MAUDE Adverse Event Report: BIOSENSE WEBSTER INC THERMOCOOL® SMART TOUCH® SF UNI-DIRECTIONAL NAVIGATION CATHETER; SIMILAR DEVICE D133601, PMA # P030031/S053

Catalog Number D134721IL

Device Problems Failure to Sense (1559); Detachment of Device or Device Component (2907)

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

Event Date 08/24/2021

Event Type  malfunction  

Event Description

It was reported that a patient underwent a premature ventricular contraction (pvc) procedure with a thermocool® smart touch® sf uni-directional navigation catheter and the biosense webster, inc.Product analysis lab observed a broken tip with exposed wires.Initially a force sensor error was reported.During the procedure, error 106 was displayed on the carto system.A second catheter was used to complete the procedure.There was no patient consequence reported.Since the warning of "error 106" functioned as intended, this event was assessed as not mdr reportable.The biosense webster, inc.Product analysis lab received the device for evaluation and per the evaluation completion on 19-nov-2021 a broken tip with exposed wires was observed.Multiple attempts have been made to obtain clarification to this returned condition.However, no further information has been made available.With the information available, the returned condition of broken tip with exposed wires was assessed as mdr reportable.The awareness date for this reportable lab finding was 19-nov-2021.

Manufacturer Narrative

Initial reporter phone: (b)(6).Additional clarification has been requested.Initial reporter facility name.If additional information is received, a supplemental 3500a report will be submitted to the fda.The bwi product analysis lab received the device for evaluation on 22-sep-2021.The device evaluation was completed on 19-nov-2021.The product was returned to biosense webster for evaluation.Bwi then conducted a visual inspection and functional analysis of the returned device.Visual analysis of the returned device revealed a broken tip with exposed wires of the smart touch unidirectional sf.The functional test was performed, in accordance with bwi procedures.Despite of the device damage, the catheter was connected to carto 3 and recognized; but 106 was displayed on the screen.The failure observed during the testing could be related with the tip damage; however, the sample was not tested in the same conditions that the customer used since this tip damage was not initially reported.Therefore, no other testing or verification could not be performed due to the tip damage.The damage could have occurred during the shipping process since the customer did not confirm this issue.A manufacturing record evaluation was performed and no internal actions related to the reported complaint were identified.As part of bwi¿s quality process, all devices are manufactured, inspected, and released to approved specifications.It should be noted that product failure is multifactorial.The instructions for use contain the following warning stated in the carto 3 system manual: the force sensor of the catheter is disconnected.If the problem persists, replace the catheter cable or the catheter.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 16-dec-2021 providing the facility name.Therefore, updated e.Initial reporter section.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 reference number: (b)(4) correction to "e1.Initial reporter address line 1" field.

• Brand Name: THERMOCOOL® SMART TOUCH® SF UNI-DIRECTIONAL NAVIGATION 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: gabriel alfageme ; 31 technology dr; irvine, CA 92618 ; 9497898687
• MDR Report Key: 13014800
• MDR Text Key: 287582897
• Report Number: 2029046-2021-02169
• 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,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 12/19/2021

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: 04/08/2022
• Device Catalogue Number: D134721IL
• Device Lot Number: 30523211L
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/22/2021
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 11/19/2021
• Initial Date FDA Received: 12/15/2021
• Supplement Dates Manufacturer Received: 12/16/2021
• Supplement Dates FDA Received: 12/19/2021
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/09/2021
• 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: UNKNOWN BRAND CATHETER; UNK_CARTO 3