MAUDE Adverse Event Report: CORDIS CORPORATION TEMPO; CATHETER, INTRAVASCULAR, DIAGNOSTIC

Catalog Number	451543H0
Medical Device Problem Code	Device Contamination with Chemical or Other Material (2944)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/10/2023
Type of Reportable Event	Malfunction
Event or Problem Description
As reported, there was a hair inside the packaging of a 5f cobra 2 (c2) 100cm tempo angiographic catheter.There were no reports of patient injury.The packaging of the catheter was not opened and the sterile pouch was not received opened.The device was never used or reshelved.The condition was noted upon initial receipt of device.The device will be returned for evaluation.
Additional Manufacturer Narrative
A review of the manufacturing documentation associated with lot 10106175 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.
Additional Manufacturer Narrative
This device is available for analysis, but the engineering report is not yet available.However, it will be submitted within 30 days upon receipt.Additional information is pending and will be submitted within 30 days upon receipt.
Additional Manufacturer Narrative
After further review of additional information received the following sections have been updated accordingly: d2, g1, g3, g6, h1, h2, h3, h6, and h10.As reported, there was a hair inside the packaging of a 5f cobra 2 (c2) 100cm tempo angiographic catheter.There were no reports of patient injury.The packaging of the catheter was not opened, and the sterile pouch was not received opened.The device was never used or reshelved.The condition was noted upon initial receipt of device.A sterile unit of ¿cath tempo 5f c2 100cm¿ was received for analysis.The pouch seals were intact, and the sterility was not compromised.During visual inspection, a long hair was observed inside of the packaging.The unit was inspected with a vision system to obtain a magnified image and confirmed the presence of a hair inside the pouch.Ftir analysis results of the foreign material were suggestive of hair.A product history record (phr) review of lot 18155302 revealed no anomalies or non-conformances during the manufacturing and inspection processes that can be associated with the reported event.The complaint reported by the customer as ¿packaging/pouch/box-foreign material in sterile package-movable particle¿ was confirmed.One hair was found inside the sealed pouch.Users are trained to inspect for signs of damage prior to and during use.Any product with damage is not to be used.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), although not intended as a mitigation of risk, ¿do not use if package is open or damaged.¿ per analysis of the returned device, the hair located inside the sterile packaging was found to be manufacturing related and an investigation was initiated to address this issue.

• Brand Name: TEMPO
• Common Device Name: CATHETER, INTRAVASCULAR, DIAGNOSTIC
• Manufacturer (Section D): CORDIS CORPORATION; 14201 nw 60 avenue; miami lakes, florida 33014
• Manufacturer (Section G): CORDIS US CORP.; 14201 nw 60 avenue; miami lakes, florida 33014
• Manufacturer Contact: karla castro ; 14201 nw 60 avenue; miami lakes, florida 33014 ; 7863138372
• MDR Report Key: 16860713
• Report Number: 9616099-2023-06480
• Device Sequence Number: 20319440
• Product Code: DQO
• UDI-Device Identifier: 10705032008662
• UDI-Public: (01)10705032008662(17)250930(10)18155302
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K973401
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 08/29/2023

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: 09/30/2025
• Device Catalogue Number: 451543H0
• Device Lot Number: 18155302
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/10/2023
• Supplement Date Received by Manufacturer: 04/25/2023; 08/23/2023
• Initial Report FDA Received Date: 05/03/2023
• Supplement Report FDA Received Date: 05/17/2023; 08/29/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/14/2022
• 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