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

Model Number D134805

Device Problems Material Puncture/Hole (1504); Sharp Edges (4013)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 01/07/2020

Event Type  malfunction  

Manufacturer Narrative

Investigation summary: the device was visually inspected and it was found electrode damage, electrical wire exposed and an hole in pebax with reddish material.Then, magnetic sensor functionality was tested on carto and the catheter failed, hi error 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 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 electrode, wire exposed and hole in 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 atrial flutter right (r-afl) procedure with thermocool® smart touch® sf bi-directional navigation catheter and the biosense webster, inc.Product analysis lab observed an electrode lifted with an electrode wire exposed and a hole on the pebax with reddish material inside.It was reported that the catheter was showing an abnormally high contact force value while ablating on the carto 3 system.The catheter was replaced and the issue resolved.No patient consequence was reported.The high force was assessed as not reportable.The issue was highly detectable when occurring.The potential that it could cause or contribute to a death, serious injury, or other significant adverse event was low.The biosense webster, inc.Product analysis lab received the catheter for evaluation and noted on january 24, 2020 that an internal wire appeared exposed slightly protruding approximately.5 cm from distal tip.During further analysis on january 31, 2020, it was clarified that an electrode was observed lifted with an electrode wire exposed.In addition, a hole was observed on the pebax with reddish material inside.The electrode lifted with a wire exposed was assessed as a reportable issue and the awareness date for this finding is january 24, 2020.In addition, the hole on the pebax was assessed as a reportable issue and the awareness date for this issue is january 31, 2020.

• 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: 9736294
• MDR Text Key: 200455804
• Report Number: 2029046-2020-00276
• 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: 01/07/2020

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: 08/26/2020
• Device Model Number: D134805
• Device Catalogue Number: D134805
• Device Lot Number: 30269834M
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/24/2020
• Initial Date Manufacturer Received: 01/24/2020
• Initial Date FDA Received: 02/20/2020
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/27/2019
• 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