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

Model Number	12FCC13
Medical Device Problem Codes	Use of Device Problem (1670); Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Pericardial Effusion (3271)
Date of Event	09/30/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Continuation of d10: product id: afapro28, product type: balloon catheter; product id: 990032-020, product type: mapping 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 or Problem Description
It was reported that during a cryo ablation procedure, transseptal access was difficult to obtain with the sheath.Following the last ablation, an effusion around the ventricle was observed.Pericardiocentesis was subsequently performed.The case was completed with cryo.No further patient complications have been reported as a result of this event.
Additional Manufacturer Narrative
Product event summary: the 12fcc13 sheath with lot number 0012250161 was returned and analyzed.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 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 0.07155 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 0.00637 psig and in an acceptable range (should be between -0.3 and 0.3 psig).In conclusion, the clinical issue of effusion occurred during the procedure.Additionally, 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: 20392115
• Report Number: 9612164-2024-04575
• Device Sequence Number: 7944516
• Product Code: DRA
• UDI-Device Identifier: 00763000234928
• UDI-Public: 00763000234928
• Combination Product (Y/N): N
• Initial Reporter State: VA
• 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: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 11/29/2024

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?: No
• Operator of Device: Health Professional
• Device Expiration Date: 05/01/2026
• Device Model Number: 12FCC13
• Device Catalogue Number: 12FCC13
• Device Lot Number: 0012250161
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/30/2024
• Supplement Date Received by Manufacturer: 11/05/2024
• Initial Report FDA Received Date: 10/07/2024
• Supplement Report FDA Received Date: 11/29/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/01/2024
• 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
• Concomitant Medical Products and Therapy/Usage Dates: SEE H11.
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 67 YR
• Patient Sex: Male
• Patient Weight: 100 KG