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 Hemoptysis (1887); Hemorrhage/Bleeding (1888); Hypoxia (1918); Laceration(s) (1946); Rupture (2208); Thrombosis/Thrombus (4440)

Event Date 01/19/2024

Event Type  Injury  

Manufacturer Narrative

Continuation of d10: product id: afapro28, product type: balloon catheter.Product id: 2ach20, product type: mapping catheter.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.

Event Description

It was reported that during a cryo ablation procedure, pulmonary vein isolation (pvi) was performed in the order of right superior pulmonary vein (rspv) to the right inferior pulmonary vein (ripv) to the right middle pulmonary vein (rmpv) to the left superior pulmonary vein (lspv) to the left inferior pulmonary vein (lipv) and back to the ripv.The patient's blood oxygen saturation dropped near the lspv approach, but recovered with respiratory management.From the end of the last ripv ablation, the patient's blood oxygen saturation decreased even lower and blood sputum was confirmed upon suction.During intubation, hemoptysis was observed; however, hemostasis was achieved shortly after.A bronchogram revealed tears and blood clots in the right lower lobe bronchus, resulting in "conservative treatment." hemorrhaging was observed near the right lower lobe bronchus due to rmpv rupture. it was surmised that the tear might have been caused by advancing the mapping catheter into the thin and shallow rmpv. the case was completed with cryo, but cavotricuspid isthmus (cti) line ablation was not performed. no further patient complications have been reported as a result of this event.

Event Description

It was later reported that conservative treatment was not performed, the patient was subjected to extended hospitalization, and there was a delay in resuming the routine administration of the anticoagulant therapy due to the adverse events.

Manufacturer Narrative

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
• 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: 18622601
• MDR Text Key: 334321558
• Report Number: 3002648230-2024-00031
• Device Sequence Number: 1
• Product Code: DRA
• Combination Product (y/n): N
• Reporter Country Code: JA
• 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: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 04/01/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/01/2024
• 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: 0011894636
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/04/2024
• Date Device Manufactured: 08/15/2023
• 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