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

Catalog Number VRS-6.0-90

Device Problem Material Separation (1562)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 10/28/2019

Event Type  malfunction  

Manufacturer Narrative

Occupation: unknown.A follow-up report will be submitted should additional relevant information become available.

Event Description

As reported, during retrieval of another manufacturer's inferior vena cava (ivc) filter, reportedly placed in 2012, one of the loop connection points on the cloversnare 4-loop vascular retriever detached from the main body of the device.Reportedly, excessive force was used while attempting to pull the filter into the sheath.Nothing separated from the device, and no material became detached inside the patient.The filter was then successfully retrieved using a cook gunther tulip retrieval set.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.

Event Description

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

Manufacturer Narrative

Description of event: as reported, during retrieval of another manufacturer's inferior vena cava (ivc) filter, reportedly placed in 2012, one of the loop connection points on the cloversnare 4-loop vascular retriever detached from the main body of the device.Reportedly, excessive force was used while attempting to pull the filter into the sheath.Nothing separated from the device, and no material became detached inside the patient.The filter was then successfully retrieved using a cook gunther tulip retrieval set.Investigation ¿ evaluation.Reviews of the complaint history, drawing, instructions for use (ifu), and quality control procedures of the device were 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.The lot number of the device is not known; accordingly, a review of the device history record could not be conducted.Furthermore, reviews of the quality control procedures and device drawings were conducted, and no gaps were discovered.Because adequate inspection activities have been established, it was concluded that that the device was manufactured to specifications.An ifu is also provided with this device, which states, "excessive force should not be used to manipulate or retrieve foreign objects." based on the information provided and no product returned, investigation has concluded that a definitive root cause for this event could not be determined, though the most likely causes for the device failure were the patient's anatomy and the excessive force reportedly applied to the device during filter removal.The filter was placed in 2012, and it is likely that the filter struts were significantly ingrown, which would require significant force to remove and in turn could cause the snare loop to fracture.We will continue our monitoring of similar complaints and have notified the appropriate personnel of this event.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.

• Brand Name: CLOVERSNARE¿ 4-LOOP VASCULAR RETRIEVER
• Type of Device: MMX DEVICE, PERCUTANEOUS RETRIEVAL
• Manufacturer (Section D): COOK INC; 750 daniels way; bloomington IN 47404
• MDR Report Key: 9279300
• MDR Text Key: 165084208
• Report Number: 1820334-2019-02780
• Device Sequence Number: 1
• Product Code: MMX
• Combination Product (y/n): N
• PMA/PMN Number: K112185
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,user f
• Type of Report: Initial,Followup
• Report Date: 02/24/2020

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
• Device Operator: Health Professional
• Device Catalogue Number: VRS-6.0-90
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 10/30/2019
• Initial Date FDA Received: 11/05/2019
• Supplement Dates Manufacturer Received: 02/17/2020
• Supplement Dates FDA Received: 02/24/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: ARGON IVC FILTER; ARGON IVC FILTER