MAUDE Adverse Event Report: COVIDIEN (IRVINE) MARKSMAN CATHETER; CATHETER, CONTINUOUS FLUSH

Device Problem Appropriate Term/Code Not Available (3191)

Patient Problem Foreign Body Reaction (1868)

Event Date 03/08/2018

Event Type  Injury  

Manufacturer Narrative

Sablani, n., hasan, m.M., shrestha, a., <(>&<)> farkas, j.(2018).Delayed neurological deficits after endovascular placement of a pipeline embolisation device: clinical manifestation and treatment.Bmj case reports.Doi:10.1136/bcr-2016-216580 the marksman catheter has not been returned for evaluation.The device was not returned; the reported event could not be confirmed.The cause of the event could not be conclusively determined from the reported information.If information is provided in the future, a supplemental report will be issued.

Event Description

Medtronic literature review found a report of inflammatory reaction to marksman hydrophilic coating after a procedure.A middle-aged women presented with chronic headache associated with mild visual changes.Ct scan identified a 7mm, wide neck supraclinoid internal carotid artery (ica) aneurysm.The patient elected to undergo flow diversion treatment.During the procedure, the article states that a marksman microcatheter was unable to be navigated past the aneurysm neck.A guidewire was attempted, then a hydrophilic wire was attempted to guide the marksman without success.A combination of both wires was then used to advance the marksman through the supraclinoid ica into the distal middle cerebral artery.A flow diverter was placed.The procedure was completed without any further issues.Follow-up ct of the head showed no hemorrhage or ischemic changes.The patient was discharged on dual antiplatelet therapy.At the two-week follow-up appointment, the patient reported experiencing severe right-sided headaches that had been going on for three days.The patient described the headache as persistent, sharp, and 10/10 in severity.The headaches were associated with nausea, photophobia, phonophobia, left hand and leg weakness with numbness, and a tingling sensation of the left lower extremities.Neurological exam during the office visit was unremarkable.The patient underwent urgent, non-contrast ct of the head, which did not reveal anything significant.The patient was given zofran, reglan and fioricet in the emergency department with resolution of symptoms and was discharged with a diagnosis of migraine, along with orders for an outpatient mri.The patient's outpatient brain mri without contrast showed multiple areas of abnormal signal within the subcortical white matter at the right frontal, parietal, occipital and temporal lobes, with vasogenic edema and negative diffusion restriction.Based on the mri findings, the patient was asked to return to the hospital the same day for admission and further work-up.The patient reported that the symptoms were progressing.Neurological exam was significant for left upper and lower extremity weakness, with 4 out of 5 on strength testing, as compared with 5 out of 5 strength in her right upper and lower extremities.She also exhibited decreased sensory perception on her left side in comparison with her right.Cranial nerves were intact and there were no meningeal signs.An mri with contrast was performed in the hospital; the t1 postcontrast sequences showed multiple, rounded, enhancing foci at the right frontal, parietal, temporal and occipital regions.The patient was administered a high dose of methylprednisolone 250 mg intravenously every 6 hours for 1 day, with marked symptomatic improvement in her headaches and left-sided weakness and paresthesia, and then was switched to prednisone 30 mg daily, which was slowly tapered over a course of 2 months.Two follow-up mris with and without contrast showed near-complete resolution of the enhancing lesions.The authors believed that the patient had gradually developed a delayed inflammatory reaction, likely to poly-vinylpyrrolidone (pvp), which responded well to a course of steroids.

• Brand Name: MARKSMAN CATHETER
• Type of Device: CATHETER, CONTINUOUS FLUSH
• Manufacturer (Section D): COVIDIEN (IRVINE); 9775 toledo way; irvine CA 92618
• Manufacturer (Section G): COVIDIEN (IRVINE); 9775 toledo way; irvine CA 92618
• Manufacturer Contact: tricha miles ; 9775 toledo way; irvine, CA 92618 ; 9496801224
• MDR Report Key: 7449114
• MDR Text Key: 106134886
• Report Number: 2029214-2018-00313
• Device Sequence Number: 1
• Product Code: KRA
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K091559
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,literatur
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 04/20/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/20/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/27/2018
• 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): Other