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

Model Number G53008

Device Problem Difficult to Remove (1528)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 05/28/2022

Event Type  Injury  

Manufacturer Narrative

(b)(6).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

As reported, during retrieval of an unknown inferior vena cava (ivc) filter, a cloversnare 4-loop vascular retriever's snare became "jailed" on a leg of the filter.A photo provided by the customer shows what appears to be the snare loop entangled with one or more filter legs/tines.The ivc was opened by a vascular surgeon, and the filter was removed.Additional information has been requested.

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 26aug2022.A cook celect filter was being retrieved at the time of the event.The filter, which had been in place for two months, was slightly tilted.One of the filter legs was slightly embedded in the caval wall; however, the filter was not damaged prior to removal, and no other devices were used to attempt filter retrieval.The surgeon opened the inferior vena cava, and the filter and snare were removed from the patient.

Manufacturer Narrative

Summary of event: as reported, during retrieval of a cook celect inferior vena cava (ivc) filter, a cloversnare 4-loop vascular retriever's snare became "jailed" on a leg of the filter.The filter, which had been in place for two months, was slightly tilted.One of the filter legs was slightly embedded in the caval wall; however, the filter was not damaged prior to removal, and no other devices were used to attempt filter retrieval.A photo provided by the customer shows what appears to be the snare loop entangled with one or more filter legs/tines.The vascular surgeon opened the inferior vena cava, and the filter and snare were removed from the patient.Investigation evaluation: reviews of the complaint history, device history record, drawing, instructions for use (ifu), manufacturing instructions, and quality control procedures were conducted during the investigation.The complaint device was not returned to cook for investigation.Photos provided by the customer show that the loop was caught on a filter leg, not on the filter hook as intended for filter retrieval.A document-based investigation evaluation was performed.No related non-conformances were found, and there have been no other reported complaints for this lot number.The product ifu cautions that excessive force should not be used to manipulate or retrieve foreign objects, and instructs that manipulation requires fluoroscopic control.The information provided upon review of the dmr, dhr, ifu, and review of supplied images provides evidence the device was manufactured to specification.There is no evidence of non-conforming devices in-house or in the field.Cook has concluded that sufficient inspection activities are in place to identify this failure mode prior to distribution.Based on the information provided and the results of the investigation, cook has concluded that a user or procedural issue contributed to this event.The ifu warns against use of excessive force during removal of objects and instructs the user to use fluoroscopy.An image provided by the customer shows that the hook of the filter was not captured with the snare.The risk analysis for this failure mode was reviewed and no additional escalation was required.The appropriate personnel have been notified and cook will continue to monitor for similar events.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

No additional information has been received since the last report was submitted.

• 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
• Manufacturer (Section G): COOK INC.; 750 daniels way; bloomington IN 47404
• Manufacturer Contact: jason crouch ; 750 daniels way; bloomington, IN 47404 ; 8123392235
• MDR Report Key: 14687319
• MDR Text Key: 294922831
• Report Number: 1820334-2022-01054
• Device Sequence Number: 1
• Product Code: MMX
• UDI-Device Identifier: 10827002530086
• UDI-Public: (01)10827002530086(17)240930(10)NS14247876
• Combination Product (y/n): N
• PMA/PMN Number: K112185
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Health Professional,User Facility,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 11/08/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/14/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: G53008
• Device Catalogue Number: VRS-6.0-90
• Device Lot Number: NS14247876
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/12/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/30/2021
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: GTRS-200-RB; HPWA-35-180; IGTCFS-65-2-UNI-CELECT-PT; JCD10.0-38-20; JCD12.0-38-20; THSCF-35-260-1.5-ROSEN-BH
• Patient Outcome(s): Required Intervention
• Patient Sex: Male