MAUDE Adverse Event Report: CORDIS US. CORPORATION 6F .070 XB 3 SH 100CM; CATHETER, PERCUTANEOUS

Model Number	67005300
Medical Device Problem Code	Crack (1135)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/06/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A review of the manufacturing documentation associated with lot 17957100 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 "contents" of a 6f.070 extra back-up 3, 2 side holes (sh) 100cm vista brite tip guiding catheter box have a "defect of fracture" and products are unusable.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: g3, g6, h1, h2, h3, h6, and h10 complaint conclusion: as reported, the "contents" of a 6f.070 extra back-up 3, 2 side holes (sh) 100cm vista brite tip guiding catheter box have a "defect of fracture" and products are unusable.There was no reported patient injury.The device was not returned for evaluation.A product history record (phr) review of lot 17957100 revealed no anomalies or non-conformances during the manufacturing and inspection processes that can be associated with the reported event.The reported ¿catheter-cracked¿ could not be confirmed or further clarified without the return of the device(s).Procedural/handling and or shipping factors may have contributed to the reported event.Information for safety is provided in the products labeling with the intent to make the user aware of the risks and warns the user to not use a guiding catheter that has been damaged in any way.According to the instructions for use (ifu), although not intended as a mitigation of risk, ¿inspect the catheter upon removal from packaging to verify that is undamaged, if damage is detected do not use the catheter and select another one.Based on the information available, the device analysis and the phr review, 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 SH 100CM
• Common Device Name: CATHETER, PERCUTANEOUS
• Manufacturer (Section D): CORDIS US. CORPORATION; 14201 nw 60 avenue; miami lakes FL 33014
• Manufacturer (Section G): CORDIS US. CORPORATION; 14201 nw 60 avenue; miami lakes FL 33014
• Manufacturer Contact: karla castro ; 14201 nw 60 avenue; miami lakes, FL 33014 ; 7863138372
• MDR Report Key: 16522522
• Report Number: 9616099-2023-06317
• Device Sequence Number: 20461598
• Product Code: DQY
• UDI-Device Identifier: 20705032020159
• UDI-Public: (01)20705032020159(17)230630(10)17957100
• Combination Product (Y/N): N
• Initial Reporter Country: TW
• 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: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 03/16/2023

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: 06/30/2023
• Device Model Number: 67005300
• Device Catalogue Number: 67005300
• Device Lot Number: 17957100
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/14/2023
• Supplement Date Received by Manufacturer: 03/16/2023
• Initial Report FDA Received Date: 03/10/2023
• Supplement Report FDA Received Date: 03/16/2023
• Date Device Manufactured: 07/07/2020
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown