MAUDE Adverse Event Report: COOK INC UNKNOWN

Catalog Number UNKNOWN

Device Problem Flaked (1246)

Patient Problems Foreign Body Reaction (1868); No Code Available (3191)

Event Type  Injury  

Manufacturer Narrative

(b)(4).This report includes information known at this time.A follow-up report will be submitted should additional relevant information become available.Fealey et.Al, (2008), complication of endovascular polymers associated with vascular introducer sheaths and metallic coils in 3 patients, with literature review, vol.32 pp1310-1316, american journal of surgery and pathology.[(b)(4)].

Event Description

A journal article titled: " complications of endovascular polymers associated with vascular introducer sheaths and metallic coils in 3 patients, with literature review" was reviewed.According to the authors, "hydrophilic coatings on arterial introducer sheaths reduce the frequency of spasm during cardiac catheterization.Moreover, during treatment of cerebral artery aneurysms, hydrophilic coatings on microcatheters ease their maneuverability, and polymers within embolization coils enhance neointimal fibrosis at the aneurysm neck.Foreign-body giant cell reactions can result when a polymer is stripped from its source".The article included case studies and 2 of the case studies included patients that underwent procedures where cook devices were used.The author reported, a (b)(6)-year-old man, with a history of carotid endarterectomy, underwent coronary angiography in 2003 using a right radial artery access site.The cook ((b)(4)) introducer sheath had a hydrophilic coating.Soon after the procedure, he developed a swollen, tender, red lesion on his right wrist.This was thought to represent an infectious process or pseudoaneurysm and was resected fourteen days after the cardiac catheterization procedure.A portion of the tissue was submitted for bacterial, fungal, and mycobacterial cultures, all of which were negative.Microscopy showed a periadventitial foreign-body giant cell response, without medial involvement.On higher magnification, numerous eosinophils were also identified.The filamentous foreign material had a finely granular appearance and was blue-gray with hematoxylin-eosin staining.The material did not show bi-refringence under polarized light.In addition, special stains were negative for fungi and acid-fast bacilli.No additional adverse effects were reported.Refer to medwatch with manufacturer report number as follows for the other case: 1820334-2018-01280.

Event Description

No additional information regarding the patient and/or event has been received since the previous medwatch report was sent.Refer to section h10 for investigational findings.

Manufacturer Narrative

Blank fields on this form indicate the information is unknown, unavailable, or unchanged.Clinical assessment: there are no medical records for review.There is no information that sheds light on the patient¿s immune system.The pathology results leave little doubt the foreign material was hydrophilic coating that had been dislodged during the procedure.There were additional devices used during this event.The manufacturer and brand names of these devices are not known and it is not known if these devices met their manufacturing quality specifications and caused excessive friction causing the hydrophilic coating to scrape off.The device product and lot number are not available.There are no dates for this procedure available, but the article was first published 2008.At this time, the most probable cause of this event is manufacturing related.However disease progression, other device compatibility and medical procedure related factors cannot be entirely ruled out.Investigation-device evaluation: the complaint device was not returned for investigation; therefore, no physical examinations could be performed.Additionally, the product number of the cook sheath is unknown.However, given that the complaint device included a hydrophilic coating (hc), we can conclude that the product is from the flexor guiding sheath family as these are the only sheath products from cook that include the hc coating.With no specific product number to reference, a document based investigation was performed which focused on the hc coating.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 and complaint history could not be conducted.Numerous design verification and validation activities have been performed to ensure that this device meets design requirements.Based on the information provided, no product returned and the results of our investigation, a definitive root cause could not be determined.We will continue to monitor for similar complaints.Per the quality engineering risk assessment, no further action is required.This report is required by the fda under 21 cfr part 803 and is based on unconfirmed information submitted by others.Neither the submission of this report nor any statement contained herein is intended to be an admission that any cook device is defective or malfunctioned, that a death or serious injury occurred, nor that any cook device caused, contributed to, or is likely to cause or contribute to a death or serious injury if a malfunction occurred.- attachment: [fealey_complications_of_endovascular_polymers_lit_review.Pdf].

• Brand Name: UNKNOWN
• Manufacturer (Section D): COOK INC; 750 daniels way; bloomington IN 47404
• MDR Report Key: 7495914
• MDR Text Key: 107692489
• Report Number: 1820334-2018-01279
• Device Sequence Number: 1
• Product Code: DQO
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,literatur
• Type of Report: Initial,Followup
• Report Date: 07/27/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 04/12/2018
• Initial Date FDA Received: 05/08/2018
• Supplement Dates Manufacturer Received: 07/20/2018
• Supplement Dates FDA Received: 07/27/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 51 YR