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

Catalog Number D133604IL

Device Problems Material Protrusion/Extrusion (2979); Positioning Problem (3009)

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

Event Date 10/19/2022

Event Type  malfunction  

Manufacturer Narrative

Initial reporter phone: (b)(6).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 pma # (b)(4).The bwi product analysis lab received the device for evaluation on 18-nov-2022.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 a premature ventricular contraction (pvc) ablation procedure with a thermocool® smart touch¿ electrophysiology catheter and there was electrode damage with sharp/rough edges observed.Initially it was reported that during the procedure, the catheter was unable to deflect or relax completely.A second device was used to complete the procedure.There was no adverse event reported on patient.The event was assessed as a not reportable deflection issue.The most likely consequence was an intraprocedural delay.The potential risk that it could cause or contribute to a serious injury or death was remote.Additional information was received on 16-nov-2022 stating that the tip of the ablation catheter was damaged during the process of entering the sheath and could not be bent.The tip damaged issue was assessed as not mdr reportable for a tip bent /tip twisted issue.The potential that it could cause or contribute to a death or serious injury, or other significant adverse event, was remote.Additional information was received on 23-nov-2022: the damage on the catheter tip did not result in wires/internal components being exposed.The damage on the catheter tip resulted in lifted or sharp rings.There was no resistance or difficulty during insertion or removal of the catheter.The catheter was not pre-shaped.The additional information describing the lifted or sharp rings was assessed as mdr reportable for electrode damaged with sharp/rough edges.Therefore, the awareness date for this reportable issue is (b)(6) 2022.

Manufacturer Narrative

It was reported that a patient underwent a premature ventricular contraction (pvc) ablation procedure with a thermocool® smart touch¿ electrophysiology catheter and there was electrode damage with sharp/rough edges observed.It was reported that during the procedure, the catheter was unable to deflect or relax completely.A second device was used to complete the procedure.There was no adverse event reported on patient.Additional information was received on 16-nov-2022 stating that the tip of the ablation catheter was damaged during the process of entering the sheath and could not be bent.Additional information was received on 23-nov-2022 stating the damage on the catheter tip did not result in wires/internal components being exposed.The damage on the catheter tip resulted in lifted or sharp rings.There was no resistance or difficulty during insertion or removal of the catheter.The catheter was not pre-shaped.The investigation was completed on 22-dec-2022.The device was returned to biosense webster (bwi) for evaluation.Visual inspection and deflection tests of the returned device were performed following bwi procedures.Visual analysis revealed the peek housing and electrode #2 was kinked, additionally, no exposed internal parts were observed, also a polyurethane (pu) base application between the electrodes was observed.A deflection test was performed and the curve was deflecting within specifications.No deflection issues were observed.A manufacturing record evaluation was performed for the finished device, and no internal action was found during the review.The issue reported by the customer was confirmed during the product investigation.The root cause of the kinked electrode could be related to when the device entered the sheath.Biosense webster¿s quality process ensures 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 ¿deflection issue¿.-investigation findings: stress problem identified (c0706) / investigation conclusions: cause not established (d15) / component code: electrode (g0201501) were selected as related to the customer¿s reported ¿ electrode damaged with sharp/rough edges¿.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 ; MX
• Manufacturer Contact: kate karberg ; 31 technology dr; irvine, CA 92618 ; 3035526892
• MDR Report Key: 15928843
• MDR Text Key: 307659362
• Report Number: 2029046-2022-03046
• 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
• Report Date: 01/13/2023

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: 06/19/2023
• Device Catalogue Number: D133604IL
• Device Lot Number: 30816280M
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/18/2022
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 11/23/2022
• Initial Date FDA Received: 12/06/2022
• Supplement Dates Manufacturer Received: 12/22/2022
• Supplement Dates FDA Received: 01/13/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/20/2022
• 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 SRO SHEATH; UNKNOWN BRAND CATHETER