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 05/02/2023

Event Type  malfunction  

Event Description

It was reported that a patient underwent an ablation procedure with a thermocool® smart touch® sf bi-directional navigation catheter and foreign material inside the packaging outside of specification issue occurred.A foreign particle was found in the product when it was opened.Timing occurred at the time of opening the package.This issue was resolved by replacing the thermocool® smart touch® sf bi-directional navigation catheter to another new one.The procedure was completed without patient's consequence.Additional information was received.The customer discarded the foreign material with the package.Therefore, only the thermocool® smart touch® sf bi-directional navigation catheter will be returned.The event was assessed as mdr reportable for foreign material inside the packaging outside of specification.

Manufacturer Narrative

E1.Initial reporter phone: (b)(6).The product has not returned for analysis, however, a picture was provided by the customer.Evaluation is still in progress.The 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.This report is being submitted pursuant to the provisions of 21 cfr, part 803.This report may be based on information which has not been investigated or verified prior to the required reporting date.This report does not reflect a conclusion by biosense webster, inc., or its employees that the report constitutes an admission that the product, biosense webster, inc., or its employees caused or contributed to the potential event described in this report.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).

Manufacturer Narrative

The bwi product analysis lab received the device for evaluation on 07-jun-2023.The 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 reference number: (b)(4).

Manufacturer Narrative

Additional information was received on 13-jun-2023.The foreign particle was in the tray.The packaging and the foreign material were accidentally discarded at the agent.The device was not used on the patient.The investigation was completed on 26-jun-2023.It was reported that a patient underwent an ablation procedure with a thermocool® smart touch® sf bi-directional navigation catheter and foreign material inside the packaging outside of specification issue occurred.A picture was received for evaluation following biosense webster's procedures.According to pictures provided by the customer, a foreign material was observed inside the pouch of the device; however, according to the information received the particle was observed after the device was opened and it is not possible to determine the source of the particle.The customer complaint was confirmed based on the picture received.The product analysis was performed as appropriate in order to find the root cause of the complaint.The device was returned to biosense webster (bwi) for evaluation.A visual inspection evaluation of the returned device was performed following bwi procedures.Visual analysis revealed no damage or anomalies on the device.It was found in good condition.According to the picture provided by the customer, a foreign particle was observed inside the packaging; however, the package of the device was not returned for further analysis.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 could not be replicated during the product investigation; other issues or circumstances may have occurred during the usage of the device that compromised its performance.As part of biosense webster¿s quality process, all devices are manufactured, inspected, and released to approved specifications.Explanation of codes: picture analysis; -investigation findings: appropriate term/code not available (c22) / investigation conclusions: cause not established (d15) were selected as related to the picture provided.-investigation findings: inappropriate material (c0602) / investigation conclusions: cause not established (d15) / component code: packaging (g04094) were selected as related to the customer¿s reported ¿foreign material¿.Device evaluation; -investigation findings: no findings available (c20) / investigation conclusions: appropriate term/code not available (d17) / component code: appropriate term/code not available (g07002) were selected as we were unable to analyze due to the product return condition.If additional information is received regarding this event, a supplemental 3500a report will be submitted to the fda.Manufacturer's reference number: (b)(6).

• 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: 17017290
• MDR Text Key: 316092196
• Report Number: 2029046-2023-01168
• Device Sequence Number: 1
• Product Code: LPB
• UDI-Device Identifier: 10846835010183
• UDI-Public: 10846835010183
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: P030031
• 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: 07/10/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/29/2023
• 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: 30985739L
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 06/13/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/16/2023
• 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: UNKNOWN BRAND CATHETER