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

Model Number	67005400
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	02/16/2018
Type of Reportable Event	Malfunction
Event or Problem Description
Additional information was received and the vista brite tip guiding catheter box was severely bent and the device was fractured.There was no patient injury.No other information was provided.
Additional Manufacturer Narrative
Upon receipt of a vista brite tip guiding catheter, it was noted that the box was severely bent, and the device was fractured.The device was not used.There was no patient injury.The device was stored in the cath lab upright.No other information was provided.The product was not returned for analysis.A product history record (phr) review of lot 17730752 revealed no anomalies or non-conformances during the manufacturing and inspection processes that can be associated with the reported events.The events "catheter (body/shaft) cracked - prior to use¿ and ¿packaging/ pouch/box - damaged" reported by the customer were not confirmed since the device was not returned for analysis.Storage and handling factors may have contributed to the reported events.According to the precautions in the instructions for use, which is not intended as a mitigation, ¿store in a cool, dark, dry place.Do not use open or damaged packages.¿ 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 .070 XB 3.5 100CM
• Common Device Name: CATHETER, PERCUTANEOUS
• Manufacturer (Section D): CORDIS CASHEL; cahir road; cashel, tipperary 0000 ; EI 0000
• MDR Report Key: 7412090
• Report Number: 9616099-2018-02048
• Device Sequence Number: 11071637
• Product Code: DQY
• UDI-Device Identifier: 20705032020166
• UDI-Public: 20705032020166
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K021593
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 05/23/2018

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: 09/30/2020
• Device Model Number: 67005400
• Device Catalogue Number: 67005400
• Device Lot Number: 17730752
• Was Device Available for Evaluation?: No
• Distributor Facility Aware Date: 03/12/2018
• Initial Date Received by Manufacturer: 03/12/2018
• Supplement Date Received by Manufacturer: 04/23/2018
• Initial Report FDA Received Date: 04/10/2018
• Supplement Report FDA Received Date: 05/23/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1