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

Catalog Number	451435H0
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/22/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Additional information is pending and will be submitted within 30 days upon receipt.
Event or Problem Description
As reported, during the thoracic aortic stent implantation surgery, the tip-end imaging ring of a 4f headhunter 1 (h1) 100cm tempo diagnostic catheter detached and fell off inside the patient's body.There were no reports of patient injury.The device will be returned for evaluation.
Event or Problem Description
As reported, during the thoracic aortic stent implantation surgery, the tip-end imaging ring of a 4f headhunter 1 (h1) 100cm tempo diagnostic catheter detached and fell off inside the patient's body.The yellow tip was lost during the surgery, and the physician is really worried about this patient since the tip is lost.There were no reports of patient injury.Multiple attempts to obtain supplemental information were made; however, additional event details were not provided.The device will be returned for evaluation.
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
Additional information is pending and will be submitted within 30 days upon receipt.
Additional Manufacturer Narrative
Complaint conclusion: as reported, during the thoracic aortic stent implantation surgery, the tip-end imaging ring of a 4f headhunter 1 (h1) 100cm tempo diagnostic catheter detached and fell off inside the patient's body.The yellow tip was lost during the surgery, and the physician is really worried about this patient since the tip is lost.There were no reports of patient injury.Multiple attempts to obtain supplemental information were made; however, more event details were not provided.A 5-second procedural clip shows the aortic arch and ascending aorta with a stent graft in place.The guidewire¿s proximal segment courses through the aortic arch, exits via the right subclavian artery, and its distal tip resides in the right common carotid artery.A focal radiopaque object presumed to be the detached distal tip is visible in the right subclavian artery, just outside the stent graft.The catheter shaft is not visualized, supporting the impression of tip separation.The clip offers no evidence of the underlying root cause.Three pictures related to the reported malfunction on the product ¿cath tempo 4f h1 100cm¿ was attached in this complaint file.In the first picture a non-sterile catheter with the separated brite tip is seen.The unit is being compared with a sterile unit to point out that the brite tip is missing.In the second picture a closer view of the separated area is seen.Some elongations in the separated edges are visible.In the third picture a pouch with the label to the front is seen, where the catalog number 451-435h, lot 18369144, and expiration date 2027-08-31 among other product information can be read.No other outstanding details were observed in the attached pictures.A non-sterile cath tempo 4f h1 100cm catheter was received coiled inside a clear plastic bag for evaluation.Upon unpacking, visual inspection revealed a separation at the brite tip/distal tip approximately 100 cm from the hub, with a dark discoloration at the separation border.Additionally, the catheter body exhibited a kinked or bent condition located approximately 70 cm from the distal end.No other damage or anomalies were visually observed.Dimensional analysis of the body and distal tip near the damaged areas confirmed that both the inner and outer diameters were within acceptable limits.Sem imaging of the distal separation identified micro-elongation features and material transfer at the separation site, suggesting localized plastic deformation due to tensile loading.White particulates observed near the fracture region were consistent with tungsten residue.Eds analysis confirmed the presence of tungsten in both the complaint and reference samples, while sodium and potassium were detected only in the complaint sample, likely due to procedural or decontamination-related exposure.The dark discoloration was determined to be consistent with normal manufacturing processes and not attributed to post-manufacturing factors.The observed separation was attributed to mechanical stress that exceeded the material's yield strength.The reported ¿brite tip/distal tip-separated¿ was observed during the complaint investigation.The micro-elongation features and material transfer at the separation site suggest localized plastic deformation due to tensile loading.However, the source of the excessive tensile force cannot be found.Manipulating the device against resistance is a possible cause.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 of making the user aware of the risks.According to the instructions for use (ifu), although not intended as a mitigation of risk, ¿to prevent damage to the catheter tip during removal from the package, grasp the hub and gently withdraw the catheter treat all 4f catheters and smaller french sizes with ultimate care.The performance of these products may be impaired if not properly and cautiously handled during unpacking and preparation.¿ based on the available information, there is no evidence to suggest 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: 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 FL 33014
• Manufacturer Contact: karla castro ; santiago troncoso 808; juarez, chihuahua ; 7863138372
• MDR Report Key: 22208135
• Report Number: 9616099-2025-00965
• Device Sequence Number: 20761798
• Product Code: DQO
• UDI-Device Identifier: 10705032007986
• UDI-Public: (01)10705032007986(17)270831(10)18369144
• 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,Followup
• Report Date (Section B): 08/13/2025

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 Catalogue Number: 451435H0
• Device Lot Number: 18369144
• 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: 05/22/2025
• Supplement Date Received by Manufacturer: 06/13/2025; 07/15/2025; 08/11/2025
• Initial Report FDA Received Date: 06/14/2025
• Supplement Report FDA Received Date: 07/08/2025; 08/11/2025; 08/13/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 09/19/2024
• 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: CORDIS TEMPO; TERUMO LOACH GUIDEWIRE (150CM)
• Outcome Attributed to Adverse Event: Life Threatening
• Patient Age: 60 YR
• Patient Sex: Male