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

Catalog Number D134721IL

Device Problems Signal Artifact/Noise (1036); Incorrect, Inadequate or Imprecise Result or Readings (1535)

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

Event Date 06/29/2023

Event Type  malfunction  

Event Description

It was reported that a patient underwent a paroxysmal atrial fibrillation (afib) ablation procedure with a thermocool® smart touch® sf uni-directional navigation catheter for which biosense webster¿s product analysis lab (pal) identified a reddish material and a hole in the surface of the pebax and a foreign material was found attached under electrode #2.It was initially reported by the customer that during the operation, there was a problem with the force of the catheter.A second device was used to complete the operation.There was no adverse event reported on patient.The customer¿s reported force issue is not considered to be mdr reportable since the potential risk that it could cause or contribute to a serious injury or death to the operator or patient is remote.On 8-aug-2023, the bwi pal revealed that a visual inspection of the returned device found a reddish material and a hole in the surface of the pebax.Additionally, during the visual inspection, a blue foreign material was found attached under electrode #2.These findings were reviewed and assessed as mdr reportable malfunctions since the integrity of the device has been compromised.

Manufacturer Narrative

Device evaluation details: the device was returned to biosense webster inc (bwi) for evaluation and the evaluation has been completed.Visual inspection, screening and electrical test of the returned device were performed following bwi procedures.Visual analysis revealed reddish material and a hole in the surface of the pebax.Additionally, during the visual inspection, a blue foreign material was found attached under electrode #2.The magnetic and force feature were tested, and no errors were observed.The force values and the vector were observed within specifications.No force issues were observed.Afterward, an electrical test was performed, and the results were found within specifications, no noise issues were observed.Since a blue foreign material was detected, a fourier-transform infrared spectroscopy (ft-ir) analysis was requested, and it was revealed that the blue particle exhibited a coincidence match with the shaft material, these components are made based nylon-pebax materials depending on the part number, also shared the blue coloration; however, this component can be pinpointed as potential source of the origin of this blue particle.Additionally, according to pictures provided by the customer, hi (high force value) message was observed on the carto 3 screen.Also, a signal noise was observed on the carto 3 screen.A manufacturing record evaluation was performed for the finished device batch number, and no internal actions were identified.The reddish material inside the pebax could be related to the force and noise issues reported; therefore, the customer complaint was confirmed.The root cause of the pebax damage could be related to the manipulation of the device during the procedure; however, this cannot be conclusively determined.As part of biosense webster¿s quality process, all devices are manufactured, inspected, and released to approved specifications.Explanation of codes: investigation findings: inappropriate material (c0602) / investigation conclusions: unintended use error caused or contributed to event (d1102) / component code: electrode (g0201501) were selected as related to the issue of foreign material under electrode 2.Investigation findings: mechanical problem identified (c07) / investigation conclusions: no problem detected (d14) / component code: sleeve (g04115) were selected as related to the hole in the pebax.E1.Initial reporter phone: (b)(6).If additional information is received regarding this event, a supplemental 3500a report will be submitted to the fda.Manufacturer's ref.# (b)(4).

• Brand Name: THERMOCOOL® SMART TOUCH® SF UNI-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: 17687812
• MDR Text Key: 322722276
• Report Number: 2029046-2023-02000
• Device Sequence Number: 1
• Product Code: LPB
• Combination Product (y/n): N
• Reporter Country Code: CH
• PMA/PMN Number: P030031/S053
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 09/05/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/05/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 03/30/2024
• Device Catalogue Number: D134721IL
• Device Lot Number: 31029819L
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/24/2023
• Date Manufacturer Received: 08/08/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/31/2023
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1