MAUDE Adverse Event Report: CORDIS CORPORATION GC 7F 078 XB 3.5; CATHETER, PERCUTANEOUS

Model Number 77805400

Device Problem Device Damaged Prior to Use (2284)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 04/21/2022

Event Type  malfunction  

Event Description

As reported, per feedback from the (b)(6) bonded warehouse, a batch of suspected vista brite tip guiding catheters (gc 7f 078 xb 3.5) was received with a lot of folds in the outer box packaging.It appears that it may be a problem with the printing of the outer box packaging material.It cannot be determined whether it will cause the customer to reject it.There was no patient involvement as the products were not clinically used.Per additional information provided, the damage was noted to the outer product box.The integrity of the sterile pouch was compromised.The products are still in the warehouse and not in the lab.The products have not been clinically used and it is not possible to judge if the damage will have any effect to the products inside the box.Product pictures were provided for review and revealed a total of eleven (11) images of vista brite tip boxes which appear slightly compressed.The products are not being return for evaluation.

Manufacturer Narrative

The device history record (dhr) review of lot 18094911 revealed no anomalies or non-conformances during the manufacturing and inspection processes that could be associated with the reported event.Additional information is pending and will be submitted within 30 days upon receipt.

Manufacturer Narrative

Type of reportable event: per additional information received, it was further clarified that the inner/sterile package of the devices was not affected/opened/altered in any way as it was previously indicated.Based on the additional information received, this event no longer meets the definition of a malfunction that requires submission of a regulatory report.

Event Description

Per additional information received, it was further clarified that the inner/sterile package of the devices was not affected/opened/altered in any way as it was previously indicated.

• Brand Name: GC 7F 078 XB 3.5
• Type of Device: CATHETER, PERCUTANEOUS
• Manufacturer (Section D): CORDIS CORPORATION; 14201 nw 60th avenue; miami lakes FL 33014 2802
• Manufacturer (Section G): CORDIS CORPORATION; 14201 nw 60th avenue; miami lakes FL 33014 2802
• Manufacturer Contact: karla castro ; 14201 nw 60th avenue; miami lakes, FL 33014-2802 ; 7863138372
• MDR Report Key: 14437081
• MDR Text Key: 294797917
• Report Number: 9616099-2022-05641
• Device Sequence Number: 1
• Product Code: DQY
• UDI-Device Identifier: 20705032021873
• UDI-Public: 20705032021873
• Combination Product (y/n): N
• Reporter Country Code: CH
• PMA/PMN Number: K972978
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 05/26/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/19/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 77805400
• Device Catalogue Number: 77805400
• Device Lot Number: 18094911
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 05/25/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/16/2022
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: A
• Patient Sequence Number: 1