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); Tachycardia (2095); Ventricular Fibrillation (2130)

Event Date 10/27/2021

Event Type  Death  

Manufacturer Narrative

Concomitant medical products: 990063-020 mapping catheter.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 patient's blood pressure was not as expected requiring vasopressors to be administered.The patient went into ventricular tachycardia (vt) multiple times.It was observed on the intra-cardiac echocardiogram when the epinephrine took effect, the heart started beating rapidly prior to going into vt.Cardioversion was attempted four times.After the fourth shock was given, the patient went into ventricular fibrillation (vf).Compressions were initiated.Post code, a cardiac catherization was performed and the coronary arteries were found to be clean.The patient had a heart pump placed and sent to the intensive care unit (icu).The case was aborted under general anesthesia.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 0010818787 was returned and analyzed.The files showed at least four applications were performed with the balloon catheter without any issue on the date of the event.Visual inspection before functional testing and dissection was performed on the shaft, handle, and dilator.No anomaly was identified during the external visual inspection.The handle, shaft and sideport 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 psig showed the pressure decay in the device was 0.004 psig.The flushing test with 6 psig showed the pressure decay in the device was 0.005 psig.The aspiration test with negative pressure of 4.1 psig showed the pressure decay in the device was 0.016 psig.All 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 clinical issues (arrhythmia, hypotension) occurred during the procedure and death occurred a day after the procedure.The case was aborted under general anesthesia.There is no indication of relation of 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.

Event Description

It was later reported the patient passed away one day post-procedure.

• 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: paula bixby ; 8200 coral sea st ne; mounds view, MN 55112 ; 7635055378
• MDR Report Key: 12836423
• MDR Text Key: 280958843
• Report Number: 3002648230-2021-00531
• 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: 12/16/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/18/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 09/09/2023
• Device Model Number: 4FC12
• Device Catalogue Number: 4FC12
• Device Lot Number: 0010818787
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/24/2021
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/03/2021
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 09/09/2021
• 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
• Patient Outcome(s): Death; Required Intervention; Life Threatening; Hospitalization
• Patient Age: 79 YR
• Patient Sex: Male
• Patient Weight: 102 KG