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

Catalog Number 466F220AJ

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

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 11/18/2014

Event Type  malfunction  

Event Description

It was reported that during filter placement of a 55cm optease device, that the tip of the 6f accessory sheath introducer had gotten frayed prior to the procedure.Therefore, the physician stopped using it, and a new optease device was used instead.The product was clinically used.There was no report of patient injury, and the procedure was finished successfully.The device will be returned for analysis.The device was stored, handled and prepped according to the ifu.There was no damage noted to the inner or outer packaging.There were no kinks or other anomalies observed with the device prior to or during use.There was no difficulty or resistance/friction while advancing the deployment sheath to deploy.

Manufacturer Narrative

Complaint conclusion: it was reported that the tip of the 6f accessory sheath introducer became frayed prior to the procedure.The physician stopped using it and a new optease device was used.The device was stored, handled and prepped according to the ifu.There was no damage noted to the inner or outer packaging.There were no kinks or other anomalies observed with the device prior to or during use.There was no difficulty or resistance/friction while advancing the deployment sheath.There was no report of patient injury, and the procedure was finished successfully.A non-sterile optease retrievable filter cannula, a non-sterile obturator, a non-sterile vessel dilator and a non-sterile storage tube with filter loaded were received for analysis inside a plastic bag.Per visual analysis the distal tip of the cannula was found frayed/split/torn.No other issues were found.The damaged area was inspected under vision system and evidences of elongations were found at the surroundings areas of separation.A review of the manufacturing documentation associated with lot presented no issues during the manufacturing process that can be related to the reported complaint.Review of lot 17087019 revealed no anomalies during the manufacturing and inspection processes that can be associated with the reported complaint.No units were rejected during the final assembly of this lot.No other issues were noted that were considered potentially related to the reported complaint.The complaint reported by the customer ¿brite tip/distal tip - frayed/split/torn¿ was confirmed by the condition of the received sheath introducer.The cause of this frayed/split/torn reported by the customer during procedure could not be conclusively determined during the analysis.However, it does not appear to be product manufacturing related since evidences of elongations were found at the surroundings areas of separation.Elongation is a common characteristic of pieces which were stretched/pulled until separation.Handling and procedural factors may contribute to the csi tip frayed/split/torn condition found.With the information available and without films of the event it is not possible to draw a clinical conclusion between the device and the reported event.However, procedural factors may have contributed to the reported event.(b)(6).

• 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: 4428362
• MDR Text Key: 5283784
• Report Number: 9616099-2015-00018
• 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: Health Professional
• Reporter Occupation: Health Professional
• Type of Report: Initial
• Report Date: 01/05/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/16/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 07/31/2017
• Device Catalogue Number: 466F220AJ
• Device Lot Number: 17087019
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/03/2014
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/05/2015
• Date Device Manufactured: 08/29/2014
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1