MAUDE Adverse Event Report: CORDIS CORPORATION TRAPEASE PERMANENT VENA CAVA FILTER; THROMBECTOMY SYSTEMS (DQO)

Catalog Number 466P306A

Device Problems Material Frayed (1262); Torn Material (3024)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 04/18/2016

Event Type  malfunction  

Manufacturer Narrative

(b)(6).(b)(4).The device will not be returned for analysis.A device history record (dhr) review and additional information are pending and will be submitted within 30 days upon receipt.

Event Description

As reported, when the physician attempted to insert the accessory sheath into the patient, it could not be inserted.Then it was noted that it was frayed.Therefore, a new non-cordis device was used to complete the procedure.There was no reported patient injury.The device will not be returned for analysis.The patient's information was unknown.The target lesion was the femoral artery.The rate of stenosis was unknown.There were no damages or anomalies noted to the trapease and accessory devices, or the packaging.The devices were handled and prepped according to the instructions for use (ifu) a transfemoral approach was made.Vessel characteristics of the access site are unknown, such as if it was at a vein valve, stenosed, or tortuous.A trapease was attempted to be placed.The left femoral vein was punctured (it is unknown if there was difficulty during puncture) and sheath introducer (accessory for the trapease) was attempted to insert but it could not be inserted.The physician tried to insert the sheath but it got frayed.It is unknown what part of the sheath became frayed.It is unknown if the sheath was kinked/bent after attempted use.Therefore the trapease was changed to another new one (non-cordis).The procedure was finished successfully.There was no reported patient injury.The product was clinically used.

Manufacturer Narrative

Complaint conclusion: as reported, when the physician attempted to insert the trapease accessory sheath into the patient, it could not be inserted.Then it was noted that it was frayed.Therefore, a new non-cordis device was used to complete the procedure.There was no reported patient injury.The target lesion was the femoral artery.Vessel characteristics of the access site are unknown, such as if it was at a vein valve, stenosed, or tortuous.There were no damages or anomalies noted to the trapease and accessory devices, or the packaging.The devices were handled and prepped according to the instructions for use (ifu).A transfemoral approach was made.A trapease was attempted to be placed.The left femoral vein was punctured (it is unknown if there was difficulty during puncture) and sheath introducer (accessory for the trapease) was attempted to insert but it could not be inserted.The physician tried to insert the sheath but it got frayed.It is unknown what part of the sheath became frayed.It is unknown if the sheath was kinked/bent after attempted use.The device was not returned for analysis.Review of lot 15886599 revealed no anomalies during the manufacturing and inspection processes that can be associated with the reported complaint.The reported brite tip frayed/split/torn and insertion difficulty could not be confirmed as the device was not returned for analysis.The exact cause could not be determined.Based on the limited information available for review, factors contributing to the difficulty experienced by the customer could not be determined.It is possible that patient factors (skin, vessel characteristics at the insertion site) may have contributed to the difficulty experienced.The ifu states that ¿if strong resistance is met during any stage of the procedure, discontinue the procedure and determine the cause before proceeding.¿ neither the dhr nor the information available for review suggests a design or manufacturing related cause for the events reported; therefore, no corrective action will be taken at this time.

• Brand Name: TRAPEASE PERMANENT VENA CAVA FILTER
• Type of Device: THROMBECTOMY SYSTEMS (DQO)
• Manufacturer (Section D): CORDIS CORPORATION; 14201 nw 60th avenue; miami lakes FL
• Manufacturer Contact: cecil navajas ; circuito interior norte #1820; juarez chihuahua 32580 ; MX 32580 ; 7863133880
• MDR Report Key: 5651163
• MDR Text Key: 45057543
• Report Number: 9616099-2016-00235
• Device Sequence Number: 1
• Product Code: DQO
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K020316
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Health Professional
• Type of Report: Initial,Followup
• Report Date: 04/18/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 04/30/2016
• Device Catalogue Number: 466P306A
• Device Lot Number: 15886599
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 04/18/2016
• Initial Date FDA Received: 05/12/2016
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 06/09/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/13/2013
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1