MAUDE Adverse Event Report: CORDIS CORPORATION GC 9F .098 STR 55CM; CATHETER, PERCUTANEOUS

Model Number	598943P
Medical Device Problem Codes	Device Contamination with Chemical or Other Material (2944); Manufacturing, Packaging or Shipping Problem (2975)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	01/14/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A review of the manufacturing documentation associated with lot 17818155 presented no issues during the manufacturing process that can be related to the reported event.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 or Problem Description
As reported, the 47 units that were sitting in our warehouse were released and 25 of them were found to be defective (particulate matter).The integrity of the sterile pouch was not compromised.The actual product was not damaged.There was no damage to the outer product box.The 25 units will be returned for analysis.
Additional Manufacturer Narrative
As reported, the customer noticed particles being inside sterile packaging of 25 devices.The integrity of the sterile pouch was not compromised.The actual product was not damaged.There was no damage to the outer product box.No other information was reported.Twenty-five devices were returned for analysis.25 sterile units, corresponding to cat.No.598943p, (gc 9f.098 str 55cm) lot no.17818155, were received for analysis.Angel hair/slivers were detected adhered to the tabs of the mounting cards except in some instances in which a loose angel air/sliver was detected after removing the device from the packaging, however, angel hair/slivers can be loosened by excessive handling of the devices.Based on the shape and location where the angel hair/slivers were detected, the root cause of this failure can be attributed to the tab cutting process during mounting card manufacturing process.No particle adhered to the catheter was detected (internally or externally) during all the inspections performed.A review of the manufacturing documentation associated with lot 17818155 was performed and a risk assessment has been opened to further investigate this issue.The event reported as ¿packaging/pouch/box-foreign material - in sterile package¿ was confirmed since visual analysis confirmed presence of angel hair/slivers on the devices received.This material is part of the mounting card material and was not cleanly cut.The inner pouches were fully reviewed, and no loose pieces of cardboard were found.According to the safety information in the instructions for use ¿inspect the guiding catheter before use to verify that its size, shape and condition are suitable for the specific procedure.¿ the product analysis suggests that the event experienced by the customer could be related to the manufacturing process; therefore, a corrective/preventive action will be taken at this time.
Additional Manufacturer Narrative
Recall number: z-1198-2019.

• Brand Name: GC 9F .098 STR 55CM
• Common Device Name: CATHETER, PERCUTANEOUS
• Manufacturer (Section D): CORDIS CORPORATION; 14201 nw 60 avenue; miami lakes FL 33014
• MDR Report Key: 8325489
• Report Number: 9616099-2019-02698
• Device Sequence Number: 11197474
• Product Code: DQY
• UDI-Device Identifier: 20705032019092
• UDI-Public: 20705032019092
• Combination Product (Y/N): N
• PMA/510(K) Number: K925131
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other Health Care Professional
• Remedial Action: Recall
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 04/26/2019

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
• Operator of Device: Health Professional
• Device Expiration Date: 09/30/2021
• Device Model Number: 598943P
• Device Catalogue Number: 598943P
• Device Lot Number: 17818155
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/23/2019
• Initial Date Received by Manufacturer: 01/14/2019
• Supplement Date Received by Manufacturer: 02/25/2019; 04/22/2019
• Initial Report FDA Received Date: 02/11/2019
• Supplement Report FDA Received Date: 03/19/2019; 04/26/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1