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

Model Number D134804

Device Problems Display or Visual Feedback Problem (1184); Material Puncture/Hole (1504); Communication or Transmission Problem (2896)

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

Event Date 09/15/2020

Event Type  malfunction  

Manufacturer Narrative

The biosense webster, inc.Product analysis lab received the device for evaluation.The device evaluation was completed on 11/12/2020.The device was visually inspected and a hole was found on the pebax.Then, magnetic sensor functionality was tested on the carto and the catheter failed, error 106 was observed.A failure analysis was performed and the catheter was dissected on the tip area, loss of electrical continuity from cut to sensor was found.It was determined that the root cause was an internal failure of the sensor.A manufacturing record evaluation was performed and no internal action was found during the review.The customer complaint was confirmed.The root cause of the hole on pebax 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.This issue was highly detectable by the physician.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 a hole on the pebax.Initially it was reported the carto 3 system was not recognizing or displaying the catheter when it was connected to the patient interface unit.No error messages were displayed.To troubleshoot the cable was reseated and replaced without resolution.The catheter was replaced and the issue was resolved.The procedure was continued.No patient consequences was reported.The carto recognition issue was assessed as not mdr reportable.The device can not be recognized by the carto system; therefore, the user will not be able to use the device and will have to replace it.The most likely consequence was an intraprocedural delay.The potential risk that it could cause or contribute to a serious injury or death was remote.The visualization issue was assessed as not mdr reportable.The device was not visualized by the carto system.The user will have to replace the catheter in order to complete the case.The most likely consequence was an intraprocedural delay.The potential risk that it could cause or contribute to a serious injury or death was remote.The biosense webster inc.Product analysis lab received the device for evaluation and observed on 11/2/2020 a hole on the pebax.The returned condition of the hole on the pebax was assessed as a mdr reportable issue.The awareness date for this finding is (b)(6) 2020.

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 12/1/2020, noted a correction to the 3500a initial as the h6.Medical device problem code of "material puncture/hole" was omitted in error.Therefore, this code has been added.

Manufacturer Narrative

Additional information was received on 2/16/2021 stating there were two catheters that were replaced one after another.Both products received belong to the same complaint and were both with failures.Therefore, added a concomitant product of thmcl smtch sf bid, tc, f-j under d10.Concomitant medical products and therapy dates.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 BI-DIRECTIONAL NAVIGATION CATHETER
• Type of Device: CARDIAC ABLATION PERCUTANEOUS CATHETER
• Manufacturer (Section D): BIOSENSE WEBSTER INC; 33 technology drive; irvine CA 92618
• MDR Report Key: 10916658
• MDR Text Key: 219369652
• Report Number: 2029046-2020-01819
• Device Sequence Number: 1
• Product Code: LPB
• UDI-Device Identifier: 10846835010176
• UDI-Public: 10846835010176
• Combination Product (y/n): N
• PMA/PMN Number: P030031
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Type of Report: Initial,Followup,Followup
• Report Date: 09/15/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/29/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 05/18/2021
• Device Model Number: D134804
• Device Catalogue Number: D134804
• Device Lot Number: 30376803M
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/05/2020
• Date Manufacturer Received: 02/16/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: CARTO 3 SYSTEM.; THMCL SMTCH SF BID, TC, F-J.; UNKNOWN BRAND CABLE.; UNKNOWN BRAND CATHETER.