MAUDE Adverse Event Report: CORDIS CORPORATION CATH F5 INF PIG145 110CM 6SH; DIAGNOSTIC CATHETER

Model Number N/A

Device Problem Partial Blockage (1065)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 09/19/2017

Event Type  malfunction  

Manufacturer Narrative

This device is available but has not yet been received.A device history record review was performed and showed that these lots of products met all requirements per the applicable manufacturing quality plan.Additional information is pending and will be submitted within 30 days upon receipt.

Event Description

The pigtail catheter was removed from packaging and placed on the sterile procedure table.When the catheter was flushed it was noted that the pigtail did not have side holes, the pigtail catheter only had one end hole.The catheter never came into contact with the patient.The labeling on the catheter packaging states the catheter should have 6 side holes.The label and the catheter will be returned for investigation.

Manufacturer Narrative

The device was received and section d10 was updated.The completed engineering report will be submitted within 30 days upon receipt.

Manufacturer Narrative

The pigtail catheter was removed from packaging and placed on the sterile procedure table.When the catheter was flushed it was noted that the pigtail did not have side holes, the pigtail catheter only had one end hole.The catheter never came into contact with the patient.The labeling on the catheter packaging states the catheter should have 6 side holes.An image of a cordis catheter was received for analysis; however, per visual analysis of the received picture the body shaft tip of catheter could not be observed confirm the complaint.Later, one cath f5 inf pig145 110cm 6sh diagnostic catheter from this complaint was received for evaluation coiled inside a plastic bag.Per visual analysis of the device, neither side holes nor side holes¿ marks were observed on the catheter.No other anomalies found.A meeting was held with pet.The device was reviewed and the complaint was confirmed.The unit was thoroughly inspected and no side holes were visible on the unit.A device history record (dhr) review of lot 17693395 revealed no anomalies or non-conformances during the manufacturing and inspection processes that can be associated with the reported event.The reported ¿catheter (body/shaft) no side holes during prep¿ was confirmed through analysis of the returned device.The exact cause of the failure could not be conclusively determined during analysis; however, it was considered manufacturing-related.Therefore, a risk assessment has been initiated to assess this issue.

• Brand Name: CATH F5 INF PIG145 110CM 6SH
• Type of Device: DIAGNOSTIC CATHETER
• Manufacturer (Section D): CORDIS CORPORATION; 14201 nw 60th ave,; miami lakes 33014
• Manufacturer (Section G): CORDIS CORPORATION; 14201 nw 60th ave; miami lakes FL 33014
• Manufacturer Contact: karla castro ; 14201 nw 60th ave; miami lakes, FL 33014
• MDR Report Key: 6940264
• MDR Text Key: 90099780
• Report Number: 9616099-2017-01504
• 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: company representative,health
• Reporter Occupation: Health Professional
• Type of Report: Initial,Followup,Followup
• Report Date: 11/21/2017

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: 06/30/2020
• Device Model Number: N/A
• Device Catalogue Number: 534552S
• Device Lot Number: 17693395
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Distributor Facility Aware Date: 09/21/2017
• Initial Date Manufacturer Received: 09/21/2017
• Initial Date FDA Received: 10/11/2017
• Supplement Dates Manufacturer Received: 10/16/2017; 11/17/2017
• Supplement Dates FDA Received: 10/23/2017; 11/21/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/28/2017
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1