd) per its part number to avoid this type of damage from leaving the facility.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.The instructions for use (ifu) contain the following recommendations: in order to prevent damage to the catheter tip, use the insertion tube supplied with the catheter to advance or retract the catheter through the hemostasis valve of the sheath.After insertion, slide the insertion tube back toward the handle.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® SF BI-DIRECTIONAL NAVIGATION CATHETER
• Type of Device: CARDIAC ABLATION PERCUTANEOUS CATHETER
• 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: kate karberg ; 31 technology dr; irvine, CA 92618 ; 3035526892
• MDR Report Key: 15993644
• MDR Text Key: 308243875
• Report Number: 2029046-2022-03147
• 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: Health Professional,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date: 02/10/2023

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 Model Number: D134805
• Device Catalogue Number: D134805
• Device Lot Number: 30875985L
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 11/18/2022
• Initial Date FDA Received: 12/16/2022
• Supplement Dates Manufacturer Received: 12/19/2022; 01/17/2023
• Supplement Dates FDA Received: 01/10/2023; 02/10/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/25/2022
• 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
• Treatment: THMCL SMTCH SF BID, TC, D-F.; UNK_OCTARAY NAV.