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

Model Number 4FC12

Device Problems Material Deformation (2976); Material Twisted/Bent (2981); Adverse Event Without Identified Device or Use Problem (2993); Device Handling Problem (3265)

Patient Problem Pericardial Effusion (3271)

Event Date 09/22/2023

Event Type  Injury  

Manufacturer Narrative

Medtronic is submitting this report to comply with fda reporting regulations under 21 cfr parts 4 and 803.This report is based upon information obtained by medtronic, which the company may not have been able to fully investigate or verify prior to the date the report was required by the fda.Medtronic has made reasonable efforts to obtain more complete information and has provided 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.In particular, this report does not constitute an admission by anyone that the product described in this report has any ¿defects¿ or has ¿malfunctioned¿.These words are included in the fda 3500a form and are fixed items for selection created by the fda to categorize the type of event solely for the purpose of regulatory reporting.Medtronic objects to the use of these words and others like them because of the lack of definition and the connotations implied by these terms.This statement should be included with any information or report disclosed to the public under the freedom of information act.Any required fields that are unpopulated are blank because the information is currently unknown or unavailable.A good faith effort will be made to obtain the applicable information relevant to the report.If information is provided in the future, a supplemental report will be issued.

Event Description

It was reported that during a cryo ablation procedure, the sheath was not preforming as expected. the case was completed with cryo.Upon removing the sheath from the patient, it was observed that the sheath was "mangled".The patient developed a pericardial effusion and pericardiocentesis was performed.It is unknown if the patient was hospitalized or had an extended hospitalization. no further patient complications have been reported as a result of this event.

Manufacturer Narrative

Product event summary: the data files and 4fc12 sheath with lot number 0011835145 were returned and analyzed.The patient data files showed at least four applications were performed with the (b)(4) balloon catheter with lot number 10805 on the reported event date without any system notice or anomaly.The failure data file and powerup test data file were not available for analysis.In the two pictures, the shaft of the sheath was kinked at the tip.The lot and serial number of the sheath were not displayed on the pictures.Visual inspection of the shaft area was performed and inspection identified a shaft kink/twist at approximately 1.527 inches from the tip.The steering mechanism and deflection test were performed.The shaft was bending as initially intended and was bending in the plane.There was no difficulty, no friction, or any noise in the steering mechanism.The pressure test with 30 pounds per square inch gauge (psig) showed the pressure decay in the device was 0.035 psig.The flushing test with six psig showed the pressure decay in the device was -0.004 psig.The aspiration test with negative pressure of 4.1 psig showed the pressure decay in the device was 0.001 psig.The performance tests were in the acceptable range.The shaft, side tube, and valve were all leak-tight with no apparent issue.In conclusion, the reported adverse event (pericardial effusion) occurred during the procedure, the shaft damage/kink was confirmed during analysis and the steerability issue was not confirmed/reproduced.The sheath failed the return product inspection due to a kink/twist on the shaft.Medtronic is submitting this report to comply with fda reporting regulations under 21 cfr parts 4 and 803.This report is based upon information obtained by medtronic, which the company may not have been able to fully investigate or verify prior to the date the report was required by the fda.Medtronic has made reasonable efforts to obtain more complete information and has provided 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.In particular, this report does not constitute an admission by anyone that the product described in this report has any ¿defects¿ or has ¿malfunctioned¿.These words are included in the fda 3500a form and are fixed items for selection created by the fda to categorize the type of event solely for the purpose of regulatory reporting.Medtronic objects to the use of these words and others like them because of the lack of definition and the connotations implied by these terms.This statement should be included with any information or report disclosed to the public under the freedom of information act.Any required fields that are unpopulated are blank because the information is currently unknown or unavailable.A good faith effort will be made to obtain the applicable information relevant to the report.If information is provided in the future, a supplemental report will be issued.

• Brand Name: FLEXCATH ADVANCE STEERABLE SHEATH
• Type of Device: 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: 17948551
• MDR Text Key: 325804564
• Report Number: 3002648230-2023-00484
• Device Sequence Number: 1
• Product Code: DRA
• UDI-Device Identifier: 00763000418052
• UDI-Public: 00763000418052
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K123591
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 11/07/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/17/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 4FC12
• Device Catalogue Number: 4FC12
• Device Lot Number: 0011835145
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/17/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/30/2023
• 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): Required Intervention
• Patient Sex: Female