MAUDE Adverse Event Report: CORDIS CORPORATION OPTEASE RETRIEVAL CATHETER; THROMBECTOMY SYSTEMS (DTK)

Catalog Number 466C210F

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

Patient Problem No Patient Involvement (2645)

Event Date 09/02/2015

Event Type  malfunction  

Manufacturer Narrative

Please note that the gender of the patient is unknown.(b)(4).(b)(6).The device was returned for analysis, but the engineering report is not available.However, it will be provided within 30 upon receipt.A device history record (dhr) review and additional information are pending and will be submitted within 30 days upon receipt.This is one of three products involved with the reported event and the associated manufacturer report numbers are 9616099-2015-00494, 9616099-2015-00495, and 9616099-2015-00496.

Event Description

It was reported by the surgeon that there was a kink on three (3) 10fr optease retrieval catheters noted during prep of the same procedure.It was also reported there was unknown damage noted to the packaging which compromised the integrity of the sterile pouch.However, it was reported that there were no damages noted to the packaging prior to use.There was no patient involvement.The sales rep advised that the distributor moved their warehouse.The catheters were put in a temporary location.However, for a procedure to retrieve an optease catheter, it was noted that 3 optease retrieval catheters were kinked during prep of the same procedure.The location of the kinks were not reported.There was no reported difficulty removing the products from the packaging.There was no other product issue noted at the account after the procedure or prior to shipping for inspection.The devices will be returned for analysis.

Manufacturer Narrative

This is one of three products involved with the reported event and the associated manufacturer report numbers are 9616099-2015-00494, 9616099-2015-00495, and 9616099-2015-00496.Complaint conclusion: it was reported by the surgeon three 10fr optease retrieval catheters were noted to be kinked during prep for a single procedure.It was also reported there was unknown damage noted to the packaging which compromised the integrity of the sterile pouch; however, no damages were noted prior to use.There was no patient involvement.It was noted that the distributor moved the warehouse and catheter were put in a temporary location.For the procedure to retrieve an optease ivc filter, it was noted that three optease retrieval catheters were kinked during prep of the same procedure.The location of the kinks were not reported.There was no reported difficulty removing the products from the packaging.There was no other product issue noted at the account after the procedure or prior to shipping for inspection.One non-sterile unit 10fr optease retrieval catheter was received coiled in a plastic bag.Per visual analysis one kinked condition was found at 34 cm from distal end.The components of packing not were received for analysis.No other anomalies were found.Dimensional analysis was conducted for reference purposes only.The outer diameter of the received optease catheter was measured at different locations within the length of the complaint units.Similarly, the od/id was measured near to kinked condition and no anomalies were found.A review of the manufacturing documentation associated with lot 17181150 revealed no anomalies during the manufacturing and inspection processes.The reported ¿packaging/pouch/box - compromised sterility¿ and ¿packaging/pouch/box- damaged¿ was not confirmed as the product packaging was not received for analysis.The exact cause of the difficulty experienced by the customer could not be determined.The reported ¿catheter (body/shaft) ¿ kinked¿ was confirmed during through analysis of the returned devices.Based on the limited information available for review, handling factors during storage and/or device preparation may have contributed to kinking of the devices.Neither the event description nor the product analysis suggest a design or manufacturing related cause for the difficulties experienced by the customer; therefore, no corrective action will be taken at this time.

• Brand Name: OPTEASE RETRIEVAL CATHETER
• 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: 5157331
• MDR Text Key: 28566886
• Report Number: 9616099-2015-00495
• Device Sequence Number: 1
• Product Code: DTK
• Combination Product (y/n): N
• Reporter Country Code: CH
• PMA/PMN Number: UNK
• 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: Followup
• Report Date: 09/08/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/16/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 12/31/2017
• Device Catalogue Number: 466C210F
• Device Lot Number: 17181150
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/21/2015
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/27/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/10/2015
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1