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

Catalog Number D134702

Device Problems Material Discolored (1170); Tear, Rip or Hole in Device Packaging (2385); Structural Problem (2506)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 10/10/2019

Event Type  malfunction  

Manufacturer Narrative

The investigational analysis completed (b)(6) 2019.The device was inspected, and pebax sleeve was found with reddish-brown material inside.No signs of damage to the sleeve was observed.During the second visual, the reddish-brown material inside the pebax was confirmed.Additionally, a hole on pebax exposing internal parts was observed.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.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 with a thermocool® smart touch® sf uni-directional navigation catheter, and the biosense webster inc.(bwi) product analysis lab (pal) found a hole in the pebax.Initially, it was reported that force read high when coming on ablation.The catheter cable was replaced, but the issue remained.Catheter replacement resolved the issue.No adverse patient consequences were reported.The observed high force 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 (b)(6) 2019, the bwi pal received the device for evaluation.Upon initial inspection, the pebax sleeve was observed with reddish material inside.There were no signs of damage to the sleeve observed.However, further testing was performed.During a second visual inspection on (b)(6) 2019, reddish brown material was observed in the pebax with a hole.The observed hole in the pebax has been assessed as an mdr reportable malfunction as internal parts were exposed.The awareness date has been reset to (b)(6) 2019.

• Brand Name: THERMOCOOL® SMART TOUCH® SF UNI-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: 9492566
• MDR Text Key: 199724714
• Report Number: 2029046-2019-04028
• Device Sequence Number: 1
• Product Code: LPB
• UDI-Device Identifier: 10846835009781
• UDI-Public: 10846835009781
• 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: 10/10/2019

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: 07/08/2020
• Device Catalogue Number: D134702
• Device Lot Number: 30252081M
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/24/2019
• Initial Date Manufacturer Received: 11/21/2019
• Initial Date FDA Received: 12/19/2019
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/09/2019
• 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