MAUDE Adverse Event Report: CORDIS US CORP. TEMPO; CATHETER, INTRAVASCULAR, DIAGNOSTIC

Catalog Number	451506P0
Medical Device Problem Code	Crack (1135)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/22/2023
Type of Reportable Event	Malfunction
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.
Event or Problem Description
As reported, a 5f multipurpose a1(l) 125cm tempo diagnostic catheter was found to be "broken" in several places outside the patient's body.The procedure was completed by using an unknown "contrast catheter".There was no reported patient injury.The device was intended to be used for a lower extremity arterioplasty.The angiography catheter was found to have several damages after unpacking.The anomalies noted were noted before use.The device was inspected prior to opening the package.The device was intended for use in a diagnostic procedure.The device was stored and prepped per the instructions for use (ifu).There was no difficulty experienced in prepping the device.The user was trained to the device.The device was going to be for treatment of a chronic total occlusion (cto).The device will be returned for evaluation.
Additional Manufacturer Narrative
Complaint conclusion: as reported, a 5f multipurpose a1(l) 125cm tempo diagnostic catheter was found to be "broken" in several places outside the patient's body.The procedure was completed by using an unknown contrast catheter.There was no reported patient injury.The device was intended to be used for a lower extremity arterioplasty.The angiography catheter was found to have several damages after unpacking.The anomalies were noted before use.The device was inspected prior to opening the package.The device was intended for use in a diagnostic procedure.The device was stored and prepped per the instructions for use (ifu).There was no difficulty experienced in prepping the device.The user was trained to the device.The device was going to be used for treatment of a chronic total occlusion (cto).A unit of catheter cath tempo 5f mp a1(l) 125cm was received for analysis.Multiple cracked areas were noted during visual inspection.Outer diameter (od) measurements were taken near the damages and were found within specification.A high magnification visual analysis was executed using the vision system and scratch marks were observed near the damaged sections.The complaint reported by the customer as ¿catheter (body/shaft) - cracked¿ was confirmed since this condition was present on the device.Scratch marks are commonly attributed to an interaction between the affected surface and sharp-edged materials.Therefore, it is possible the interaction that resulted in the scratch marks could be related the cracked conditions.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, ¿store in a cool, dark, dry place.Do not use if package is open or damaged.¿ based on the available information, 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.
Additional Manufacturer Narrative
After further review, section d.4 primary unique device identification (udi) number has been corrected accordingly.

• Brand Name: TEMPO
• Common Device Name: CATHETER, INTRAVASCULAR, DIAGNOSTIC
• Manufacturer (Section D): CORDIS US CORP.; 14021 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 ; santiago troncoso 808; juarez, chihuahua ; 7863138372
• MDR Report Key: 18342348
• Report Number: 9616099-2023-06663
• Device Sequence Number: 12461815
• Product Code: DQO
• UDI-Device Identifier: 10705032008358
• UDI-Public: (01)10705032008358(17)240930(10)18061466
• 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): 08/14/2024

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: 09/30/2024
• Device Catalogue Number: 451506P0
• Device Lot Number: 18061466
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/05/2023
• 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: 11/22/2023
• Supplement Date Received by Manufacturer: 03/06/2024; 08/14/2024
• Initial Report FDA Received Date: 12/17/2023
• Supplement Report FDA Received Date: 03/13/2024; 08/14/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/16/2021
• 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
• Concomitant Medical Products and Therapy/Usage Dates: UNKNOWN.
• Patient Age: 65 YR
• Patient Sex: Unknown
• Patient Weight: 65 KG