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

Model Number D134802

Device Problems High Readings (2459); Contamination /Decontamination Problem (2895)

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

Event Date 09/12/2022

Event Type  malfunction  

Manufacturer Narrative

The bwi product analysis lab received the device for evaluation on (b)(6) 2022.The investigation was completed on (b)(6) 2022.A picture was received for evaluation following biosense webster's procedures.According to pictures provided by the customer, blood was observed inside the pebax; no external damages were observed on the pebax section.No other damages or anomalies were observed on it.The blood inside the pebax could be related to the high force issue, 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.A visual inspection and screening test of the returned device were performed following bwi procedures.Visual analysis revealed reddish material inside the pebax component.The device was connected to the carto 3 and no errors were observed, the blood inside the pebax could be related to the issue reported by the customer; however, this cannot be conclusively determined.Additionally, no temperature was observed on the generator due to a loss of electrical resistance from the cut to the tip creating the temperature issue.Additionally, a scanning electron microscope (sem) testing was performed on the pebax component and the results showed evidence of mechanical damage, and a hole on the surface.A manufacturing record evaluation was performed, and no internal action was found during the review.The issue reported by the customer was confirmed.The blood inside the pebax could be related to the issue reported by the customer; however, this cannot be conclusively determined.The instructions for use (ifu) contain the following recommendations: to ensure accurate force readings, verify that the force reading is near zero when the catheter is not in contact with tissue.If the force reading is not near zero when the catheter is not in contact with tissue, perform zeroing.If the force 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.This product issue will be addressed through bwi's quality system.-explanation of codes: -investigation findings: appropriate term/code not available (c22) / investigation conclusions: cause not established (d15) were selected as related to the picture provided.-investigation findings: mechanical problem identified (c07) / investigation conclusions: cause not established (d15 / component code: sleeve (g04115) were selected as related to the customer¿s reported ¿high force¿ issue and ¿foreign material inside the pebax¿ issue.In addition to the biosense webster inc.Product analysis lab observed "foreign material inside the pebax with external damage" issue.-investigation findings: open circuit (c0205) / investigation conclusions cause not established (d15) / component code: electrical lead/wire (g02015) were selected as related to the biosense webster, inc.Product analysis lab observed ¿loss of electrical resistance from the cut to the tip creating the temperature issue¿.Manufacturer's reference number: (b)(4).

Event Description

It was reported that a patient underwent a procedure with a thermocool® smart touch® sf bi-directional navigation catheter and the biosense webster, inc.Product analysis lab observed foreign material inside the pebax with external damage.Initially it was reported that the contact force readings spiked to a high reading when they went on to ablate.The catheter was exchanged and the issue was resolved.The procedure was completed.After the procedure, they inspected the catheter and saw blood inside the contact force sensor housing.There was no patient consequence reported.Additional information was received.The sheath used was the vizigo 8.5 f.No difficulty maneuvering the catheter was reported by the physician.The caller was unable to confirm if there was physical damage.A picture was provided.The high force reading was assessed as not mdr 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 reported blood inside the contact force sensor housing was assessed as not 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 biosense webster, inc.Product analysis lab received the device for evaluation and per the evaluation completion on (b)(6) 2022 the visual analysis revealed reddish material inside the pebax component.A scanning electron microscope (sem) testing was performed on the pebax component, and the results showed evidence of mechanical damage and a hole on the surface.The hole on the pebax surface was assessed as mdr reportable for foreign material inside the pebax with external damage.The awareness date for this reportable lab finding was (b)(6) 2022.

• 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 ; MX
• Manufacturer Contact: kate karberg ; 31 technology dr; irvine, CA 92618 ; 3035526892
• MDR Report Key: 15950837
• MDR Text Key: 308274268
• Report Number: 2029046-2022-03075
• Device Sequence Number: 1
• Product Code: LPB
• UDI-Device Identifier: 10846835010152
• UDI-Public: 10846835010152
• 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: 12/09/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/09/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: D134802
• Device Catalogue Number: D134802
• Device Lot Number: 30851126L
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/24/2022
• Date Manufacturer Received: 11/11/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/14/2022
• 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 VIZIGO SHEATH