MAUDE Adverse Event Report: BIOSENSE WEBSTER INC THERMOCOOL® SF BI-DIRECTIONAL CATHETER; CARDIAC ABLATION PERCUTANEOUS CATHETER

Model Number	BDI35DFRT
Medical Device Problem Codes	Break (1069); Positioning Problem (3009)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/19/2021
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that an unknown patient underwent an unknown ablation procedure with a thermocool® sf bi-directional catheter.The tip was broken.The tip of the catheter was broken on intra-op.It's normal that the catheter has bi-directional curves (d/f), but one of the curves was broken during the procedure, so the physician could not manipulate the catheter properly.The physician requested to change the catheter.The catheter was replaced with new one, and it has curved well without any curve problem.After using new catheter, the procedure has successfully done.No wire was exposed and no lifting or sharp rings occurred.There was no reported resistance or difficulty during insertion or removal of the catheter.It was not a pre-shaped.Sheath was an agilis, 8.5f.Deflection issue is not mdr-reportable.Broken tip is mdr-reportable.
Additional Manufacturer Narrative
If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.If additional information is received regarding this event, a supplemental 3500a report will be submitted to the fda.(b)(4).
Additional Manufacturer Narrative
On 18-nov-2021, the bwi product analysis lab received the device for evaluation.The product investigation was subsequently completed.It was reported that an unknown patient underwent an unknown ablation procedure with a thermocool® sf bi-directional catheter.The tip was broken.The tip of the catheter was broken on intra-op.It's normal that the catheter has bi-directional curves (d/f), but one of the curves was broken during the procedure, so the physician could not manipulate the catheter properly.The physician requested to change the catheter.The catheter was replaced with new one, and it has curved well without any curve problem.After using new catheter, the procedure has successfully done.Device evaluation details: visual analysis of the returned sample revealed that no damage or anomalies were observed on the thermocool sf catheter.A deflection test was performed and it was found within specifications, the catheter was deflecting correctly.A manufacturing record evaluation was performed for the finished device [30584764l] number, and no internal actions related to the reported complaint condition were identified.No deflection or other issues were verified during the analysis.The instructions for use contain the following recommendations: inspect all components before use.The event described could not be confirmed as the device performed without any deflection issues.Although no product defect was identified, there may have been other circumstances or issues that occurred during the use of the device that could not be replicated during the laboratory analysis.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® SF BI-DIRECTIONAL CATHETER
• Common Device Name: CARDIAC ABLATION PERCUTANEOUS CATHETER
• 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: gabriel alfageme ; 31 technology dr; irvine, CA 92618 ; 9497898687
• MDR Report Key: 12777047
• Report Number: 2029046-2021-01915
• Device Sequence Number: 3459372
• Product Code: LPB
• UDI-Device Identifier: 10846835002812
• UDI-Public: 10846835002812
• Combination Product (Y/N): N
• Initial Reporter Country: KS
• PMA/510(K) Number: P030031/S025
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 12/07/2021

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
• Operator of Device: Health Professional
• Device Expiration Date: 06/30/2024
• Device Model Number: BDI35DFRT
• Device Catalogue Number: BDI35DFRT
• Device Lot Number: 30584764L
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/18/2021
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/19/2021
• Supplement Date Received by Manufacturer: 11/18/2021
• Initial Report FDA Received Date: 11/09/2021
• Supplement Report FDA Received Date: 12/07/2021
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/01/2021
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: AGILIS SHEATH
• Patient Sex: Unknown