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 Problem Hematoma (1884)

Event Date 04/19/2016

Event Type  Injury  

Manufacturer Narrative

Silverberg d, menes t, rimon u, salomon o, halak m.Acute renal artery occlusion: presentation, treatment, and outcome.Journal of vascular surgery.2016;64(4):1026-1032.Doi:10.1016/j.Jvs.2016.04.043 see manufacturer report # 2029214-2022-00596 for another report from this article.If information is provided in the future, a supplemental report will be issued.

Event Description

Silverberg d, menes t, rimon u, salomon o, halak m.Acute renal artery occlusion: presentation, treatment, and outcome.Journal of vascular surgery.2016;64(4):1026-1032.Doi:10.1016/j.Jvs.2016.04.043 medtronic literature review found a report of patient complications in association with a cragg-mcnamara infusion catheter.The purpose of this article was to identify patients with acute kidney infarction; to characterize their presentation, imaging, and treatment; and to compare the subgroup of patients who underwent catheter-directed thrombolysis (cdt) with those who were treated without intervention.Thirteen patients were treated with cdt, which involved the use of the cragg-mcnamara catheter.Of the 13 patients, 11 were male and the average age was 59 years.All cdt patients completed the treatment, and no major complications occurred during the course of the thrombolytic therapy.The article does not state any technical issues during use of the cragg-mcnamara catheter.The following intra- or post-procedural outcomes were noted: three patients required dialysis despite cdt.One underwent temporary hemodialysis for 3 weeks until renal function improved.The other two, both kidney transplant patients, required permanent hemodialysis despite the treatment.Partial thrombus resolution was seen in 3 patients.Partial success was defined as removal of the majority of the thrombus with residual clot seen on completion angiography.Four patients required additional placement of a stent after the thrombolytic treatment.Two patients developed small groin hematomas that were treated nonoperatively.

• 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: 14046143
• MDR Text Key: 293343950
• Report Number: 2029214-2022-00597
• Device Sequence Number: 1
• Product Code: KRA
• Combination Product (y/n): N
• Reporter Country Code: IS
• 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
• Report Date: 04/07/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/07/2022
• 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: 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: 59 YR
• Patient Sex: Male