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

Catalog Number D133604IL

Device Problems Break (1069); Detachment of Device or Device Component (2907)

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

Event Date 02/21/2023

Event Type  malfunction  

Manufacturer Narrative

The ¿suspected medical device¿ reported in section d of this report is not marketed in usa or approved by the fda.However, it is being reported as biosense webster considers this as a similar device to thermocool® smart touch¿ electrophysiology catheter approved under p030031/s053.The bwi product analysis lab received the device for evaluation on 13-mar-2023.The analysis has begun but is not completed at this time.When the investigational analysis has been completed, a supplemental 3500a report will be submitted.If additional information is received regarding this event, a supplemental 3500a report will be submitted to the fda.This report is being submitted pursuant to the provisions of 21 cfr, part 803.This report may be based on information which has not been investigated or verified prior to the required reporting date.This report does not reflect a conclusion by biosense webster, inc., or its employees that the report constitutes an admission that the product, biosense webster, inc., or its employees caused or contributed to the potential event described in this report.If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.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¿ electrophysiology catheter and a broken tip issue occurred.The device was damaged.During the procedure, the tip of the device was damaged (with wire exposed) when using on the patient normally.A second device was used to complete the procedure.No patient consequence was reported.Additional information was received.The damage did not result in any lifted or sharp rings.There was no resistance or difficulty during insertion or removal of the catheter.It was unknown how far the issue was found from the distal end of the catheter.The catheter was not pre-shaped.The abbott 8.5f sheath was used.The event was assessed as mdr reportable for a broken tip issue.

Manufacturer Narrative

It was reported that a patient underwent an atrial fibrillation (afib) procedure with a thermocool® smart touch¿ electrophysiology catheter and a broken tip issue occurred.The device was damaged.During the procedure, the tip of the device was damaged (with wire exposed) when using on the patient normally.A second device was used to complete the procedure.No patient consequence was reported.Additional information was received.The problem occurred at the tip and when replacing the catheter, the surgeon accidentally unplugged the connector.The device evaluation was completed on 19-may-2023.The product was returned to biosense webster (bwi) for evaluation.A visual inspection of the returned device was performed following bwi procedures.Visual analysis showed that there was no damage found in the tip section; however, the connector was found detached from the handle with the internal wires exposed.Further examination determined that there was a lack of adhesive on the connector.For this reason, a manufacturing investigation was performed, and concluded that this issue is related to the manufacturing process.Additionally, no other catheters from this lot have been reported with a similar issue.Therefore, an awareness session was performed to the involved personnel.A manufacturing record evaluation was performed for the finished device batch number, and no internal actions were identified.The connector issue reported by the customer was 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.Explanation of codes: -investigation findings: no device problem found (c19)/ investigation conclusions: no problem detected (d14) were selected as related to the customer¿s reported ¿broken tip¿ issue.-investigation findings: manufacturing process problem identified (c16) / investigation conclusions: cause traced to manufacturing (d03) / component code: connector/coupler (g04034) were selected as related to the customer¿s reported ¿connector came out¿ issue.If additional information is received regarding this event, a supplemental 3500a report will be submitted to the fda.Manufacturer's reference number: (b)(4).

Manufacturer Narrative

Additional information was received on 05-may-2023.The problem actually occurred at the tip and when replacing the catheter, the surgeon accidentally unplugged the connector.Therefore, the additional issue of the connector was assessed as non mdr reportable for a connector came out issue.Since the device or the cable have the connector detached or broken, the device can not be used.The most likely consequence was an intraprocedural delay.The potential that it could cause or contribute to a death or serious injury, or other significant adverse event, was remote.The risk to the patient was remote.Hence, added under h6.Medical device problem code "detachment of device or device component (a0501)".Additional information was received on 30-may-2023.The damage on the tip did not result in wires being exposed.No picture is available.Requesting clarification on the actual issue of the tip as there was a discrepancy on the information provided.The reported event states, "the tip of the device was damaged (with wire exposed)" and additional information received on 05-may-2023 states, "problem actually occurs at the tip"; however, additional information received on 30-may-2023 states, "the damage on the tip did not result in wires being exposed.If additional information is received regarding this event, a supplemental 3500a report will be submitted to the fda.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 32599 ; MX 32599
• Manufacturer Contact: kate karberg ; 31 technology dr; irvine, CA 92618 ; 3035526892
• MDR Report Key: 16592947
• MDR Text Key: 312289295
• Report Number: 2029046-2023-00599
• 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,Followup,Followup
• Report Date: 06/15/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/22/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 07/06/2023
• Device Catalogue Number: D133604IL
• Device Lot Number: 30845204M
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/13/2023
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 06/15/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/07/2022
• 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: NON BWI-ABBOTT 8.5 SHEATH.; UNKNOWN BRAND CATHETER.