MAUDE Adverse Event Report: CORDIS CORPORATION OPTEASE VENA CAVA FILTER; THROMBECTOMY SYSTEMS (DTK)

Catalog Number 466F220AF

Device Problems Material Frayed (1262); Difficult to Insert (1316)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 11/13/2015

Event Type  malfunction  

Manufacturer Narrative

Concomitant products: sheath introducer (4f 11cm terumo), new optease to finish the procedure, radifocus, terumo guidewire (0.035×150cm).(b)(6).The device was returned for analysis, however the engineering evaluation has not yet been completed.Additional information will be submitted within 30 days of receipt.

Event Description

It was reported that when the sheath of a 55cm optease device was attempted to be inserted from the right femoral vein, it was found that the tip of the sheath was frayed and could not be inserted into the vessel from under the skin.The vessel was dilated with a 4f 11cm terumo sheath introducer, and they tried to insert the sheath of the optease, however the insertion angle of the sheath and wire were changed, however the marker tip of the sheath could not be inserted.Therefore, they changed to another optease device to successfully complete the procedure.There was no report of patient injury.The target lesion was the postcaval vein.The lesion was mildly calcified, and moderately tortuous, with a rate of stenosis of 0%.A radifocus terumo guidewire (0.035 x 50cm) was used.The procedure was for filter placement at the postcaval vein.The product was clinically used.The product will be returned for analysis.The device was stored, handled and prepped according to the ifu.There weren't any other anomalies or damages noted to the device or packaging prior to use.

Manufacturer Narrative

Complaint conclusion: it was reported that when the sheath of a 55cm optease device was attempted to be inserted from the right femoral vein, it was found that the tip of the sheath was frayed and could not be inserted into the vessel from under the skin.The vessel was dilated with a 4f 11cm non-cordis sheath introducer, and the user tried to insert the sheath of the optease.However the insertion angle of the sheath and wire were changed, the marker tip of the sheath could not be inserted.Therefore, it was changed to another optease device to successfully complete the procedure.There was no report of patient injury.The target lesion was the postvaval vein.The lesion was mildly calcified, and moderately tortuous, with a rate of stenosis of 0%.A non-cordis guidewire (0.035×150cm) was used.The procedure was for filter placement at the postcaval vein.The device was stored, handled and prepped according to the ifu.There weren't any other anomalies or damages noted to the device or packaging prior to use.The product will be returned for analysis.A non-sterile 55cm optease cannula sheath along with a vessel dilator was received for analysis inside a plastic bag.Per visual analysis, the vessel dilator was received fully introduced into the cannula.Cannula sheath introducer tip was received frayed/ split/ torn damaged.No original packaging was returned for analysis as to determine if complaint condition could be caused due to improper packaging.The vessel dilator was observed kinked damage at the area where cannula damage and vessel damage were detected.No other anomalies were found.Review of lot 15775806 revealed no anomalies during the manufacturing and inspection processes that can be associated with the reported complaint.The reported ¿thrombectomy systems-brite tip (csi/filters) - frayed/split/torn¿ was confirmed due to the condition of cannula sheath distal tip damaged received.However, the exact cause of the frayed/split/torn condition found on the cannula sheath could not be conclusively determined during the analysis.Based on the information available for review, patient or procedural factors may have contributed to the insertion difficulty experienced by the customer (¿insertion angle of the sheath and wire were changed, the marker tip of the sheath could not be inserted¿).Neither the product analysis nor the dhr review suggests that the failure could be related to the manufacturing process; therefore, no corrective action will be taken at this time.

• Brand Name: OPTEASE VENA CAVA FILTER
• Type of Device: THROMBECTOMY SYSTEMS (DTK)
• 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: 5254276
• MDR Text Key: 32465001
• Report Number: 9616099-2015-00608
• Device Sequence Number: 1
• Product Code: DTK
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K034050
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional
• Reporter Occupation: Health Professional
• Type of Report: Initial,Followup
• Report Date: 11/13/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/30/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 11/30/2015
• Device Catalogue Number: 466F220AF
• Device Lot Number: 15775806
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/23/2015
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/17/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/16/2013
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1