MAUDE Adverse Event Report: BIOSENSE WEBSTER INC THERMOCOOL® SMART TOUCH¿ ELECTROPHYSIOLOGY CATHETER; SIMILAR DEVICE D133601, PMA # P030031/S053

Catalog Number D133604IL

Device Problem High Readings (2459)

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

Event Date 08/12/2022

Event Type  malfunction  

Event Description

It was reported that a patient underwent a procedure with a thermocool® smart touch¿ electrophysiology catheter and the biosense webster¿s inc.Product analysis lab observed a hole on the pebax surface.Initially it was reported that during procedure, the force values displayed were high.A second device was used to complete the procedure.There was no adverse event reported on the patient.The force high issue 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 biosense webster, inc.Product analysis lab received the device for evaluation and per the evaluation completion on (b)(6) 2022, there was reddish material found on the pebax.A scanning electron microscope (sem) testing was performed on the pebax area and the results showed evidence of mechanical damage, and a hole on the pebax surface.The hole on the pebax surface was assessed as mdr reportable.The awareness date for this reportable lab finding was (b)(6) 2022.

Manufacturer Narrative

The bwi product analysis lab received the device for evaluation on (b)(6) 2022.The device evaluation was completed on (b)(6) 2022.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.A screening test was performed and the high force was observed due to an internal issue on the printed circuit board (pcb).Additionally, a scanning electron microscope (sem) testing was performed on the pebax component.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.It should be noted that the pc board issue and the damage on the pebax are multifactorial.It could be related to the usage of the device during the procedure; 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: incompatible component/ accessory (c0402) / investigation conclusions: cause traced to component failure (d02) / component code: circuit board (g02005) were selected as related to the customer¿s reported ¿force high¿ issue.Investigation findings: mechanical problem identified (c07) / investigation conclusions: cause not established (d15) / component code: sleeve (g04115) were selected as related to the biosense webster¿s inc.Product analysis lab observed issue of the ¿foreign material inside the pebax - external damage¿ and the customer¿s reported ¿force high¿ issue.Manufacturer's reference number: (b)(4).

• Brand Name: THERMOCOOL® SMART TOUCH¿ ELECTROPHYSIOLOGY CATHETER
• Type of Device: SIMILAR DEVICE D133601, PMA # P030031/S053
• 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: 15680609
• MDR Text Key: 307011743
• Report Number: 2029046-2022-02639
• Device Sequence Number: 1
• Product Code: LPB
• Combination Product (y/n): N
• Reporter Country Code: CH
• 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: 10/27/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/27/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 03/21/2023
• Device Catalogue Number: D133604IL
• Device Lot Number: 30750793M
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/21/2022
• Date Manufacturer Received: 09/28/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/22/2022
• 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