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

Catalog Number 466F220A

Device Problems Delivered as Unsterile Product (1421); Unsealed Device Packaging (1444); Packaging Problem (3007)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 05/01/2014

Event Type  malfunction  

Event Description

It was reported that 1 trapease and an optease device were damaged in shipping or production and the sterility of the package was compromised.When the user went to open the filter portion of an optease, a defect was noticed in the plastic but the outside of that box was intact.See related complaint (b)(4)."the box was intake and unopened.The product is stored in the packaged box and was not opened until the procedure.When it was time to open the filter and pusher portion of the product during a procedure, an abrasion nick was noticed on the plastic (the plastic that keeps the product sterile).The abrasion on the package looks to have compromised the sterility.The seal of the inner package was not open and there was no damage to the device itself.

Manufacturer Narrative

(b)(4).Please note that the related event listed in complaint number (b)(4), is reported under manufacturing report number 9616099-2014-00329.This device is available for analysis but has not yet been received.Additional information is pending and will be submitted within 30 days upon receipt.

Manufacturer Narrative

When opening the optease vena cava filter an abrasion was noticed on the plastic that looks to have compromised sterility.The outside of the box was intact and unopened.The product is stored in the packaged box and not opened until the procedure.The seal of the inner package was not open and there was no damage to the device itself.One cordis tms optease retrievable filter outer package box labeled as catalog 466f220a; lot number 15989712 was received for analysis inside a plastic bag.The outer box was received compressed/ crush damaged.Also it was received open at label side of package containing a sterile inner pouch bag with an obturator and an optease filter within its filter case.Per visual analysis, the compress/ crush damage on outer package was observed from middle of box all along up to the outer label open side.The received sterile sealed inner pouch seals were observed intact.However, a couple of scratches/ nick marks on mylar of pouch were found.Nonetheless, scratches/ nick marks on mylar of pouch do not compromise the sterility of product due to no sterile barrier breached found since no pouch perforation observed.No other visual anomalies were found.A review of the manufacturing documentation associated with this lot presented no issues during the manufacturing process that can be related to the reported complaint.The reported complaint by the customer as ¿thrombectomy systems-packaging/pouch/box-damaged-inner package¿ was confirmed due to the compressed/ crush condition of unit as received.However, the reported complaint by the customer as ¿thrombectomy systems-packaging/pouch/box-compromised sterility-sterile barrier breached¿ was not confirmed due to any pouch perforation found.The exact cause of the compressed/ crush damage condition on outer box of unit and the scratches/ nick marks on mylar of pouch could not be conclusively determined during the analysis.Analysis results and dhr review results do not suggest that this kind of damage is related to the manufacturing process.Handling and storage process may contribute to the failures as reported.As additional investigation the tms catheters manufacturing process was reviewed and there were not tools, equipment or product handling that could cause compress/ crush, or other type of damages on the tms outer package and/or inner pouch catheters.In addition, the tms catheters are inspected during manufacturing process for any type of damage; also, several inspections are performed through all the tms catheters assembly process operations.No corrective or preventive actions will be taken at this time, given that the reported failures do not appear to be related to the manufacturing process.The reported complaint by the customer as ¿thrombectomy systems-packaging/pouch/box-damaged-inner package¿ was confirmed due to the compressed/ crush condition of unit as received.However, the reported complaint by the customer as ¿thrombectomy systems-packaging/pouch/box-compromised sterility-sterile barrier breached¿ was not confirmed as no pouch perforation was found.The exact cause of the compressed/ crush damage condition on outer box of unit and the scratches/ nick marks on mylar of pouch could not be conclusively determined.It is unlikely that the device left the manufacturing facility in such a damaged state.It is more likely that the damage occurred during shipping and handling of the device.With the information provided no conclusion can be drawn.Please note that the related event listed in complaint number (b)(4, is reported under manufacturing report number 9616099-2014-00329.

Manufacturer Narrative

The device was returned and the lot number was provided.Manufacture date is not known.Additional information is pending completion of the engineering report.

Manufacturer Narrative

Device history record (dhr) review was conducted and the product met quality requirements for product acceptance.Additional information is pending and will be submitted within 30 days upon receipt.

• Brand Name: OPTEASE VENA CAVA FILTER
• Type of Device: THROMBECTOMY SYSTEMS (DTK)
• Manufacturer (Section D): CORDIS DE MEXICO; circuito interior norte #1820; juarez, chihuahua 3258 0; MX 32580
• Manufacturer (Section G): CORDIS DE MEXICO; circuito interior norte #1820; juarez, chihuahua 3258 0; MX 32580
• Manufacturer Contact: cecil navajas ; miami lakes, FL 33014 ; 63138802
• MDR Report Key: 3817867
• MDR Text Key: 4452625
• Report Number: 9616099-2014-00330
• Device Sequence Number: 1
• Product Code: DTK
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K034050
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 05/01/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/19/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 07/31/2016
• Device Catalogue Number: 466F220A
• Device Lot Number: 15989712
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/02/2014
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 07/11/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1