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

Model Number 41057-01

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

Patient Problems Hematoma (1884); Hemorrhage/Bleeding (1888); Pseudoaneurysm (2605)

Event Date 01/01/1993

Event Type  Injury  

Manufacturer Narrative

Lee d, waldman d, sumida r, green r.Direct graft puncture with use of a crossed catheter technique for thrombolysis of peripheral bypass grafts.Jvir 2000; 11:445¿ 452.Doi: 10.1016/s1051-0443(07)61376-1.Reported patient age (70 years) is representative of the average age of all patients included in the study.Reported patient sex (male) is representative of the majority of patients included in the study.If information is provided in the future, a supplemental report will be issued.

Event Description

Lee d, waldman d, sumida r, green r.Direct graft puncture with use of a crossed catheter technique for thrombolysis of peripheral bypass grafts.Jvir 2000; 11:445¿ 452.Doi: 10.1016/s1051-0443(07)61376-1.The purpose of this article was to determine the efficacy and safety of direct graft puncture of peripheral arterial bypass grafts with placement of retrograde and antegrade catheters within the graft for thrombolytic therapy.This study also evaluated potential clinical benefit to patients.The authors reviewed 19 patients with 24 peripheral bypass grafts and lower extremity ischemia of less than 1 month duration.Thrombolysis was performed with a continuous high-dose infusion of urokinase.Successful lysis was defined as greater than 95% clot dissolution with antegrade flow within the graft.In five cases, a mewissen catheter (boston scientific vascular, (b)(4)) was used for infusion.The remainder utilized craggmcnamara infusion catheters (mti, (b)(4)), which were placed across both anastomoses.In 10 of 19 (52%) patients, the catheter was left proximal to the distal anastomosis because of an inability to cross the anastomosis with a guide wire (six of nine), or concern that the catheter would occlude a stenotic anastomosis (four of 19).Arterial sheaths (5¿ 6 f) were placed in 11 of 19 (58%) at the discretion of the interventional radiologist.The remainder of cases (eight of 19) had only the infusion catheters left in place.In our study, there was one death that occurred during hospitalization.This patient died approximately 3 weeks after the procedure of a hospital-acquired pneumonia that occurred 2 weeks after surgery.Of the 19 patients, the average age was 70 years, there were 6 women and 13 men.The following intra- or post-procedural outcomes were noted: 1.Hemorrhage 2/19 (11%) 2.Pseudoaneurysm 1/19 (5%) 3.Hematoma 1/19 (5%) 4.Death due to pneumonia 1/19.

• 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: 14292009
• MDR Text Key: 294656322
• Report Number: 2029214-2022-00773
• Device Sequence Number: 1
• Product Code: KRA
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Literature,Health Professional
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 05/04/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/05/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 41057-01
• Device Catalogue Number: 41057-01
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/06/2022
• 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