MAUDE Adverse Event Report: COOK INC CLOVERSNARE¿ 4-LOOP VASCULAR RETRIEVER; MMX DEVICE, PERCUTANEOUS RETRIEVAL

Catalog Number	VRS-6.0-90
Medical Device Problem Code	Material Frayed (1262)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	07/02/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Per the initial reporter, the device will not be returned.(b)(4).This report includes information known at this time.A follow-up report will be submitted should additional relevant information become available.
Event or Problem Description
It was reported, during another manufacturer's inferior vena cava (ivc) filter removal, it was discovered the inner lumen of the outer 10 french (fr) cloversnare¿ 4-loop vascular retriever sheath was frayed.After retrieval of the ivc filter, blue plastic material was noted when the sheath was flushed outside of the patient's vasculature.The filter is intact.The sheath was damaged by the legs of the ivc filter.During follow up of the event, it was reported the access site was the right internal jugular vein.No vessel scarring, calcification, or tortuosity was noted; however, there was tissue indwell growth at the feet of existing ivc filter.A section of the device did not remain inside the patient¿s body.The patient did not require any additional procedures due to this occurrence.According to the initial reporter, the patient did not experience any adverse effects due to this occurrence.
Additional Manufacturer Narrative
Blank fields on this form indicate the information is unknown, unavailable, or unchanged.Investigation - evaluation.A review of the device history record, manufacturing instructions, quality control, complaint history, drawing, and instructions for use (ifu) 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.A review of the device history record shows no nonconforming events which could contribute to this failure mode.It should be noted there were no other reported complaints for this lot number.As part of the design history file testing for this device, a simulated use study was performed, including the removal of wire guide sections, catheter sections, and filters from a venous model.One of the acceptance criteria for the study was that the device shall be proven capable of capturing and releasing objects of varying size, shape, and orientation.The two filters (celect and tulip) were retrieved from the vena cava by three different test articles from both the left and right jugular of the model.The filters were able to be captured, released and re-captured by the device.The acceptance criterion for grasping and releasing objects states that the device must grasp the objects and demonstrate its ability to maintain a hold on the objects during removal from the outer introducer sheath.Based on the experimental results, all acceptance criteria were met during the course of this study.These test results demonstrate that the device meets the essential requirements set forth in annex i of council directive 93/42/eec.There is no evidence to suggest the product was not made to specifications.Additionally, the instructions for use (ifu) notably states "this product is intended for use by physicians trained and experienced in diagnostic and interventional techniques.Standard techniques for placement of vascular access sheaths, angiographic catheters, and wire guides should be employed.Excessive force should not be used to manipulate or retrieve foreign objects." based on the information provided, no product returned and the results of our investigation, a definitive root cause could not be determined; however, it is possible that the cause of this event is procedure related.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.This report is based on unconfirmed information submitted by others.Neither the submission of this report nor any statement made in it is intended to be an admission that any cook device is defective or malfunctioned; that a death or serious injury occurred; or that any cook device caused or contributed to; or is likely to cause or contribute to a death or serious injury if a malfunction occurred.
Event or Problem Description
No additional information regarding the patient and/or event has been received since the previous medwatch report was sent.

• Brand Name: CLOVERSNARE¿ 4-LOOP VASCULAR RETRIEVER
• Common Device Name: MMX DEVICE, PERCUTANEOUS RETRIEVAL
• Manufacturer (Section D): COOK INC; 750 daniels way; bloomington IN 47404
• MDR Report Key: 7690967
• Report Number: 1820334-2018-02079
• Device Sequence Number: 2580649
• Product Code: MMX
• UDI-Device Identifier: 10827002530086
• UDI-Public: (01)10827002530086(17)210321(10)8684118
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Initial Reporter Country: US
• PMA/510(K) Number: K112185
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 10/25/2018

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?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 03/21/2021
• Device Catalogue Number: VRS-6.0-90
• Device Lot Number: 8684118
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 07/02/2018
• Supplement Date Received by Manufacturer: 10/05/2018
• Initial Report FDA Received Date: 07/16/2018
• Supplement Report FDA Received Date: 10/25/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1