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

Model Number 4FC12

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Low Blood Pressure/ Hypotension (1914); Cardiac Tamponade (2226); Pericardial Effusion (3271)

Event Date 11/22/2023

Event Type  Injury  

Manufacturer Narrative

Section a: select patient information cannot be provided due to regional privacy regulations.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 after the transeptal puncture, the sheath was replaced and the other devices were assembled.During preparation of the connecting wire, the patient's blood pressure dropped rapidly and the patient became hypotensive.It was suspected that the patient had pericardial effusion.Imaging was carried out to identify the effusion.The patient developed cardiac tamponade.Unknown intervention took place; however, the patient's hypotension did not recover.The patient's condition later stabilized and the patient was returned to the ward.The case was aborted while the patient was under general anesthesia. it is unknown if the patient's hospitalization was extended.No further patient complications have been reported as a result of this event.

Manufacturer Narrative

Product event summary: the 4fc12 sheath with the lot number 0011695427 was returned analyzed.Visual inspection was performed and no anomaly was identified during the external visual inspection.The handle, shaft and sideport were intact with no apparent issues.The dilator was not returned.Functional testing was performed.The steering mechanism and deflection test revealed a noise was heard from the handle when the knob was turning with friction.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 0.049 psig.The flushing test with 6 psig showed the pressure decay in the device was 0.003 psig.The aspiration test with negative pressure of 4.1 psig showed the pressure decay in the device was 0.006 psig.All the performance tests were in the acceptable range.The shaft, side tube, and valve were all leak-tight with no apparent issue.The relevant sub-assembly inspection and tests were performed.Dissection of the returned sheath revealed a kinked pull wire in the barrel of the handle area and debris at the floater disk.In conclusion, the clinical issues (tamponade, effusion and hypotension) occurred during the procedure with no indication that the adverse event was related to the performance or a malfunction of the product.The decision to abort the procedure without use of alternate therapy was based upon the medical judgment of the physician.The sheath failed the return inspection due to a kinked pull wire in the barrel of the handle area and debris at the floater disk.Product analysis # (b)(4) :analysis information -- 2024-01-04 13:43:47 cst pli# 30 product id# 4fc12 the flexcath advance sheath was visually inspected, functionally tested as per product analysis guidelines (b)(4).A kinked/bent pull wire was observed at the barrel.Foreign debris was observed at the pull wire/floater disk inside handle.Analysis date: 2024-01-04 result of analysis: the returned device identification matches the reported complaint product identification.The product was received in a biohazard kit.Prior to product analysis, the product was decontaminated as per procedure (b)(4).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 sideport were intact with no apparent issue.The dilator wasn't returned.The following functional testing was performed.Observations are listed below: the steering mechanism and deflection test revealed the noise is heard from the handle when the knob is turning with friction.The performance test with sentinel blackbelt leak tester was performed.1- the pressure test with 30 psig showed the pressure decay in the device was 0.049 psig (should be less than 0.3 psig).2- the flushing test with 6 psig showed the pressure decay in the device was 0.003 psig (should be less than 0.2 psig).3- the aspiration test with negative pressure of 4.1 psig showed the pressure decay in the device was 0.006 psig (should be less than 0.2 psig).All the performance tests were in the acceptable range.The shaft, side tube, and valve were all leak-tight with no apparent issue.The following relevant sub-assembly inspection and tests were performed.Observations are listed below: dissection of the returned device revealed a kinked pull wire in the barrel of handle area.Supporting evidence is shown in the pli attachment.Dissection of the returned device revealed debris is at the floater disk.Supporting evidence is shown in the pli attachment.The device will be retained for a period of 1 year and available for further review.This analysis finding code is being monitored as part of the cardiac ablation solutions data monitoring plan.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: 18265867
• MDR Text Key: 329720705
• Report Number: 3002648230-2023-00559
• Device Sequence Number: 1
• Product Code: DRA
• Combination Product (y/n): N
• Reporter Country Code: CH
• PMA/PMN Number: K123591
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 02/01/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/05/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 4FC12
• Device Catalogue Number: 4FC12
• Device Lot Number: 0011695427
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/04/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/26/2023
• 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: AFAPRO28 BALLOON CATHETER, 2ACH20 MAPPING CATHETER
• Patient Outcome(s): Required Intervention; Life Threatening