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

Model Number 4FC12

Device Problems Use of Device Problem (1670); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Low Blood Pressure/ Hypotension (1914); Pericardial Effusion (3271)

Event Date 12/26/2023

Event Type  Injury  

Event Description

It was reported that during a cryo ablation procedure, during transeptal access was performed using the sheath and another manufacturer's transseptal needle.It was difficult to visualize the transseptal in intracardiac echocardiography (ice) to see if the needle was in position.The transeptal needle was replaced with a different manufacture's needle but it was still difficult to visualize on ice but eventually the tenting of the needle on the septum was able to be visualized.The septum was accessed and the dilator of the sheath was visualized on both ice and fluoroscopy.The sheath was having difficulty crossing the septum.After the dilator was confirmed to be in the left atrium, the needle was removed and a guidewire was inserted.The sheath was then attempted to cross the septum but without success.The guidewire was removed and the septum was pre-dilated with another manufacturer's sheath and the sheath was again attempted to cross the septum but without success.After multiple attempts using the guidewires to assist with the sheath crossing the septum, the sheath was removed and just the dilator over the guidewire was attempted and it crossed easily.The sheath and dilator combination was again attempted but during this attempt, the patient's blood pressure decreased dramatically.A large effusion was seen on ice.A pericardial drain was placed and anticoagulant reversal medication was given.Approximately one liter of blood was removed.A pressor medication was also given to help stabilize the patient.The patient's effusion resolved and the hemodynamics stabilized.The drain was removed, the case was aborted, and the patient was hospitalized overnight for observation.The patient was discharged the next day. no further patient complications have been reported as a result of this event.

Manufacturer Narrative

Continuation from d10: other manufactuerer's transeptal needle, other manufacturer's sheath, other manufactuerer's guidewire 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.

Manufacturer Narrative

Product event summary: the data files were returned and analyzed.The patient received was empty.The received failure file did not contain any failure records for the date of the event.In conclusion, the reported patient¿s drop in blood pressure and pericardial effusion occurred during the procedure and the decision to abort the procedure without use of alternate therapy was based upon the medical judgment of the physician.The adverse event could not be confirmed through data analysis.There is no indication of a relation of the adverse event to the performance and malfunction of the product.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: 18445886
• MDR Text Key: 331920915
• Report Number: 3002648230-2024-00008
• 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: Physician
• Type of Report: Initial,Followup
• Report Date: 02/08/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/04/2024
• 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: 0012030850
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/22/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/16/2023
• 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
• Treatment: SEE H10
• Patient Outcome(s): Required Intervention; Life Threatening; Hospitalization
• Patient Age: 51 YR
• Patient Sex: Male