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

Catalog Number D134804

Device Problem Tear, Rip or Hole in Device Packaging (2385)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 11/18/2019

Event Type  malfunction  

Manufacturer Narrative

The biosense webster inc.Product analysis lab received the device for evaluation.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.(b)(4).

Event Description

It was reported that a patient underwent an ablation procedure with a thermocool® smart touch® sf bi-directional navigation catheter, and the biosense webster inc.(bwi) product analysis lab (pal) found a hole on the pebax surface.Initially, it was reported that the carto 3 system was displaying a force sensor error 106 when the catheter was plugged into the patient interface unit.The catheter cable was replaced and the issue remained.The catheter was replaced and the issue resolved.No adverse patient consequences were reported.The observed force sensor error has been assessed as not mdr reportable.The potential that it could cause or contribute to a death or serious injury, or other significant adverse event, is remote.On 12/3/2019, the bwi pal received the device for evaluation.Upon initial inspection, reddish brown material was found inside the pebax sleeve.The observed reddish-brown material has been assessed as not mdr reportable.The potential that it could cause or contribute to a death or serious injury, or other significant adverse event, is remote.Further testing was performed.During a second visual inspection on 12/20/2019, the bwi pal observed a hole in the pebax sleeve.The observed hole has been assessed as an mdr reportable malfunction, as the device integrity was compromised.The awareness date has been reset to 12/20/2019.

Manufacturer Narrative

The investigational analysis completed 1/15/2020.The device was visually inspected and reddish- brown material was found in the pebax sleeve.During the second visual, reddish-brown material was confirmed in the pebax.Additionally a hole was found.O the magnetic sensor functionality was tested on carto and the catheter failed.Error 105 was 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 actions 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.Manufacture reference 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: 9591302
• MDR Text Key: 200068305
• Report Number: 2029046-2020-00073
• 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
• Report Date: 01/15/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/15/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 08/13/2020
• Device Catalogue Number: D134804
• Device Lot Number: 30273699M
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 01/15/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: CARTO 3 SYSTEM