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

Model Number	67005400
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/01/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
This device is not available for testing and evaluation.Additional information is pending and will be submitted within 30 days upon receipt.
Event or Problem Description
As reported, when using 6f.070 3.5 100cm vista brite tip extra back-up (xb) guiding catheter presented breakage in two parts.Patient had a medical history of heart disease.The device was not used in the patient.The device did not separate inside the patient.The device was not resterilized.Two breaks were observed in the product before use.Abnormalities were noted when removed from the package.There was no reported patient injury.The device will be returned for evaluation.
Additional Manufacturer Narrative
After further review of additional information received the following sections have been updated accordingly g4,g6,h1,h2,h3 and h6.As reported, two breaks were noted on a 6f.070 3.5 100cm vista brite tip extra back-up (xb) guiding catheter.The breaks were observed when the device was removed from the package.The catheter was not used in the patient.The patient had a medical history of heart disease.The device was not resterilized.There was no reported patient injury.The product was not returned for analysis.A review of the product history report (phr) for lot 17987570 revealed no anomalies during the manufacturing and inspection processes that can be associated with the reported complaint.Without the return of the device for analysis, the reported customer complaint, catheter (body/shaft)- separated - during prep, could not be confirmed and no determination of possible contributing factors could be made.Storage conditions (incorrect temperature, lighting, humidity), handling and/or shipping may have contributed to this issue.Although not intended as a mitigation of risk, information for safety is provided in the products labeling with the intent to make the user aware of the risks.According to the instructions for use (ifu), ¿store in a cool, dark, dry place.Do not use if package is open or damaged.Exposure to temperatures above 54°c (130¿) may damage the catheter.¿ users are trained to inspect for kinks and bends, or other signs of damage prior to and during use.Any product with damage is not to be used.With the limited information provided, it is not possible to draw a conclusion about a clinical relationship between the device and the event.Based on the phr review and the information available, there is no indication that the event is related to the device design or manufacturing process.Therefore, no preventative or corrective actions will be taken at this time.

• Brand Name: 6F .070 XB 3.5 100CM
• Common Device Name: CATHETER, PERCUTANEOUS
• Manufacturer (Section D): CORDIS CORPORATION; 14201 nw 60 avenue; miami lakes FL 33014
• MDR Report Key: 12280352
• Report Number: 9616099-2021-04763
• Device Sequence Number: 2733289
• Product Code: DQY
• UDI-Device Identifier: 20705032020166
• UDI-Public: 20705032020166
• Combination Product (Y/N): N
• Initial Reporter Country: BR
• PMA/510(K) Number: K021593
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (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): 08/18/2021

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: 10/31/2023
• Device Model Number: 67005400
• Device Catalogue Number: 67005400
• Device Lot Number: 17987570
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 07/14/2021
• Supplement Date Received by Manufacturer: 08/06/2021
• Initial Report FDA Received Date: 08/05/2021
• Supplement Report FDA Received Date: 08/18/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1