MAUDE Adverse Event Report: COOK INC UNKNOWN; DTK FILTER, INTRAVASCULAR, CARDIOVASCULAR

Catalog Number UNKNOWN

Device Problem Break (1069)

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

Event Date 09/14/2021

Event Type  malfunction  

Manufacturer Narrative

Device name: bird's nest ivc filter.This report includes information known at this time.A follow up report will be submitted should additional relevant information become available.

Event Description

As reported, at an unknown point a wire on a bird's nest filter was found to be fractured.The filter was initially placed in 1997.The patient had asked about the device being removed, but was told that it was not an issue and was left in place.They have not experienced any symptoms.The patient had not experienced any adverse effects.

Manufacturer Narrative

Correction- attached files, g2.The attached user medwatch report was incidentally omitted from the initial report.Additional information: attached files, g2.The attached fda medwatch report was received on 29sep2021.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

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

Manufacturer Narrative

Event summary as reported, at an unknown point a wire on a bird's nest filter was found to be fractured.The filter was initially placed in 1997.The patient had asked about the device being removed but was told that it was not an issue and was left in place.They have not experienced any symptoms.The patient had not experienced any adverse effects.Correction: a5 - ethnicity: information was included in the medwatch form 3500 report but inadvertently omitted from previous reports.Investigation - evaluation: reviews of the instructions for use, manufacturing instructions, and quality control procedures of the device were conducted during the investigation.No device was returned for investigation.No lot number was provided, reviews of the device history record and complaint history could not be conducted.There is no evidence of nonconforming devices from the complaint lot in house or in the field.A review of relevant manufacturing documents was conducted.It was concluded that the device aspect in question was functionally inspected by quality control and no notable gaps in production or processing controls were noted.There is no indication that a design or process related failure mode contributed to the reported event.Sufficient inspection activities are in place to identify this failure mode prior to distribution.The device instructions for use provide the following information related to this failure mode: warnings: if severe resistance is me when advancing the wire guide, then retract the wire guide and choose a different approach.Do not rotate the expanded filter hooks inside the vena cava.Doing so may compromise the performance of the filter.Excessive force should not be exerted during placement of the filter.Precautions: -filter fracture is a known potential complication of vena cava filter.Both symptomatic and asymptomatic events have been reported.Fracture of a filter hook/hook wire strut can be due to repetitive motion on a filter hook/hook wire strut in an unusual stressed position.Among other causes, filter fracture may be associated with a filter hook penetrating/perforating the ivc, a filter hook being caught in a side branch (e.G., renal vein), excessive force or manipulations near an implanted filter (e.G., a surgical procedure in the vicinity of a filter) and (or) procedures that involve other devices being passed through an in situ filter.It has been reported that retrieval of a fractured filter or filter fragments using endovascular techniques is possible.Based on the available information, cook has concluded that a component failure unrelated to manufacturing or design deficiencies contributed to this incident.Cook will continue monitoring of similar complaints and has 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

Patient demographics was inadvertently omitted from previous reports.Patient ethnicity is not hispanic/latino and their race is white.

• Brand Name: UNKNOWN
• Type of Device: DTK FILTER, INTRAVASCULAR, CARDIOVASCULAR
• 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: 12546151
• MDR Text Key: 273767658
• Report Number: 1820334-2021-02237
• Device Sequence Number: 1
• Product Code: DTK
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K161218
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Health Professional,User Facility
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 12/14/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/29/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: UNKNOWN
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/30/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Age: 54 YR
• Patient Sex: Male
• Patient Weight: 88 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White