MAUDE Adverse Event Report: COOK INC UNKNOWN

Catalog Number UNKNOWN

Device Problem Failure to Align (2522)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 01/13/2010

Event Type  malfunction  

Manufacturer Narrative

Common name & product code: unavailable as the device lot number, rpn, and gpn are unknown.Occupation: attorney.Pma/510(k) number: unavailable as the device lot number, rpn, and gpn are unknown.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, during a procedure to place an inferior vena cava filter in a patient undergoing gastric bypass surgery, a cook tulip inferior vena cava filter tilted upon deployment of the device.Lidocaine was used for local anesthetic.The patient was placed under conscious sedation, using fentanyl and versed, for one hour.Vital signs remained stable throughout the procedure.Access was obtained in the right internal jugular vein, using an 18 gauge needle and ultrasound guidance.An unknown 0.035 inch wire and unknown 8.5 french delivery sheath were advanced to the inferior vena cava.Imaging demonstrated normal anatomy.The tulip filter was then deployed.Reportedly, the filter tilted "significantly" upon deployment, with the filter hook abutting the caval wall.The user decided to remove the filter and the delivery set was initially exchanged for an unknown loop snare; however, the tip of the filter would not engage the loop snare, despite multiple attempts.The snare was then exchanged for a cook retrieval set and the filter was removed without difficulty.Another cook filter was then placed, which was later found to have tilted and perforated the vena cava.The complaint on the second filter has been previously reported under reference number (b)(4).

Event Description

No new patient or event information to report.

Manufacturer Narrative

Blank fields on this form indicate the information is unknown, unchanged, or unavailable.Description of event: as reported, during a procedure to place an inferior vena cava filter in a patient undergoing gastric bypass surgery, a cook tulip inferior vena cava filter tilted upon deployment of the device.Lidocaine was used for local anesthetic.The patient was placed under conscious sedation, using fentanyl and versed, for one hour.Vital signs remained stable throughout the procedure.Access was obtained in the right internal jugular vein, using an 18 gauge needle and ultrasound guidance.An unknown 0.035 inch wire and unknown 8.5 french delivery sheath were advanced to the inferior vena cava.Imaging demonstrated normal anatomy.The tulip filter was then deployed.Reportedly, the filter tilted "significantly" upon deployment, with the filter hook abutting the caval wall.The user decided to remove the filter and the delivery set was initially exchanged for an unknown loop snare; however, the tip of the filter would not engage the loop snare, despite multiple attempts.The snare was then exchanged for a cook retrieval set and the filter was removed without difficulty.Another cook filter was then placed, which was later found to have tilted and perforated the vena cava.The complaint on the second filter has been previously reported under reference number (b)(4).Investigation ¿ evaluation a document based investigation was performed including a review of complaint history, documentation, drawings, the instructions for use, manufacturing instructions, and quality control data.The complaint device was not returned; therefore, no physical examinations could be performed.However, a document based investigation evaluation was performed.There is no evidence to suggest the product was made out of specification.The lot number of the device is not known; accordingly, a review of the device history record could not be conducted.The instructions for use (ifu), provides the following information to the user related to the reported failure mode: intended use: the product is intended for use by physicians trained and experienced in diagnostic and interventional techniques a review of relevant manufacturing documents was conducted.It was concluded that the device aspect in question was visually/functionally inspected by quality control and no related gaps in production or processing controls were noted.No product was returned and no imaging was provided.Therefore, based on the information provided only, it would be inappropriate to speculate at what may or may not have caused the filter to tilt ¿significantly upon deployment, with the filter hook abutting the caval wall.¿ per the quality engineering risk assessment, no further action is warranted.Cook will continue to monitor this device via the complaints database for similar complaints.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: UNKNOWN
• Manufacturer (Section D): COOK INC; 750 daniels way; bloomington IN 47404
• MDR Report Key: 10349765
• MDR Text Key: 207542029
• Report Number: 1820334-2020-01398
• Device Sequence Number: 1
• Product Code: DTK
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: other
• Type of Report: Initial,Followup
• Report Date: 12/01/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/31/2020
• 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
• Date Manufacturer Received: 11/20/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: GUNTHER TULIP JUGULAR VENA CAVA FILTER SET
• Patient Age: 46 YR
• Patient Weight: 91