MAUDE Adverse Event Report: WILLIAM COOK EUROPE GUNTHER TULIP VENA CAVA FILTER RETRIEVAL SET; DTK FILTER, INTRAVASCULAR, CARDIOVASCULAR

Model Number	G13287
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	05/09/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(6).This report includes information known at this time.A follow-up report will be submitted at the conclusion of the investigation or, when additional relevant information becomes available.
Event or Problem Description
It was reported, a (b)(6) male was undergoing an inferior vena cave filter removal (cook celect platinum) when the filter got stuck (endothelialized in 3 months).The snare loop from the gunther tulip vena cava filter retrieval set "broke" after it was engaged with the filter hook.The filter was not able to be removed.There has been no effect on the patient; however part of the loop remained with the filter hook after it broke.
Event or Problem Description
Additional information was received on (b)(6) 2019, noting that the physician has no plans to retrieve the segment portion of the loop.
Additional Manufacturer Narrative
This report includes information known at this time.A follow-up report will be submitted at the conclusion of the investigation or, when additional relevant information becomes available.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.
Additional Manufacturer Narrative
Blank fields on this form indicate the information is unknown, unchanged, or unavailable.Corrected fields: b5, d3, f14.The device associated with this report was manufactured by william cook europe, not cook incorporated.The complaint file will be transferred to william cook europe and cook, inc.Will not send any additional follow-up reports regarding this event.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 or Problem Description
Correction: the device associated with this report was manufactured by william cook europe, not cook incorporated.The complaint file will be transferred to william cook europe and cook, inc.Will not send any additional follow-up reports regarding this event.

• Brand Name: GUNTHER TULIP VENA CAVA FILTER RETRIEVAL SET
• Common Device Name: DTK FILTER, INTRAVASCULAR, CARDIOVASCULAR
• Manufacturer (Section D): WILLIAM COOK EUROPE; sandet 6; bjaeverskov 4632 IN 47404
• MDR Report Key: 8636696
• Report Number: 1820334-2019-01280
• Device Sequence Number: 1875545
• Product Code: DTK
• UDI-Device Identifier: 00827002132870
• UDI-Public: (01)00827002132870(17)210604(10)E3734492
• Combination Product (Y/N): N
• Initial Reporter Country: IN
• PMA/510(K) Number: K073374
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 12/12/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 06/04/2021
• Device Model Number: G13287
• Device Catalogue Number: GTRS-200-RB
• Device Lot Number: E3734492
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/28/2019
• Initial Date Received by Manufacturer: 05/09/2019
• Supplement Date Received by Manufacturer: 05/24/2019; 05/24/2019
• Initial Report FDA Received Date: 05/23/2019
• Supplement Report FDA Received Date: 06/17/2019; 12/12/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Age: 26 YR
• Patient Weight: 75