MAUDE Adverse Event Report: MEDTRONIC CRYOCATH LP FLEXCATH ADVANCE STEERABLE SHEATH; CATHETER, STEERABLE

Model Number	4FC12
Medical Device Problem Code	Gas/Air Leak (2946)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/11/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Continuation of d10: product id 2af284 (16150); product type: 0624-arctic front 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, air bubbles were observed upon advancement of the balloon catheter into the sheath sideport.The balloon catheter was removed and re-prepped, and the sheath was aspirated and flushed without resolution.The entire system was re-prepped again which resolved the issue.The case was completed with cryo.No patient complications have been reported as a result of this event.
Additional Manufacturer Narrative
Product event summary: the 4fc12 sheath with lot number 0012191910 was returned and analyzed.Visual inspection before functional testing and dissection was performed on the shaft, handle.No anomaly was identified during the external visual inspection.All the handle, shaft and side port were intact with no apparent issue.The functional testing was performed.No anomaly was discovered.The performance test with sentinel blackbelt leak tester was performed.The pressure test with 30 pounds per square inch gauge (psig) showed the pressure decay in the device was 0.03364 psig, the flushing test with six psig showed the pressure decay in the device was 0.00292 psig, and the aspiration test with negative pressure of 4.1 psig showed the pressure decay in the device was 0.00498 psig.All the performance tests were in the acceptable range.The shaft, side tube, and valve were all leak-tight with no apparent issues.In conclusion, the reported issue of "air ingress" was not reproduced during testing, and the sheath passed the returned product inspection as per specification.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 ADVANCE STEERABLE SHEATH
• Common Device Name: CATHETER, STEERABLE
• Manufacturer (Section D): MEDTRONIC CRYOCATH LP; 9000 autoroute transcanadienne; pointe-claire,qc H9R 5 Z8; CA H9R 5Z8
• Manufacturer (Section G): MEDTRONIC CRYOCATH LP; 9000 autoroute transcanadienne; pointe-claire,qc H9R 5 Z8; CA H9R 5Z8
• Manufacturer Contact: alison sweeney ; parkmore business park west; galway ; EI ; 091708096
• MDR Report Key: 19809844
• Report Number: 3002648230-2024-00334
• Device Sequence Number: 8348478
• Product Code: DRA
• UDI-Device Identifier: 00763000418052
• UDI-Public: 00763000418052
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: K123591
• 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): 08/13/2024

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: 03/27/2026
• Device Model Number: 4FC12
• Device Catalogue Number: 4FC12
• Device Lot Number: 0012191910
• 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: 07/11/2024
• Supplement Date Received by Manufacturer: 07/25/2024
• Initial Report FDA Received Date: 07/23/2024
• Supplement Report FDA Received Date: 08/13/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/27/2024
• 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...
• Patient Age: 64 YR
• Patient Sex: Male
• Patient Weight: 104 KG