MAUDE Adverse Event Report: CORDIS CORPORATION 6F .072 JR 4 100CM; CATHETER, PERCUTANEOUS

Catalog Number	67208200
Medical Device Problem Code	Device Markings/Labelling Problem (2911)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	12/26/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A review of the manufacturing documentation associated with lot 17750510 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 or Problem Description
As reported, the box indicated the device was 6f.072 jr 4 100cm adroit guiding catheter but inside there was a jr4 sh guiding catheter instead.The device was used on the patient.The device was stored as per the labeling and was opened in a sterile field.The device was not used a chronic total occlusion (cto).There was no damage to the outer packaging.The seal of the sterile pouch inside was opened, prior to noticing the different device and the actual product was not damaged.The package was opened before the procedure.The procedure was completed successfully and without patient injury.
Additional Manufacturer Narrative
During an unknown procedure, the box indicated the device was a 6f.072 jr 4 100cm adroit guiding catheter but inside there was a jr4 sh guiding catheter instead.The device was used on the patient.The device was stored as per the labeling and was opened in a sterile field.The device was not used a chronic total occlusion (cto).There was no damage to the outer packaging.The seal of the sterile pouch inside was opened, the actual product was not damaged.The package was opened before the procedure.The procedure was completed successfully and without patient injury.No other information was reported.The device and packaging were not returned for analysis.A product history record (phr) review of lot 17750510 revealed no anomalies or non-conformances during the manufacturing and inspection processes that can be associated with the reported event.The label reconciliation form and samples of the labels attached to the router were reviewed and no issues were found that may be related to the reported event.The reported, ¿packaging/pouch/box labeling incorrect ¿ device¿ could not be confirmed as the device and packaging were not returned for analysis.The exact cause could not be determined.As per the precautions in the instructions for use (ifu), which is not intended as a mitigation, ¿do not use open or damaged packages.Inspect the guiding catheter before use to verify that its size, shape and condition are suitable for the specific procedure.¿ neither the phr nor the information available suggests a design or manufacturing related cause for the reported events; therefore, no corrective/preventive action will be taken at this time.

• Brand Name: 6F .072 JR 4 100CM
• Common Device Name: CATHETER, PERCUTANEOUS
• Manufacturer (Section D): CORDIS CORPORATION; 14201 nw 60th avenue; miami lakes FL 33014
• MDR Report Key: 8265340
• Report Number: 9616099-2019-02661
• Device Sequence Number: 11157561
• Product Code: DQY
• UDI-Device Identifier: 20705032065402
• UDI-Public: 20705032065402
• Combination Product (Y/N): N
• Initial Reporter Country: SN
• PMA/510(K) Number: K131225
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign,health professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 02/05/2019

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: 12/31/2020
• Device Catalogue Number: 67208200
• Device Lot Number: 17750510
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 12/26/2018
• Supplement Date Received by Manufacturer: 01/28/2019
• Initial Report FDA Received Date: 01/21/2019
• Supplement Report FDA Received Date: 02/05/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1