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

Model Number G53008

Device Problem Detachment of Device or Device Component (2907)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 05/02/2019

Event Type  malfunction  

Manufacturer Narrative

This report includes information known at this time.A follow-up report will be submitted should additional relevant information become available.

Event Description

It was reported that during an ivc filter retrieval procedure the cloversnare¿ 4-loop vascular retriever experienced a tuohy-borst hub separation.The filter was successfully retrieved but could not be removed through the hub of the device.At this point the physician was able to successfully remove the retrieval set as well as the 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 information regarding event details, patient anatomy and overall outcome has been requested, but is not available at this time.

Manufacturer Narrative

This report includes information known at this time.A follow-up report will be submitted should additional relevant information become available.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 16may2019 which provided the ivc filter was not a cook device.It was another manufacturer's retrievable filter which had been in place approximately one year and was removed via the internal jugular route.

Manufacturer Narrative

Blank fields on this form indicate the information is unknown, unavailable, or unchanged.Investigation ¿ evaluation: reviews of the dimensional verification, complaint history, device history record, instructions for use (ifu), quality control, specification, and a functional test & visual inspection of the returned device as well as an inspection of an unused device were conducted during the investigation.The visual inspection of the returned package confirmed that the entire vrs-6.0-90 device was returned used with extensive biological matter.The pin vise handle was separated from the cloversnare.The gray inner catheter had been withdrawn leaving the cloversnare inside the two coaxial blue sheaths.The dilator was also returned.The gray inner catheter could be easily advanced over the cloversnare wire into the inner sheath.The pin vise handle could be tightened securely onto the cloversnare wire.The inner and outer sheaths could not be separated.The hubs of the sheaths could be unscrewed, but the sheath tubings were stuck together at an unknown location.The distal end hole of the inner sheath was damaged, likely from the argon filter.The outer sheath¿s outer diameter was.156¿.Because they could not be separated, the coaxial sheath system was cut 33.1cm from the hub of the outer sheath.The proximal end of the inner sheath could be removed through the outer sheath.The distal end of the inner sheath could not be removed from the distal end of the outer sheath.The distal coaxial sheath system was again cut 22.9cm from the distal tip of the outer sheath.The proximal inner sheath could be easily removed from the proximal outer sheath.Pliers were used to remove the distal inner sheath from the distal out sheath.There was extensive dried biomatter between the sheaths.The cut portions of the inner sheath¿s outer diameter measured.125¿.There was a slight kink 2.5cm from the distal tip of the inner sheath, where the distal tip of the outer sheath aligned.When the most distal section of the inner sheath was reinserted into the most distal section of the outer sheath, there was no resistance.The outer sheath¿s distal tip accepted a.127¿ pin gauge with little resistance.Additionally, a document based investigation evaluation was performed.There is no evidence to suggest the product was not made to specifications.A review of the device history record showed no nonconforming events which could contribute to this failure mode.It should also be noted there were no other reported complaints for this lot number.Furthermore, reviews of the manufacturer¿s instructions and quality control procedures were conducted, and no gaps were discovered.Moreover, an ifu is provided with this device stating all necessary warnings, precautions, indications, contraindications as well as step by step instructions on the use of the device.Based on the information provided and the examination of the returned product, investigation has concluded that a root cause for this event could not be established.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.

Event 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
• Type of Device: MMX DEVICE, PERCUTANEOUS RETRIEVAL
• Manufacturer (Section D): COOK INC; 750 daniels way; bloomington IN 47404
• MDR Report Key: 8617224
• MDR Text Key: 145512165
• Report Number: 1820334-2019-01140
• Device Sequence Number: 1
• Product Code: MMX
• UDI-Device Identifier: 10827002530086
• UDI-Public: (01)10827002530086(17)220412(10)9665296
• 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,Followup
• Report Date: 06/27/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/16/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 04/12/2022
• Device Model Number: G53008
• Device Catalogue Number: VRS-6.0-90
• Device Lot Number: 9665296
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/16/2019
• Date Manufacturer Received: 06/25/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: ARGON ELITE RETRIEVABLE FILTER.