MAUDE Adverse Event Report: MICRO THERAPEUTICS, INC. DBA EV3 CRAGG-MCNAMARA; CATHETER, CONTINUOUS FLUSH

Model Number UNK-NV-CRAGG-MC

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

Patient Problems Hematoma (1884); Hemorrhage/Bleeding (1888); Pain (1994); Vomiting (2144)

Event Date 01/01/2021

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

Taghavyan nj, mashayekh a, pouraliakbar hr, et al.Spontaneous intramural esophageal hematoma secondary to thrombolysis in the setting of pulmonary embolism.Vascular and endovascular surgery.2021;55(5):510-514.Doi:10.1177/1538574421989863.Medtronic literature review found a report of patient complications in association with a cragg-mcnamara infusion catheter.The purpose of this article was to present 2 cases of intramural hematoma of the esophagus (ihe) associated with catheter-directed thrombolysis (cdt) in the setting of pulmonary embolism.The article does not state any technical issues during use of the cragg-mcnamara infusion catheter.The following intra- or post-procedural outcomes were noted:  - a 79-year-old man underwent cdt with 2 cragg-mcnamara infusion catheters placed in both left and right pulmonary arteries, and 24 mg of tissue plasminogen activator (tpa) was infused during a 24-hour period.He developed hematemesis 22 hours after the infusion.Importantly, he had complained of a retrosternal chest pains at least 3 hours of emesis, which no specific management was undertaken by the treating physician.Immediately after clear signs of upper gastrointestinal bleeding (ugib), the thrombolytic agent and the parenteral anticoagulant were stopped, a nasogastric tube for gi washing was inserted, and intravenous proton pump inhibitors were started.Blood transfusion and intravenous fluid therapy were also started according to gi consult.Ugi endoscopy was straightaway scheduled for the patient, and it showed massive submucosal hematoma with oozing.Ihe was confirmed by thoracic spiral ct scanning.Due to the temporary cessation of anticoagulation therapy and the critical condition of our patient, an inferior vena cava (ivc) filter was placed.They followed him with chest ct scanning and found hematoma healing and absorption after a period of 7 days.Fortunately, the patient was stable in terms of pe during the whole period.After 14 days, oral anticoagulation (apixaban) was started and the ivc filters were removed.He was discharged after complete recovery. - a 62-year-old man underwent cdt with 2 infusion catheters were placed in both left and right pulmonary arteries, and 24 mg of tpa was infused during a 24-hour period.18 hours after, hematemesis was occurred.Unfortunately, like the previous case, the second patient had also complained about retrosternal chest pains about 3-4 hours before the ugib, which was not consider as an important symptom by the treating physician.As previously described for the first patient, fibrinolytic agent was stopped, and gib workup were proceeded.A massive submucosal hematoma with oozing were detected by ugi endoscopy which was confirmed by thoracic spiral ct scan.Anticoagulation therapy has been temporally stopped and due to the risk of re-pe, an inferior vena cava ivc filter were inserted.Ihe was absorbed after 10 days in the follow up chest ct scan.According to the gi consult, after 2 weeks, the oral anticoagulation therapy (apixaban) was restarted and ivc filter was removed.The patient was discharge in a good condition.

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

Additional information was received that the adverse events listed within the article were not related to medtronic devices, but due to thrombolytic.

• Brand Name: CRAGG-MCNAMARA
• Type of Device: CATHETER, CONTINUOUS FLUSH
• Manufacturer (Section D): MICRO THERAPEUTICS, INC. DBA EV3; 9775 toledo way; irvine CA 92618
• Manufacturer (Section G): MICRO THERAPEUTICS, INC. DBA EV3; 9775 toledo way; irvine CA 92618
• Manufacturer Contact: glen belmer ; 9775 toledo way; irvine, CA 92618 ; 6122713209
• MDR Report Key: 17446900
• MDR Text Key: 320288062
• Report Number: 2029214-2023-01272
• Device Sequence Number: 1
• Product Code: KRA
• Combination Product (y/n): N
• Reporter Country Code: IR
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Literature,Health Professional
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 12/22/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/02/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: UNK-NV-CRAGG-MC
• Device Catalogue Number: UNK-NV-CRAGG-MC
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/14/2023
• 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 Age: 70 YR
• Patient Sex: Male
• Patient Weight: 68 KG