MAUDE Adverse Event Report: COOK INC UNKNOWN

Catalog Number UNKNOWN

Device Problem Flaked (1246)

Patient Problems Infarction, Cerebral (1771); Death (1802); Embolus (1830)

Event Date 03/19/2010

Event Type  Death  

Manufacturer Narrative

Common name and product code = unavailable as the device lot number, rpn, and gpn are unknown.Concomitant medical products: echelon 10 microcatheter, matrix2 coil, guglielmi coils, 6f80cm shuttle sheath, 0.035 cook bentson guidewire, simmons 2 catheter, 5f vtk catheter, fasdasher 14 microguidewire and 0.038 terumo glidewire.(b)(4).Pma/510(k) number = unavailable as the device lot number, rpn, and gpn are unknown.Pma/510(k) number = pre-amendment.This report includes information known at this time.A follow-up report will be submitted should additional relevant information become available.Mehta et al., (2010), hydrophilic polymer emboli: an under-recognized iatrogenic cause of ischemia and infarct.Vol 23, pp 921-930 modern pathology, retrieved from: www.Modernpathology.Org.

Event Description

A journal article was reviewed, "hydrophilic polymer emboli: an under-recognized iatrogenic cause of ischemia and infarct" which discussed the concern that there is potential for embolization of materials introduced into the vasculature due to the increased use of percutaneous intravascular diagnostic and therapeutic devices; specifically hydrophilic polymer coating of these devices.The article included case studies and 6 of the case studies included patients that underwent procedures where cook devices were used.The author reported an (b)(6) woman with an unresectable supraclinoid carotid artery aneurysm presented with subarachnoid hemorrhage and underwent coil embolization of the aneurysm using a combination of polymer-coated medical devices.The patient never fully regained consciousness after the procedure.Magnetic resonance imaging (mri) and magnetic resonance angiography (mra) on postoperative day 2 revealed scattered areas of acute infarct involving multiple bilateral vascular territories within the cerebral hemispheres, cerebellum, and pons.It was stated that there were foreign body emboli in the b/l cerebral cortex, cerebellum, brainstem and leptomeninges.The brain at autopsy showed innumerable (diffuse) intravascular aggregates of amorphous foreign material, which was non-refractile, non-polarizable, granular, and predominantly basophilic.Rare vessels within the pons and cerebellum also contained lamellated eosinophilic foreign material.Vascular stenosis and obliteration were associated with discrete zonal areas of infarct and neointimal proliferation within the subcortical white matter, brainstem, and cerebellum.Scattered foci of foreign body reaction with giant cells were seen.Approximately 100 arteries (ranging from 13 to 400 mm in diameter) were affected in 40 tissue sections of the brain sampled at autopsy.During preliminary investigation activities, it was noted the 5f vtk catheter is a cook product; therefore, this report is being submitted.Refer to related medwatch: 1820334-2018-01124.

Manufacturer Narrative

Investigation ¿ evaluation.A review of the documentation and quality control of the device was conducted during the investigation.The complaint device was not returned; therefore, no physical examinations could be performed; however, a document based investigation evaluation was performed.There is no evidence to suggest the product was not made to specifications.The lot number of the device is not known; accordingly, a review of the device history record could not be conducted.Based on the information provided, no product returned and the results of our investigation, a definitive root cause could not be determined.Measures are being conducted to address this failure mode.We will continue to monitor for similar complaints.Per the risk assessment, no further action is required.

Event Description

No additional information regarding the patient and/or event has been received since the previous medwatch report was sent.

• Brand Name: UNKNOWN
• Manufacturer (Section D): COOK INC; 750 daniels way; bloomington IN 47404
• Manufacturer (Section G): COOK INC; 750 daniels way; bloomington IN 47404
• Manufacturer Contact: larry pool ; 750 daniels way; bloomington, IN 47404 ; 8123392235
• MDR Report Key: 7522572
• MDR Text Key: 108553292
• Report Number: 1820334-2018-01507
• Device Sequence Number: 1
• Product Code: HCG
• Combination Product (y/n): N
• Reporter Country Code: US
• 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,Followup
• Report Date: 06/27/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/17/2018
• Device Operator: Health Professional
• Device Catalogue Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 06/13/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: 0.038 TERUMO GLIDEWIRE, (CONTINUED IN H10)
• Patient Outcome(s): Death
• Patient Age: 87 YR