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 01/09/2019

Event Type  malfunction  

Manufacturer Narrative

Lot number = unknown.Retrieval of filter leg captured under report reference number 3002808486-2019-00119.This report includes information known at this time.A follow-up report will be submitted at the conclusion of the investigation or, when additional relevant information becomes available.

Event Description

As reported, during retrieval of a cook celect filter, a cloversnare 4-loop vascular retriever malfunctioned.The snare reportedly connected ¿nicely¿ to the hook of the filter, but was not able to be retracted.During attempted removal with the complaint device, a leg of the filter fractured (reported under reference number 3002808486-2019-00119).The filter and fractured leg were retrieved with a second snare.When the cook celect filter was returned to the corresponding manufacturer, the complaint device was received with it.Upon receipt of the complaint device, separation was observed near the distal end, as well as accordion damage near the proximal end.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.

Manufacturer Narrative

Investigation evaluation: a review of the instructions for use (ifu), manufacturing instructions, specifications, quality control, and visual inspection of the returned device was conducted during the investigation.The visual inspection of the returned device confirmed accordion damage noted from the connecting cap to approximately 3.7cm.Additionally, a separation was noted approximately 78.1cm from the connecting cap.An attempt was made to operate the snare, and the petals were retracted successfully, however when the wire was advanced, the separated portion of the catheter moved forward and the petals remained in the catheter.A split in the tip was also noted.With this information the complaint can be confirmed, however there is no evidence to suggest that the device was not manufactured to specification.Based on the condition of the returned device and the information reported, it appears as if excessive force may have been used during the attempted filter retrieval.A lot number was not provided; therefore, review of the device history record of the finished product was unable to be performed.Similarly, a complaint history review could not be performed.Furthermore, an instructions for use (ifu) is provided with the device, which cautions the user that excessive force should not be used to manipulate or retrieve foreign objects.The ifu instructs the user to ¿loosen the screw of the clear y-fitting to enable advancement of the snare loops.Holding the clear y-fitting steady, advance the white pin vise.The pin vise can be used to advance, retract, and manipulate loops to capture/surround foreign object.Once the foreign object is captured/surrounded by the loops of the snare, hold the pin vise steady and tighten the screw of the clear y-fitting.If at any time during the procedure, the distance between the pin vise and the y-fitting changes, the screw at the top of the clear y-fitting should be further tightened.¿ if the complaint device is unable to retract once the filter hook is captured, it could result in failure to remove the filter or fracture of the filter within the vena cava.This could lead to abortion of the procedure, additional procedures to remove the filter or retrieve filter fragments, and/or migration of filter fragments, leading to critical injury.Based on the information provided and no product returned, investigation has concluded cause of this event cannot be traced to the device; however appropriate measures have been initiated to address this failure mode.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 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.

Event Description

Additional information was received 29apr2019.The ivc filter was in place three months and eight days.There was resistance noted upon removal.

• 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: 8552109
• MDR Text Key: 144152467
• Report Number: 1820334-2019-00880
• 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,health
• Type of Report: Initial,Followup
• Report Date: 05/20/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/25/2019
• 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?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/16/2019
• Date Manufacturer Received: 04/29/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: IGTCFS-65-1-JUG-CELECT-PT.