MAUDE Adverse Event Report: CORDIS CORPORATION 6F .070 JR 4 100CM; CATHETER, PERCUTANEOUS

Catalog Number 67008200

Device Problem Device Contamination with Chemical or Other Material (2944)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 02/05/2018

Event Type  malfunction  

Manufacturer Narrative

A review of the manufacturing documentation associated with lot (17657037) 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 the 6f guiding catheter (jr 4 100cm) was flushed the technician noticed something abnormal from the end of the catheter.There was no reported patient injury.The product will be returned for analysis.

Manufacturer Narrative

After further review of additional information received the sections have been updated accordingly.As reported, foreign material was confirmed to be inside a sterilized pouch of a tempo.There is no reported patient injury.Additional procedural details were requested but are unknown.The device was not returned for analysis.A device history record (dhr) review of lot 17657037 revealed no anomalies or non-conformances during the manufacturing and inspection processes that can be associated with the reported event.The reported ¿packaging/pouch/box foreign material - in sterile package¿ could not be confirmed as the device was not returned for analysis and/or pictures of the material was not provided.The exact cause of the reported foreign material reported could not be determined.Based on the limited information available for review, it is not possible to determine what factors may have contributed to the reported issue as it is unknown what kind of foreign material the customer may have noticed.As cautioned in the instructions for use, which is not intended as a mitigation, ¿do not use if package is open or damaged.Inspect the guiding catheter before use to verify that its size, shape and condition are suitable for the specific procedure.Inspect the guiding catheter upon removal from packaging to verify that it is undamaged.Warning: do not use a guiding catheter that has been damaged in any way.If damage is detected, replace with an undamaged guiding catheter.Prior to use, flush the guiding catheter lumen with a heparinized saline solution.¿ neither the dhr nor the information available suggests a design or manufacturing related cause for the reported event.Therefore, no corrective/preventive action will be taken at this time.

• Brand Name: 6F .070 JR 4 100CM
• Type of Device: CATHETER, PERCUTANEOUS
• Manufacturer (Section D): CORDIS CORPORATION; 14201 nw 60th ave; miami lakes FL 33014
• MDR Report Key: 7313081
• MDR Text Key: 101514056
• Report Number: 9616099-2018-01960
• Device Sequence Number: 1
• Product Code: DQY
• Combination Product (y/n): N
• PMA/PMN Number: K021593
• 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: 04/03/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/05/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 02/29/2020
• Device Catalogue Number: 67008200
• Device Lot Number: 17657037
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 04/02/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1