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

Model Number 10FCC13

Device Problem Leak/Splash (1354)

Patient Problems Non specific EKG/ECG Changes (1817); Embolism/Embolus (4438); Heart Block (4444); Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Date 02/29/2024

Event Type  Injury  

Manufacturer Narrative

Continuation of d10: product id :pscc100 product type: pulsefield catheter 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.

Event Description

It was reported that during pulsed field ablation procedure, st elevation and heart block were observed for twenty minutes after placing the pulsed field ablation catheter into the left atrium.It was suspected by the physician to be caused by an air bubble.The symptoms resolved after twenty minutes.No intervention was carried out. the case was completed with pulsed field ablation. no further 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

Correction: updated imf code product event summary: the 10fcc13 steerable sheath of lot number 0012106995 and data files containing two images were returned and analyzed.Both photos showed microbubbles were observed in the side port tube of the sheath.Visual inspection of the handle area was performed.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.No anomaly was discovered.The lab test dilator was inserted into the steerable sheath and retracted several times, without any friction.The lab test dilator was snap-locked to the steerable 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 pounds per square inch gauge (psig) showed the pressure decay in the device was 0.063 psig and in an acceptable range (should be between -0.3 and 0.3 psig).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 (should be between -0.3 and 0.3 psig).In conclusion, the reported st elevation and heart block issue that occurred during the procedure and could not be confirmed through product analysis or data analysis.The reported air ingress was confirmed via the images provided in the analysis but could not be reproduced during product analysis.The steerable sheath failed the return product inspection due a kink was 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.

Event Description

It was reported that during pulsed field ablation procedure, st elevation and heart block were observed for twenty minutes after placing the pulsed field ablation catheter into the left atrium.It was suspected by the physician to be caused by an air bubble.The symptoms resolved after twenty minutes.No intervention was carried out. the case was completed with pulsed field ablation. no further patient complications have been reported as a result of this event.2024-05-13: it was later reported that the patient experienced third degree heart block.It was surmised that the adverse events were caused by an air bubble; however, no air bubble was seen in the devices or the patient.

• 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: 18967613
• MDR Text Key: 338471226
• Report Number: 9612164-2024-01421
• Device Sequence Number: 1
• Product Code: DRA
• UDI-Device Identifier: 00763000659080
• UDI-Public: 00763000659080
• 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,Followup
• Report Date: 05/22/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 10FCC13
• Device Catalogue Number: 10FCC13
• Device Lot Number: 0012106995
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/11/2024
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 02/29/2024
• Initial Date FDA Received: 03/25/2024
• Supplement Dates Manufacturer Received: 03/27/2024; 04/26/2024
• Supplement Dates FDA Received: 03/28/2024; 05/22/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/11/2024
• 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 Outcome(s): Other
• Patient Sex: Female