MAUDE Adverse Event Report: CORDIS CORPORATION CATH 5F INFINITI TL PIG155 110; DIAGNOSTIC CARDIOLOGY CATHETER (DQO)

Catalog Number 534554S

Device Problem Detachment Of Device Component (1104)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 12/09/2014

Event Type  malfunction  

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 the engineering report is not yet available.However, it will be submitted within 30 days upon receipt.

Event Description

The report received from the sales representative indicated that a 5f 110cm angled pigtail infiniti diagnostic catheter being used for a lv injection procedure separated at the hub.As they were injecting contrast thru the catheter at a rate below 1200 psi, the hub separated from the catheter at the proximal end.The product separation occurred outside the patient's body and the patient was not harmed.There was enough contrast injected that a second catheter was not used.The product will be returned for inspection.No lesion was involved.The device was not resterilized.There were no reported anomalies noted when the device was removed from the package.There were no anomalies noted during prep.There was no difficulty withdrawing the device from the patient.

Manufacturer Narrative

The gender of the patient is unknown.This device is available for analysis but the engineering report is not yet available.However, it will be submitted within 30 days upon receipt.

Manufacturer Narrative

Complaint conclusion: the report received indicated that a 5f 110cm angled pigtail infiniti diagnostic catheter being used for a lv injection procedure separated at the hub.As they were injecting contrast thru the catheter at a rate below 1200 psi, the hub separated from the catheter at the proximal end.The product separation occurred outside the patient's body and the patient was not harmed.There was enough contrast injected that a second catheter was not used.The device was not resterilized.There were no reported anomalies noted when the device was removed from the package.There were no anomalies noted during prep.There was no difficulty withdrawing the device from the patient.The device was returned for analysis.A non-sterile diagnostic cath f5 inf pig155 110cm 6sh was received for analysis coiled inside a plastic bag.Per visual analysis, the hub was found separated from body shaft of catheter.Unit¿s separated pieces were inspected under vision system.The separated edges on the received proximal end of catheter body shaft looks as if force had caused the separation on unit.No other anomalies were found.The catheter body shaft proximal end od and id were measured near to the separation condition and results were found within specification.The received unit was sem, x-rayed and cross-sectioned in order to inspect the molded condition of the hub and body shaft proximal end.Elongation and remnants of body shaft in the walls of luer hub were observed.As per sem, x-ray and cross section results the hub presented evidence of remnants of body inside of the hub.The elongations observed presented evidence of a plastic deformation as a product of an application of a tension force that induced the separation.No other anomalies were found during the 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.Review of lot 17130443 revealed no anomalies during the manufacturing and inspection processes that can be associated with the reported complaint.The complaint reported by the customer as ¿diagnostic cardiology catheter-luer hub-separated-during use¿ was confirmed during analysis due to catheter body shaft separated from hub received condition.However, the exact cause of the body shaft separated from hub condition found on the diagnostic catheter could not be conclusively determined during the analysis.Based on the information available for review, factors contributing to this condition could not be determined.However, elongation at the point of separation may suggest that force was applied to the device.Analysis results and dhr review do not suggest that this damage is related to the manufacturing process.Therefore, no corrective action will be taken at this time.

• Brand Name: CATH 5F INFINITI TL PIG155 110
• 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: 4361146
• MDR Text Key: 20854307
• Report Number: 9616099-2014-00822
• 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: Health Professional,Company Representative
• Reporter Occupation: Health Professional
• Type of Report: Initial,Followup,Followup
• Report Date: 01/14/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/24/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 09/30/2017
• Device Catalogue Number: 534554S
• Device Lot Number: 17130443
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/18/2014
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/14/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/07/2014
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1