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

Model Number 10FCC20

Device Problems Gas/Air Leak (2946); Material Twisted/Bent (2981)

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

Event Date 04/01/2024

Event Type  malfunction  

Event Description

It was reported that during a pulsed field ablation, air bubbles were noted in side arm during catheter removal and insertion and bubbles seen during aspiration of side arm with catheter in the sheath.The case was completed with pulsed field ablation.No patient complications have been reported as a result of this event.

Manufacturer Narrative

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.

Manufacturer Narrative

Product event summary: the 10fcc20 sheath with lot number 0012130403 was returned and analyzed.Visual inspection of the sheath was performed and 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 0.066 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 0.014 psig and in an acceptable range.In conclusion, the air ingress issue was not reproduced during analysis.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
• Type of Device: 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: 19017683
• MDR Text Key: 339231882
• Report Number: 9612164-2024-01542
• Device Sequence Number: 1
• Product Code: DRA
• UDI-Device Identifier: 00763000659097
• UDI-Public: 00763000659097
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K232321
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 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
• Device Operator: Health Professional
• Device Model Number: 10FCC20
• Device Catalogue Number: 10FCC20
• Device Lot Number: 0012130403
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 04/01/2024
• Initial Date FDA Received: 04/02/2024
• Supplement Dates Manufacturer Received: 04/29/2024
• Supplement Dates FDA Received: 05/20/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/01/2024
• 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
• Patient Sex: Male