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

Model Number D134804

Device Problem Device Sensing Problem (2917)

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

Event Date 10/12/2020

Event Type  malfunction  

Manufacturer Narrative

Device evaluation details: the device evaluation has been completed.The device was visually inspected and it was found reddish material inside the pebax.A hole was also observed in the pebax.Then, the sensor functionality was tested on carto 3 system and the catheter failed, errors 105 and 106 were observed.A failure analysis was performed, the catheter was dissected and the sensor values were found within specifications.With this information, the failure can be attributed to a potential pc board failure.A manufacturing record evaluation was performed and no internal action related to the reported complaint were identified.The customer complaint was confirmed.The root cause of the pc board failure cannot be determined.The root cause of the damage 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.The reddish material inside the pebax also can be related to the force sensor issue.The instructions for use (ifu) states that careful catheter manipulation must be performed to avoid cardiac damage, perforation or tamponade.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

A patient underwent an ablation procedure with a thermocool¿ smart touch¿ sf bi-directional navigation catheter for which biosense websters product analysis lab identified a hole on the pebax.It was initially reported by the customer that upon connection of the device, a ¿catheter sensor error occurred.Disconnecting and connecting the device did not resolve the issue.Use of another cable (3434ct) did not solve the issue.Another thermocool¿ smart touch¿ sf bi-directional navigation catheter was used.There was no patient consequence.On 11/3/2020, the bwi product analysis lab received the complaint device for evaluation.On 12/1/2020, the device was inspected and it was found with reddish material inside the pebax along with a hole in the pebax.These findings were reviewed and the hole in the pebax was assessed as an mdr reportable malfunction.

Manufacturer Narrative

If additional information is received regarding this event, a supplemental 3500a report will be submitted to the fda.Manufacturer's ref.# (b)(4) on (b)(6) 2020, it was noticed that the following information was inadvertently omitted from section b5.Event description of the initial 3500a medwatch: "the customer's reported catheter sensor issue is not considered to be mdr reportable since the catheter can not be used on patient and must be replaced." additionally, the concomitant products were omitted from section d11.Concomitant med.Products.The product have now been added.

• 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: 11081097
• MDR Text Key: 251097385
• Report Number: 2029046-2020-01994
• 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,foreig
• Type of Report: Initial,Followup
• Report Date: 10/12/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/28/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 08/03/2021
• Device Model Number: D134804
• Device Catalogue Number: D134804
• Device Lot Number: 30412871L
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/03/2020
• Date Manufacturer Received: 12/29/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: CBL, 34 HYP/34 LEMO, 10'; THMCL SMTCH SF BID, TC, F-J