MAUDE Adverse Event Report: CORDIS CORPORATION 6F .070 XB 3.5 100CM; CATHETER, PERCUTANEOUS

Catalog Number	67005400
Medical Device Problem Code	Device Markings/Labelling Problem (2911)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	08/20/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Additional information is pending and will be submitted within 30 days upon receipt.
Event or Problem Description
As reported, the 6f.070 x 3.5 x 100 cm vista brite tip guiding catheter (gc) extra back-up (xb) was found out by the physician that the catalogue number was wrong in the package.The actual device in the packaging was 7f guiding catheter (gc) instead of 6f guiding catheter (gc).There was no reported patient injury.Therefore, the procedure was completed by replacing another 6f guiding catheter (gc).Initially, the angiographic examination showed that the coronary artery is with stenosis that needed stent implantation.Then, the equipment who prepare the device gave it to the nurse and then, the nurse confirmed the quantity and opened the packaging one by one.As of note: ¿the hospital has reported this case as an adverse event¿.
Additional Manufacturer Narrative
After further review of additional information received the following sections (pma/510k, if follow-up, what type and adverse event problem) have been updated accordingly.As reported, the 6f.070 x 3.5 x 100 cm vista brite tip guiding catheter (gc) extra back-up (xb) was found out by the physician that the catalogue number was wrong in the package.The actual device in the packaging was 7f guiding catheter (gc) instead of 6f guiding catheter (gc).There was no reported patient injury.Therefore, the procedure was completed by replacing another 6f guiding catheter (gc).Initially, the angiographic examination showed that the coronary artery is with stenosis that needed stent implantation.Then, the equipment who prepare the device gave it to the nurse and then, the nurse confirmed the quantity and opened the packaging one by one.The device was not returned for analysis.Additionally, as the sterile lot number was not available, product history record (phr) reviews could not be performed.Without the return of the device or images for analysis, the reported customer event ¿packaging/pouch/box- labeling incorrect¿ could not be confirmed and the exact root cause could not be determined.Storage or handling factors may contribute to this type of event.However, it is difficult to draw a clinical conclusion between the device and the event based on the limited amount of information provided.According to the instructions for use (ifu), although not intended as a mitigation, ¿store in a cool, dark, dry place.Do not use open or damaged packages.Use prior to the ¿use by¿ date.Do not resterilize.Do not expose to organic solvents.Inspect the guiding catheter before use to verify that its size, shape and condition are suitable for the specific procedure.Descriptions or specifications in cordis printed matter, including this publication, are meant solely to generally describe the product at the time of manufacture and do not constitute any express warranties.¿ without a lot number to conduct a phr review, it is not possible to determine if the reported failure could be related to the manufacturing process.Therefore, no corrective or preventive actions will be taken at this time.Corrected data; device available for evaluation.

• Brand Name: 6F .070 XB 3.5 100CM
• Common Device Name: CATHETER, PERCUTANEOUS
• Manufacturer (Section D): CORDIS CORPORATION; 14201 nw 60th ave; miami lakes FL 33014
• MDR Report Key: 9274005
• Report Number: 9616099-2019-03320
• Device Sequence Number: 19243993
• Product Code: DQY
• UDI-Device Identifier: 20705032020166
• UDI-Public: 20705032020166
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K021593
• 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
• Type of Report: Initial,Followup
• Report Date (Section B): 12/19/2019

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 Catalogue Number: 67005400
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/10/2019
• Supplement Date Received by Manufacturer: 12/11/2019
• Initial Report FDA Received Date: 11/04/2019
• Supplement Report FDA Received Date: 12/19/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: - 6F GUIDE CATHETER