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); Contamination /Decontamination Problem (2895)

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

Event Date 05/31/2023

Event Type  malfunction  

Event Description

It was reported that a patient underwent an 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 hole with reddish material in the pebax area.It was initially reported by the customer that during the operation, the signal interference (noise) was observed on ic, bs, or all ecg (bs + ic) channels at the time of ablation.After removing the catheter from the patient, it seemed that blood was penetrated into the spring part of the device.A second device was used to complete the operation.There was no adverse event reported on patient.Additional information received indicated a swartz sheath was used and there was no difficulty withdrawing the catheter.There was no physical damage to the catheter.The noise was on the intracardiac signals while the catheter was in the body.The noise was seen on the carto 3 system and the physician did have another ecg signals available to monitor the patient¿s heart rhythm.The customer¿s reported noise issue is not considered to be mdr reportable since the risk to the patient is low.On 7-aug-2023, the bwi pal revealed that a visual inspection of the returned device found a hole with reddish material in the pebax area.These findings were reviewed and assessed the issue of a ¿hole¿ in the pebax as an mdr reporable malfunction 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 and electrical test of the returned device were performed following bwi procedures.Visual analysis revealed a hole with reddish material in the pebax area.No other damage was found.An electrical test was performed, and no electrical issues were found.The reddish material inside the pebax could be related to the electrical issue reported in the event.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 product failure is multifactorial.As part of biosense webster's quality process, all devices are manufactured, inspected, and released to approved specifications.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 (IRVINE); 33 technology drive; irvine CA 92618
• Manufacturer Contact: kate karberg ; 31 technology dr; irvine, CA 92618 ; 3035526892
• MDR Report Key: 17667490
• MDR Text Key: 322530274
• Report Number: 2029046-2023-01976
• 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: 08/31/2023

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 Expiration Date: 03/01/2024
• Device Catalogue Number: D134721IL
• Device Lot Number: 31002406L
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/10/2023
• Initial Date Manufacturer Received: 08/07/2023
• Initial Date FDA Received: 08/31/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/02/2023
• 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: CARTO 3 SYSTEM; SWARTZ SHEATH