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

Model Number D134804

Device Problems Erratic or Intermittent Display (1182); Contamination /Decontamination Problem (2895)

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

Event Date 04/12/2023

Event Type  malfunction  

Manufacturer Narrative

The investigation was completed on (b)(6) 2023.A picture was received for evaluation following biosense webster's procedures.According to pictures provided by the customer, reddish material was observed inside the pebax; however, no external damages were observed on this section.Although there is no evidence of the icon jumping condition reported by the customer, the reddish material inside the pebax, could be related to the reported condition; however, this cannot be conclusively determined.The customer complaint was confirmed based on the picture received.The product analysis was performed as appropriate in order to find the root cause of the complaint.The device was returned to biosense webster (bwi) for evaluation.Visual inspection and a magnetic sensor functionality test of the returned device were performed following bwi procedures.Visual analysis revealed that there was a reddish material and a cut on the pebax surface leaving internal parts exposed.The device was connected to the carto 3 system and it was visualized and recognized correctly; additionally, an ablation test was performed and no issues were observed during the analysis.The reddish material observed during the analysis could cause the visualization issue reported by the customer, however, this could not be conclusively determined.A manufacturing record evaluation was performed for the finished device number, and no internal actions related to the reported complaint condition were identified.The issues reported by the customer were confirmed.It should be noted that device failure is multifactorial.The instructions for use contain the following recommendations stated in the carto 3 system manual: the magnetic sensor of the catheter is disconnected.If the problem persists, replace the catheter cable or the catheter.As part of biosense webster¿s quality process, all devices are manufactured, inspected, and released to approved specifications.Explanation of codes: picture evaluation: investigation findings: appropriate term/code not available (c22); operational problem identified (c13)/ investigation conclusions: cause not established (d15)/ component code: sleeve (g04115) were selected as related to the picture provided and the customer¿s reported ¿icon jumping¿; ¿foreign material inside the pebax with no external damage issues¿.Device evaluation: investigation findings: mechanical problem identified (c07) / investigation conclusions: cause not established (d15) / component code: sleeve (g04115) were selected as related to the biosense webster inc.Analysis finding of the ¿foreign material inside the pebax with external damage¿ issue and the customer¿s reported ¿icon jumping¿; ¿foreign material inside the pebax with no external damage issues¿.Manufacturer's reference number: (b(4).

Event Description

It was reported that a patient underwent an atrial fibrillation (afib) procedure with a thermocool® smart touch® sf bi-directional navigation catheter for which biosense webster¿s product analysis lab (pal) identified the cut on the pebax surface leaving internal parts exposed.It was reported that the thermocool® smart touch® sf bi-directional navigation catheter started flying around the screen randomly outside of the map on the carto 3 system.When the catheter was removed from the body, they noticed the tip was broken.When the catheter was replaced, the issue resolved.Additional information was received.The damage did not result in wires being exposed.The damage did not result in any lifted or sharp rings.There was no resistance or difficulty during insertion or removal of the catheter.The issue was found around the spring.The catheter was not pre-shaped.The issue found around the spring was assessed as non mdr reportable for foreign material inside the pebax with no external damage.The potential that it could cause or contribute to a death or serious injury, or other significant adverse event, was remote.The issue reported of the thermocool® smart touch® sf bi-directional navigation catheter flying around the screen randomly outside of the map on the carto 3 system was assessed as non mdr reportable for icon jumping.The catheter icon jumping was a highly detectable issue.There was no real movement of the catheter.The most likely consequence was an intraprocedural delay.The potential risk that it could cause or contribute to a serious injury or death was remote.The biosense webster, inc.Product analysis lab received the device for evaluation and per the evaluation completion on 18-may-2023, there was reddish material and a cut on the pebax surface leaving internal parts exposed.The cut on the pebax surface leaving internal parts exposed was assessed as mdr reportable.The awareness date for this reportable lab finding was 18-may-2023.

• Brand Name: THERMOCOOL® SMART TOUCH® SF BI-DIRECTIONAL NAVIGATION CATHETER
• Type of Device: CARDIAC ABLATION PERCUTANEOUS CATHETER
• Manufacturer (Section D): BIOSENSE WEBSTER INC; 31 technology drive, suite 200; irvine CA 92618
• Manufacturer (Section G): BIOSENSE WEBSTER INC (JUAREZ); circuito interior norte; 1820parque industrial salvacar; juarez 32599 ; MX 32599
• Manufacturer Contact: kate karberg ; 31 technology dr; irvine, CA 92618 ; 3035526892
• MDR Report Key: 17109386
• MDR Text Key: 317780934
• Report Number: 2029046-2023-01268
• Device Sequence Number: 1
• Product Code: LPB
• UDI-Device Identifier: 10846835010176
• UDI-Public: 10846835010176
• 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: Health Professional,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 06/12/2023

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 Model Number: D134804
• Device Catalogue Number: D134804
• Device Lot Number: 30986086L
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/11/2023
• Initial Date Manufacturer Received: 05/18/2023
• Initial Date FDA Received: 06/12/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/31/2023
• 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
• Treatment: UNKNOWN BRAND CATHETER; UNK_CARTO 3