MAUDE Adverse Event Report: CORDIS CORPORATION CATH 5F INFINITI TL 3DRC 100CM; DIAGNOSTIC CARDIOLOGY CATHETER (DQO)

Model Number 534576T

Device Problems Delivered as Unsterile Product (1421); Unsealed Device Packaging (1444); Tear, Rip or Hole in Device Packaging (2385); Device Packaging Compromised (2916); Packaging Problem (3007)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 09/24/2014

Event Type  malfunction  

Event Description

Upon opening the outer packaging, it was noted the inner packaging of three 5f 100cm infiniti tl catheters were ripped and the sterility was compromised.One of the three catheters was found separated in two pieces.The devices were stored in the cath lab according to the ifu.The devices will be returned for analysis.No further information is available.

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.This is one of three products involved with the reported event and the associated manufacturer report numbers are: 9616099-2014-00645, 9616099-2014-00646, & 9616099-2014-00647.

Manufacturer Narrative

Additional information was provided by the sales representative indicating that the devices will not be returned for analysis.This is one of three products involved with the reported event and the associated manufacturer report numbers are: 9616099-2014-00645, 9616099-2014-00646, & 9616099-2014-00647.Complaint conclusion: upon opening the outer packaging, it was noted the inner packaging of three 5f 100cm infiniti tl catheters were ripped and the sterility was compromised.One of the three catheters was found separated in two pieces.The devices were stored in the cath lab according to the ifu.The device was not returned for analysis.Review of the manufacturing records noted no anomalies that may have contributed to this issue.The reported packaging/pouch/box compromised sterility-sterile barrier breached for the three units and on reported as body/shaft separated prior to use could not be confirmed as the devices were not returned for analysis.The exact cause could not be determined.Based on the limited information available for review, clinical factors contributing to the difficulty experienced by the customer could not be determined.The dhr does not suggest a design or manufacturing related cause for this issue; therefore, no corrective action will be taken at this time.

Manufacturer Narrative

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.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.This is one of three products involved with the reported event and the associated manufacturer report numbers are: 9616099-2014-00645, 9616099-2014-00646, & 9616099-2014-00647.

• Brand Name: CATH 5F INFINITI TL 3DRC 100CM
• Type of Device: DIAGNOSTIC CARDIOLOGY CATHETER (DQO)
• 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: 4162109
• MDR Text Key: 4868208
• Report Number: 9616099-2014-00647
• Device Sequence Number: 1
• Product Code: DQO
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K970854
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: User Facility
• Reporter Occupation: Health Professional
• Type of Report: Initial,Followup,Followup
• Report Date: 09/24/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/10/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 06/30/2017
• Device Model Number: 534576T
• Device Catalogue Number: 534576T
• Device Lot Number: 17051199
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/11/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/18/2014
• Type of Device Usage: Initial
• Patient Sequence Number: 1