MAUDE Adverse Event Report: CORDIS CORPORATION TEMPO 4 ANGIOGRAPHY CATHETER; DIAGNOSTIC ENDOVASCULAR CATHETERS (DQO)

Model Number 451430H0

Device Problem Device-Device Incompatibility (2919)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 10/23/2014

Event Type  malfunction  

Event Description

It was reported that the user experienced a fault when using cordis 4f catheter (sim1 and c2) with high pressure connector (kimal) and a medrad contrast injector pump.The incident has occurred three times when performing pre-embolisation check imaging when attempting to connect the catheter to the high pressure connector.When connected we would normally aspirate blood through the catheter into the high pressure connector to ensure no air in the system, however at each time this incident has occurred, the connection at the catheter>high-pressure connector has aspirated air into the connection system.

Manufacturer Narrative

(b)(6).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.Device history record (dhr) review was conducted and the product met quality requirements for product acceptance.This is one of 2 products involved with the reported event and are associated manufacturer report numbers 9616099-2014-00753 and 9616099-2014-00754.

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.

Manufacturer Narrative

It was reported that the user experienced a fault when using cordis 4f catheter with high pressure connector (non-cordis) and a medrad contrast injector pump.The incident has occurred three times when performing pre-embolisation check imaging when attempting to connect the catheter to the high pressure connector.When connected we would normally aspirate blood through the catheter into the high pressure connector to ensure no air in the system, however at each time this incident has occurred, the connection at the catheter high-pressure connector has aspirated air into the connection system.(b)(4): the device was not returned for analysis.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 ¿luer hub - incompatibility/fit-with injector tubing/iv tubing¿ was not confirmed as the device was not retuned for analysis.The exact cause could not be determined.Based on the information available for review, factors contributing to the difficulty experienced by the customer could not be determined.Neither the information available nor the manufacturing records review suggests a design or manufacturing related cause; therefore, no corrective/preventive action will be taken.This is one of 2 products involved with the reported event and are associated manufacturer report numbers 9616099-2014-00753 and 9616099-2014-00754.

• Brand Name: TEMPO 4 ANGIOGRAPHY CATHETER
• Type of Device: DIAGNOSTIC ENDOVASCULAR CATHETERS (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: 4258219
• MDR Text Key: 16863861
• Report Number: 9616099-2014-00754
• Device Sequence Number: 1
• Product Code: DQO
• Combination Product (y/n): N
• Reporter Country Code: UK
• PMA/PMN Number: K973401
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Company Representative
• Reporter Occupation: Health Professional
• Type of Report: Initial,Followup,Followup
• Report Date: 12/15/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/18/2014
• 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 Model Number: 451430H0
• Device Catalogue Number: 451430H0
• Device Lot Number: 15950092
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/15/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/26/2013
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1