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

Catalog Number D134805

Device Problem Material Split, Cut or Torn (4008)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 12/06/2018

Event Type  malfunction  

Manufacturer Narrative

Since the product was not returned for analysis, no product failure analysis can be conducted and no determination of possible contributing factors could be made.The device history record (dhr) for the lot number 30061885l has been reviewed and it was verified that the device was manufactured in accordance with documented specifications and procedures.Manufacturer's ref.No: (b)(4).

Event Description

It was reported that a patient underwent a procedure with a thermocool® smart touch® sf bi-directional navigation catheter and the pebax was torn.During the procedure, the irrigation pump detected a bubble error.The physician removed the thermocool® smart touch® sf bi-directional navigation catheter and checked the catheter tip.The tip's rubber connecting part was torn.Therefore, blood flowed inside of the irrigation tip.The physician complained about it and then replaced the catheter.There was no other issue.Additional information was received.The abbott sl1 8.5f sheath was used.There was no difficulty experienced while maneuvering the catheter or during the withdrawal.After the catheter was changed, they flushed the saline (60cc rate) again and the bubble error was resolved.The bubble error was assessed as not reportable.The most likely consequence was an intraprocedural delay.The potential that it could cause or contribute to a death or serious injury, or other significant adverse event, was remote.The description of the pebax being torn was assessed as a reportable issue.

Manufacturer Narrative

Initially, it was reported that the tip's rubber connecting part was torn.Therefore, blood flowed inside of the irrigation tip.Therefore, the pebax reported as torn was assessed as a reportable issue.During 3500a follow-up we reported that the biosense webster inc.Product analysis lab received the device for evaluation on january 4, 2019 and noted during the visual inspection that there was reddish material under the pebax sleeve.The peek housing was cracked at the transitional area approximately 1.6 cm from the distal tip.There was reddish material under the peek housing in the cracked transition.The pebax and peek housing returned conditions were assessed as not reportable.However, a scanning electron microscope (sem) analysis was performed on january 24, 2019.The sem analysis shows evidence of mechanical damage, stress marks, scratches and a hole on the pebax surface.It is possible that the damage was generated with an unknown object.No other anomalies were observed.The hole on the pebax has been assessed as a reportable lab finding.Therefore, the pebax issue remains reportable.Additional information was received on february 3, 2019.The tubing was not exchanged.This was not due to a bubble error issue.The bubble was detected in the irrigation pump.Therefore, the bubble was not delivered to the catheter and was filtered.Investigation summary: it was reported that a patient underwent a procedure with a thermocool® smart touch® sf bi-directional navigation catheter.During the procedure, the irrigation pump detected a bubble error.The physician removed the thermocool® smart touch® sf bi-directional navigation catheter and checked the catheter tip.The tip's rubber connecting part was torn.Therefore, blood flowed inside of the irrigation tip.The physician complained about it and then replaced the catheter.There was no other issue.The device was inspected and reddish material was found inside the pebax, also, the peek housing tip transition was found cracked with reddish material.Then, deflection test was performed and the catheter failed.A failure analysis was performed and the catheter was observed under the x-ray machine and the t bar was found slid down causing the improper deflection condition.Additionally, a scanning electron microscope (sem) testing was performed on the pebax area and the results showed evidence of mechanical damage, stress marks, scratches and a hole on the pebax surface.It is possible that the damage was generated with an unknown object.No other anomalies were observed.The device history record (dhr) was reviewed and no anomalies were found related to this complaint.In addition, the dhr review verifies that the device was manufactured in accordance with documented specification and procedures.During manufacturing process, all the catheters are inspected for visual damages before packaging.On line inspections and functional tests are in place to prevent this type of damage from leaving the facility.The customer complaint was confirmed.The root cause of the damage on pebax cannot be determined 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 root cause of the t bar slippage and the damage observed on the peek housing tip transition cannot be determined, however, an internal corrective action has been opened to investigate.Manufacturer¿s reference number: (b)(4).

Manufacturer Narrative

Initially, it was reported that the tip's rubber connecting part was torn.Therefore, blood flowed inside of the irrigation tip.The biosense webster inc.Product analysis lab received the device for evaluation on (b)(6)2019 and noted during the visual inspection that there was reddish material under the pebax sleeve.The peek housing was cracked at the transitional area approximately 1.6 cm from the distal tip.There was reddish material under the peek housing in the cracked transition.The pebax and peek housing returned conditions were assessed as not reportable.The catheter integrity was maintained and no internal components were exposed to the patient.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.Populated d10.Device available for evaluation?, d10.Is device returned to manufacturer? and d10.Date device returned to manufacturer.Manufacturer's ref.No: (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: 8211078
• MDR Text Key: 132566883
• Report Number: 2029046-2019-02512
• Device Sequence Number: 1
• Product Code: LPB
• UDI-Device Identifier: 10846835010183
• UDI-Public: 10846835010183
• 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,Followup
• Report Date: 12/06/2018

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 Expiration Date: 05/28/2019
• Device Catalogue Number: D134805
• Device Lot Number: 30061885L
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/04/2019
• Initial Date Manufacturer Received: 12/06/2018
• Initial Date FDA Received: 01/02/2019
• Supplement Dates Manufacturer Received: 01/04/2019; 01/24/2019
• Supplement Dates FDA Received: 01/23/2019; 02/20/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1