MAUDE Adverse Event Report: MEDTRONIC IRELAND FLEXCATH CONTOUR¿ STEERABLE SHEATH; CATHETER, STEERABLE

Model Number	10FCC20
Medical Device Problem Codes	Gas/Air Leak (2946); Material Twisted/Bent (2981)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/04/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during an radiofrequency (rf) procedure, the sidearm was kinked. it was further reported that air bubbles were observed by the physician.The case was completed with radiofrequency. no patient complications have been reported as a result of this event.
Additional Manufacturer Narrative
Product event summary: the 10fcc20 sheath with lot number 0012149956 was returned and analyzed.Visual inspection of the sheath was performed and the inspection identified a kink at the side port tube.The tip of the sheath was intact with no anomaly.The steering mechanism and deflection test were performed and no anomaly was discovered.The lab test dilator was inserted into the sheath and retracted several times, without any friction.The lab test dilator was snap-locked to the sheath and was tight.Visual inspection and magnifying with a high-resolution microscope showed the valve housing was intact without any issue.The performance test with sentinel blackbelt leak tester was performed.The pressure test with 45 pounds per square inch gauge (psig) showed the pressure decay in the device was 0.069 psig and in an acceptable range.The vacuum test with a negative pressure of 8.5 psig showed the pressure decay in the device was 0.009 psig and in an acceptable range.In conclusion, the air ingress issue was not reproduced during analysis, however the side port kink was confirmed.The sheath failed the returned product inspection due to a kink on the side port tube.Medtronic submits this report to comply with fda regulations 21 cfr parts 4 and 803.Medtronic has made reasonable efforts to provide as much relevant information as is available to the company as of the submission date of this report.This report does not constitute an admission or a conclusion by fda, medtronic, or its employees that the device, medtronic, or its employee caused or contributed to the event described in the report.Any required fields that are unpopulated are blank because the information is currently unknown or unavailable.Medtronic will submit a supplemental report if additional relevant information becomes known.

• Brand Name: FLEXCATH CONTOUR¿ STEERABLE SHEATH
• Common Device Name: CATHETER, STEERABLE
• Manufacturer (Section D): MEDTRONIC IRELAND; parkmore business park west; galway ; EI
• Manufacturer (Section G): MEDTRONIC IRELAND; parkmore business park west; galway ; EI
• Manufacturer Contact: alison sweeney ; parkmore business park west; galway ; EI ; 091708096
• MDR Report Key: 19351041
• Report Number: 9612164-2024-02401
• Device Sequence Number: 12582975
• Product Code: DRA
• UDI-Device Identifier: 00763000659097
• UDI-Public: 00763000659097
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• PMA/510(K) Number: K232321
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 05/20/2024

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: 02/14/2026
• Device Model Number: 10FCC20
• Device Catalogue Number: 10FCC20
• Device Lot Number: 0012149956
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/15/2024
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/25/2024
• Initial Report FDA Received Date: 05/20/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/15/2024
• 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
• Patient Sex: Female