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

Model Number D134805

Device Problems Display or Visual Feedback Problem (1184); Material Puncture/Hole (1504); Failure to Sense (1559); Contamination /Decontamination Problem (2895)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 12/22/2020

Event Type  malfunction  

Manufacturer Narrative

Device investigation details: the device evaluation has been completed.The returned device was visually inspected and it was found with a reddish material and a hole in the pebax, internal part are exposed.Force sensor functionality was tested on carto 3 system and error 106 appeared.The tip area was dissected to perform the failure analysis, and an open circuit was found from the tip to the dome.A manufacturing record evaluation was performed, and no internal action related to the reported complaint condition were identified.The customer complaint it was confirmed, since the error 106 was displayed and the blood inside the pebax area found could be related to the reported issue.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.If additional information is received regarding this event, a supplemental 3500a report will be submitted to the fda.Manufacturer's ref.# pc-(b)(4).

Event Description

A patient underwent an ablation procedure with a thermocool® smart touch® sf bi-directional navigation catheter for which biosense webster¿s product analysis lab identified a hole on the pebax.It was initially reported by the customer that the thermocool® smart touch® sf bi-directional navigation catheter was unable to show any contact force readings.The caller stated that the thermocool® smart touch® sf bi-directional navigation catheter was unable to be re-zeroed and the arrow would start flicking.The cable was replaced without resolution.The catheter was replaced, and the issue was resolved.The procedure was continued.The caller stated that the catheter tip had blood in the coil.The customer reported visualization, force and foreign material are not considered to be mdr reportable since the issues are highly detectable when occurring.The potential that these could cause or contribute to a death, serious injury, or other significant adverse event is low.On 1/25/2021, the bwi product analysis lab received the complaint device for evaluation.On 2/11/2021, the complaint catheter was inspected and a reddish material was found inside the pebax and a hole in it.These findings were assessed as determined the issue of a ¿hole¿ in the pebax was assessed as an mdr reportable malfunction since the integrity of the device has been compromised.

• 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 dr; irvine, CA 92618 ; 9497898687
• MDR Report Key: 11468559
• MDR Text Key: 266247536
• Report Number: 2029046-2021-00356
• 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: 12/22/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/12/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 10/19/2021
• Device Model Number: D134805
• Device Catalogue Number: D134805
• Device Lot Number: 30452654M
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/25/2021
• Date Manufacturer Received: 02/11/2021
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/20/2020
• 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