MAUDE Adverse Event Report: WILLIAM COOK EUROPE COOK CELECT PLATINUM NAVALIGN UNISET VENA CAVA FILTER SET; DTK FILTER, INTRAVASCULAR, CARDIOVASCULAR

Catalog Number IGTCFS-65-2-UNI-CELECT-PT

Device Problem Difficult to Advance (2920)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 03/23/2020

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Blank fields on this form indicate the information is unknown or unavailable.Similar to device under pma/510(k) k171712.Investigation is still in progress.

Event Description

When the physician pushed the filter introducer (preloaded with filter) in the guide sheath, he felt resistance and couldn't pass smoothly through the guide sheath, so he strengthened in pushing, and he found ivc filter hook perforate the sheath, but no damage on vessel.He removed the guide sheath and found tortuous common iliac vein (civ) anatomy make the sheath kinked.He replaced with a new one and finished the procedure.Patient did not require any additional procedures due to this occurence.

Event Description

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

Manufacturer Narrative

Manufacturers ref# (b)(4).Summary of investigational findings: the investigation is based on the event description and the returned device.It was reported that the sheath kinked and that the filter introducer with filter perforated the sheath.Device was replaced.The complete device was returned for investigation - the filter still loaded to the femoral introducer and advanced all the way through the introducer sheath.The system was still locked.The introducer sheath was accordion-like between 49mm and 113mm from the distal end and was curved 500mm from same.Also, a hole was noted 49-51mm from distal tip and a kink 129mm from same.The hook of the filter was slightly straightened and appeared a bit more open that specified, likely because it caught the sheath wall, when retrieved back through the penetration and into the sheath lumen.Based on these findings and the reported ¿strengthened in pushing¿ when resistance was felt, it is suggested that the sheath was kinked during advancement through the tortuous anatomy and following the filter hook penetrated the sheath wall and created the hole, if forcefully advanced through the kinked sheath.Under normal conditions the sheath is strong enough to accomplish the procedure, but it may kink if advanced through tortuous anatomy and the filter may be prone to exceed the sheath wall if advanced through a kinked sheath.There are adequate controls in place to ensure the device was manufactured to specifications.It was assessed that because no non-conformances were detected, there is evidence that the dhr was fully executed.In addition, no other lot related complaints have been received from the field.It is therefore concluded that there is no evidence that nonconforming product exists in house or in field.Cook medical will continue to monitor for similar events.This report is required by the fda under 21cfr 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: COOK CELECT PLATINUM NAVALIGN UNISET VENA CAVA FILTER SET
• Type of Device: DTK FILTER, INTRAVASCULAR, CARDIOVASCULAR
• Manufacturer (Section D): WILLIAM COOK EUROPE; sandet 6; bjaeverskov 4632 ; DA 4632
• MDR Report Key: 9961160
• MDR Text Key: 198519289
• Report Number: 3002808486-2020-00402
• Device Sequence Number: 1
• Product Code: DTK
• UDI-Device Identifier: 10827002345048
• UDI-Public: (01)10827002345048(17)220930(10)E3904015
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 07/07/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/15/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 09/30/2022
• Device Catalogue Number: IGTCFS-65-2-UNI-CELECT-PT
• Device Lot Number: E3904015
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/30/2020
• Date Manufacturer Received: 07/06/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1