MAUDE Adverse Event Report: CORDIS CORPORATION OUTBACK RE-ENTRY CATHETER; CTO CATHETER SYSTEMS (DQY)

Catalog Number OTB42120

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 07/09/2015

Event Type  malfunction  

Event Description

The customer reported that when the user pulled the device off the shelf in the lab, the inner sterile pouch of the outback cto catheter was not sealed properly.There was no reported damage or tear to the packaging, only that the product fell out of the inner package as if it was not correctly sealed.The integrity of the inner sterile pouch was compromised.The product was stored according to the ifu guidelines.The device was not used in the patient.The device is available for return.

Manufacturer Narrative

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

Complaint conclusion.A report was received that a customer pulled an outback ltd off the shelf in the lab and found that its¿ inner sterile pouch was not properly sealed and fell out.They stated that the integrity of the inner sterile pouch was compromised.The site further reported that they had stored the product according to the instructions for use (ifu) and did not note any damage or tears in the packaging.The device was not used in a patient.The device was returned for evaluation in its¿ inner tray inside of its¿ original inner pouch.Visual analysis noted that the bottom seal was opened.Seal marks were noted on the crystalline material of the received pouch.No other issue was found.The open pouch seal was inspected under a microscope and the seal marks were observed on the crystalline material of the received pouch.Sem analysis of the open seal of the pouch revealed that the pouch crystalline material layer surface of both analyzed samples presented similar characteristics with marks of the tyvek surface.This finding was suggestive that the pouch had been properly sealed at a certain time.A review of the manufacturing records for this lot of products revealed that it met specification prior to release.The reported ¿packaging/pouch/box - compromised sterility-seal open¿ event was confirmed based on the condition of product as it was received for analysis.Shipping and handling factor may be contributed to the reported failure.According to the product ifu, the device should not be used if the package is opened or damaged.It is difficulty to draw a clinical conclusion between the device and the event based on the information available.However the product analysis revealed evidence that there may have been shipping and handling issues that may have contributed to the reported event.Neither the dhr review nor the product analysis suggests that the reported failures could be related to the manufacturing process of the unit.Therefore, no corrective actions will be taken.

Manufacturer Narrative

The involved product was returned for analysis.The engineering report is not yet available.However, it will be submitted within 30 days upon receipt.A review of the manufacturing documentation associated with lot 17192393 revealed no anomalies during the manufacturing and inspection processes that can be associated with the reported complaint.

• Brand Name: OUTBACK RE-ENTRY CATHETER
• Type of Device: CTO CATHETER SYSTEMS (DQY)
• 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: 4945923
• MDR Text Key: 19988800
• Report Number: 9616099-2015-00322
• Device Sequence Number: 1
• Product Code: DQY
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K043534
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: User Facility,user facility
• Reporter Occupation: Health Professional
• Type of Report: Initial
• Report Date: 07/14/2015

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: 01/31/2017
• Device Catalogue Number: OTB42120
• Device Lot Number: 17192393
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/18/2015
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 07/14/2015
• Initial Date FDA Received: 07/28/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/18/2015
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1