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

Catalog Number D134805

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

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 10/25/2019

Event Type  malfunction  

Manufacturer Narrative

The investigational analysis completed 12/23/2019.The device was visually inspected and reddish-brown material was observed under pebax.The magnetic sensor functionality was tested on carto and the catheter was properly visualized, with no errors observed.The force sensor feature was tested and it was found to be working properly.The force values were observed within specifications.Additionally, scanning electron microscope (sem) testing was performed on the pebax area.The results showed mechanical damage and a hole on the pebax surface.The object that caused the damage is unknown.No other anomalies were observed.A manufacturing record evaluation was performed and no internal actions were identified.The customer complaint cannot be confirmed.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.(b)(4).

Event Description

It was reported that a patient underwent an ablation procedure for atrial fibrillation with a thermocool® smart touch® sf bi-directional navigation catheter, and the biosense webster inc.(bwi) product analysis lab (pal) found a hole in the pebax surface.Initially, it was reported that when radio frequency energy was applied, high force readings were observed.The cable was changed without resolution.Catheter replacement resolved the issue.No adverse patient consequences were reported.The observed high force readings have 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 11/14/2019, the bwi pal received the device for evaluation.Upon initial inspection, reddish brown material was observed under the pebax.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.Scanning electron microscope (sem) analysis was then performed to further investigate the pebax condition.On 12/20/2019, sem was performed and the bwi pal observed mechanical damage and a hole on the pebax surface.The observed hole has been assessed as an mdr reportable malfunction, as device integrity was compromised.The awareness date has been reset to 12/20/2019.

• 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
• Manufacturer (Section G): BIOSENSE WEBSTER INC (JUAREZ); circuito interior norte; 1820parque industrial salvacar; juarez 32599 ; MX 32599
• Manufacturer Contact: gabriel alfageme ; 31 technology drive; irvine, CA 92618 ; 949789-868
• MDR Report Key: 9591246
• MDR Text Key: 200072322
• Report Number: 2029046-2020-00064
• Device Sequence Number: 1
• Product Code: LPB
• UDI-Device Identifier: 10846835010183
• UDI-Public: 10846835010183
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P030031
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 10/25/2019

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: 07/31/2020
• Device Catalogue Number: D134805
• Device Lot Number: 30262372M
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/14/2019
• Initial Date Manufacturer Received: 12/20/2019
• Initial Date FDA Received: 01/15/2020
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/01/2019
• 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