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

Model Number D134701

Device Problems Partial Blockage (1065); Contamination /Decontamination Problem (2895)

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

Event Date 05/02/2023

Event Type  malfunction  

Manufacturer Narrative

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).

Event Description

It was reported that a patient underwent a procedure with a thermocool® smart touch® sf uni-directional navigation catheter and foreign material was on the usable length of the catheter.Presence of a film at the end of the probe.Altered purging.Replacement with an equivalent probe.There was no patient consequence reported.Additional information was received.Yellow-brown gel on distal electrode.It was hooked but with movement along the electrode.The issue was noticed during the preparation of the catheter (purge), that is to say before the catheter was in the patient.Photo provided.The device was not used on the patient.The event was assessed as mdr reportable for foreign material on the usable length of the catheter.

Manufacturer Narrative

If additional information is received regarding this event, a supplemental 3500a report will be submitted to the fda.Manufacturer's reference number: (b)(4).During an internal review on (b)(6) 2023, noted a correction to the 3500a follow-up #1 as under h6.Type of investigation should have included ¿device not returned (b17)¿.

Manufacturer Narrative

It was reported that a patient underwent a procedure with a thermocool® smart touch® sf uni-directional navigation catheter.Presence of a film at the end of the probe.Altered purging.Replacement with an equivalent probe.There was no patient consequence reported.The picture investigation was completed on 04-jul-2023.A picture was received for evaluation following biosense webster's procedures.According to the picture provided by the customer, foreign material was observed on the tip of the catheter.The foreign material could be related to the irrigation issue reported by the customer; however, this cannot be conclusively determined.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.However, the device has not been returned for evaluation.Since no device has been received, no product investigation can be performed.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.Explanation of codes: investigation findings: appropriate term/code not available (c22) / investigation conclusions: cause not established (d15) were selected as related to the photo provided.Investigation findings: inappropriate material (c0602) / investigation conclusions: cause not established (d15) / component code: appropriate term/code not available (g07002) were selected as related to the customer¿s reported ¿film at the end of the probe¿ issue.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

The bwi product analysis lab received the device for evaluation on 14-sep-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

It was reported that a patient underwent a procedure with a thermocool® smart touch® sf uni-directional navigation catheter.Presence of a film at the end of the probe.Altered purging.Replacement with an equivalent probe.There was no patient consequence reported.The investigation evaluation was completed on 09-nov-2023.A picture was received for evaluation following biosense webster's procedures.According to the picture provided by the customer, foreign material was observed on the tip of the catheter.The foreign material could be related to the irrigation issue reported by the customer; however, this cannot be conclusively determined.The customer complaint was confirmed based on the picture received.The device was returned to biosense webster (bwi) for evaluation.A visual inspection, cool flow pump, pressure gauge, and fourier transformed infrared spectroscopy (ft-ir) test of the returned device was performed following bwi procedures.Visual inspection was performed and a film of foreign material was observed on the tip.An ft-ir test was performed and results revealed that the foreign material is mainly a biological based material according to characteristic absorption bands.Presumably a tissue or fluid from the patient.An irrigation test was performed and the catheter was irrigating correctly.A manufacturing record evaluation was performed for the finished device batch number, and no internal actions were identified.The foreign material issue reported by the customer was confirmed.It should be noted that device failure is multifactorial.In the other hand, the irrigation issue 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.The instructions for use contain the following recommendations: flush the catheter with heparinized saline prior to insertion into the body.As part of biosense webster's quality process, all devices are manufactured, inspected, and released to approved specifications.This product issue will be addressed through bwi's quality system.Explanation of codes: -investigation findings: no device problem found (c19) / investigation conclusions: no problem detected (d14) were selected as related to the customer¿s reported issue of ¿altered purging¿.-investigation findings: inappropriate material (c0602) / investigation conclusions: cause not established (d15) / component code: tip (g04129) were selected as related to the customer¿s reported issue of ¿film at the end of the probe¿.-investigation findings: appropriate term/code not available (c22) / investigation conclusions: cause not established (d15) were selected as related to the photo provided.If additional information is received regarding this event, a supplemental 3500a report will be submitted to the fda.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
• 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: 17057416
• MDR Text Key: 317487766
• Report Number: 2029046-2023-01220
• Device Sequence Number: 1
• Product Code: LPB
• UDI-Device Identifier: 10846835009774
• UDI-Public: 10846835009774
• Combination Product (y/n): N
• Reporter Country Code: FR
• 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,Followup,Followup
• Report Date: 12/06/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/05/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: D134701
• Device Catalogue Number: D134701
• Device Lot Number: 31002495L
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 11/09/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/14/2023
• 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