MAUDE Adverse Event Report: CORDIS CORPORATION CATH F5.2+ JR4 100CM; CATHETER, INTRAVASCULAR, DIAGNOSTIC

Catalog Number 533552

Device Problems Partial Blockage (1065); Device Contamination with Chemical or Other Material (2944)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 06/05/2018

Event Type  malfunction  

Manufacturer Narrative

A review of the manufacturing documentation associated with lot (17716956) presented no issues during the manufacturing process that can be related to the reported event.Additional information is pending and will be submitted within 30 days upon receipt.

Event Description

As reported, when flushing a resistance was felt, then they tried to introduce the wire and then it came out with this sticky "stuff" at the end.The catheter was not yet in the patient.There was no reported patient injury.The device was stored and handled per the instructions for use (ifu).There was no damage noted to the package.There were no anomalies noted to the device when it was taken out of the packaging.The integrity of the sterile pouch was not compromised.There were no anomalies noted when the device was taken out of the package.There were no visible signs of device/package damage prior to use.The device was prepped according to instructions for use (ifu).The device did not prep normally as when flushing the catheter, some sticky stuff was seen on the tip.The difficulty was encountered while preparing the device.There were no kinks/bends noted on the device.The catheter was not inserted into the patient.The product was not clinically used as it was only prepared, but not used.The device will be return for analysis.

Manufacturer Narrative

During prep, when flushing the cath f5.2+ jr4 100cm resistance was felt.When attempting to introduce the guide wire, ¿sticky stuff" came out of the end of the catheter.The catheter was not yet in the patient.There was no reported patient injury.The device was stored and handled per the instructions for use (ifu).There were no anomalies noted to the device when it was taken out of the packaging.The integrity of the sterile pouch was not compromised.There were no visible signs of device/package damage prior to use.The device was prepped according to instructions for use (ifu).The device did not prep normally as when flushing the catheter, some ¿sticky stuff¿ was noted on the tip.There were no kinks/bends noted on the device.The product was not clinically used as it was only prepared.The device was returned for analysis.One non-sterile unit of cath f5.2+ jr4 100cm was received coiled inside a plastic bag along with a file that contained two pictures of the complaint unit.Per visual analysis of the received device no anomalies or damages were noted; however, the received pictures show a yellowish foreign material.Per functional analysis, a lab sample syringe was attached to the hub of received catheter and it was properly flushed, no foreign material was noted; then, a 0.038¿ emerald guide wire lab sample was inserted through the received catheter guide wire lumen and no foreign matter was found.X-ray was not performed since no obstructions were found during the functional analysis.A review of the manufacturing documentation associated with lot 17716956 was performed and no issues were noted that were related to the reported complaint.The phr review does not suggest that the event experienced by the customer could be related to the manufacturing process.The event reported by the customer as ¿catheter (body/shaft) ¿ obstructed - during prep¿ was not confirmed since no obstruction was found during the functional analysis.The cause of the event reported by the customer could be related to the foreign material that was noted during the review of the received pictures.The event reported by the customer as ¿catheter (body/shaft) - foreign material - during prep¿ was confirmed since foreign material was noted during the review of the received pictures.However, the foreign material noted on the received pictures was not returned for analysis, neither microscopic nor any other analysis could be made.Hence, the root cause of the noted contamination could not be conclusively determined solely based on the attached picture review.According to the instructions for use, which is not intended as a mitigation, ¿before use, flush all devices entering a blood vessel with sterile heparinized saline or a similar isotonic solution.Store in a cool, dark, dry place.Do not use if package is open or damaged.Exposure to temperatures above 54° c (130° f) may damage the catheter.¿ neither the phr review results nor picture review or product analysis results provide enough evidence to confirm that these issues could be manufacture related.Therefore, no corrective or preventive actions will be taken at this time.

• Brand Name: CATH F5.2+ JR4 100CM
• Type of Device: CATHETER, INTRAVASCULAR, DIAGNOSTIC
• Manufacturer (Section D): CORDIS CORPORATION; 14201 nw 60th ave; miami lakes FL 33014
• MDR Report Key: 7673245
• MDR Text Key: 113533800
• Report Number: 9616099-2018-02235
• Device Sequence Number: 1
• Product Code: DQO
• Combination Product (y/n): N
• PMA/PMN Number: K862244
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional
• Type of Report: Initial,Followup
• Report Date: 07/23/2018

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: 09/30/2018
• Device Catalogue Number: 533552
• Device Lot Number: 17716956
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/21/2018
• Initial Date Manufacturer Received: 06/12/2018
• Initial Date FDA Received: 07/10/2018
• Supplement Dates Manufacturer Received: 07/09/2018
• Supplement Dates FDA Received: 07/23/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1