MAUDE Adverse Event Report: COOK INC

Device Problem Material Separation (1562)

Patient Problem No Code Available (3191)

Event Date 05/24/2018

Event Type  Injury  

Manufacturer Narrative

Common name & product code: unavailable as the device lot number, rpn, and gpn are unknown.Pma/510(k) number: unavailable as the device lot number, rpn, and gpn are unknown.(b)(4).This report includes information known at this time.A follow-up report will be submitted should additional relevant information become available.(b)(4); mw5077533, recvd 11jun2018.

Event Description

A report was received via an hhs/fda sus report reference: mw5077533, a gunther tulip ivc filter which had been implanted in 2005 fractured.Although the sus report indicates a serious injury occurred requiring medical intervention, no further information was provided.Additional information regarding event details, patient anatomy, medical intervention, and outcome, product information and complaint device availability, has been requested, but is not available at this time.

Manufacturer Narrative

Blank fields on this form indicate the information is unknown, unavailable, or unchanged.Investigation evaluation.A review of the complaint history, instructions for use (ifu), and specifications was conducted during the investigation.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 not made to specifications.The lot number of the device is not known; accordingly, a review of the device history record could not be conducted.Based on the information provided, no product returned and the results of our investigation, a definitive root cause could not be determined.We will continue to monitor for similar complaints.Per the 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.- attachment: [pr231193_hhs fda sus_mw5077533_recvd 11jun2018.Pdf].

Event Description

No additional information regarding the patient and/or event has been received since the previous medwatch report was sent.Refer to section h10 for investigation findings.

• Manufacturer (Section D): COOK INC; 750 daniels way; bloomington IN 47404
• MDR Report Key: 7673434
• MDR Text Key: 113529532
• Report Number: 1820334-2018-01915
• 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: health professional,other
• Type of Report: Initial,Followup
• Report Date: 10/04/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/10/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 09/25/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: ASKU; ASKU
• Patient Outcome(s): Required Intervention