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

Catalog Number	SRD6892
Medical Device Problem Codes	Crack (1135); Material Puncture/Hole (1504)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/03/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Additional information is pending and will be submitted within 30 days upon receipt.
Event or Problem Description
As reported, there were multiple holes throughout the length of a 5f 125cm 135-degree vertebral (vert) tempo diagnostic catheter.The damage to the catheter was observed during a cerebral angiogram, and the catheter was in the right m2 vessel when the damage was observed.There were no reported injuries to the patient.The device was stored and prepped per the instructions for use (ifu) and there was no damage to the device packaging.The vessel characteristics were non-calcified, non-tortuous, and had 0% stenosis.The device was never placed in an acute bend during its use in the patient, and there was no difficulty removing the device from the patient.The device is available for evaluation.
Additional Manufacturer Narrative
After further review of additional information received the following sections have been updated accordingly: b4, g3, g6, h1, h2, h3, h6, and h11.A review of the manufacturing documentation associated with lot 18161245 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, there were multiple holes throughout the length of a 5f 125cm 135-degree vertebral (vert) tempo diagnostic catheter.The damage to the catheter was observed during a cerebral angiogram, and the catheter was in the right m2 vessel when the damage was observed.There were no reported injuries to the patient.The device was stored and prepped per the instructions for use (ifu) and there was no damage to the device packaging.The vessel characteristics were non-calcified, non-tortuous, and had 0% stenosis.The device was never placed in an acute bend during its use in the patient, and there was no difficulty removing the device from the patient.The device was not received for evaluation.
Additional Manufacturer Narrative
Complaint conclusion: as reported, there were multiple holes throughout the length of a 5f 125cm 135-degree vertebral (vert) tempo diagnostic catheter.The damage to the catheter was observed during a cerebral angiogram, and the catheter was in the right m2 vessel when the damage was observed.There were no reported injuries to the patient.The device was stored and prepped per the instructions for use (ifu) and there was no damage to the device packaging.The vessel characteristics were non-calcified, non-tortuous, and had 0% stenosis.The device was never placed in an acute bend during its use in the patient, and there was no difficulty removing the device from the patient.The product was not returned for analysis.A review of the manufacturing documentation associated with lot 18161245 presented no issues during the manufacturing process that can be related to the reported event.Based on the limited information provided, it is not possible to draw a conclusion about a clinical relationship between the device and the event.Without the return of the device for analysis, the reported customer complaint " catheter (body/shaft) puncture/cut" could not be evaluated.With the limited information provided, without the return of the device, and with no procedural films, the cause of the reported event could not be determined.It is possible that factors related to the procedure, handling, and/or patient anatomy contributed to the reported event.All catheters require torquing, which is a dynamic process once it enters the patient due to external factors such as temperature, time of exposure in body, individual patient anatomical structures, storage conditions, and operator technique in torquing and manipulating the catheter.If a catheter does not move as expected, the operator is trained to stop and investigate the cause before continuing to avoid further damage to the catheter, such as a puncture/cut/break in material integrity.Based on the device history record 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.
Additional Manufacturer Narrative
After further review of additional information received the following sections have been updated accordingly: this device is available for analysis, but the engineering report is not yet available.However, it will be submitted within 30 days upon receipt.
Event or Problem Description
As reported, there were multiple holes throughout the length of a 5f 125cm 135-degree vertebral (vert) tempo diagnostic catheter.The damage to the catheter was observed during a cerebral angiogram, and the catheter was in the right m2 vessel when the damage was observed.There were no reported injuries to the patient.The device was stored and prepped per the instructions for use (ifu) and there was no damage to the device packaging.The vessel characteristics were non-calcified, non-tortuous, and had 0% stenosis.The device was never placed in an acute bend during its use in the patient, and there was no difficulty removing the device from the patient.The device has now been returned.
Additional Manufacturer Narrative
After further review of additional information received the following sections have been updated accordingly: b4, b5, g3, g6, h1, h2, h3, h6, and h11.Complaint conclusion: as reported, there were multiple holes throughout the length of a 5f 125cm 135-degree vertebral (vert) tempo diagnostic catheter.The damage to the catheter was observed during a cerebral angiogram, and the catheter was in the right m2 vessel when the damage was observed.There were no reported injuries to the patient.The device was stored and prepped by the instructions for use (ifu) and there was no damage to the device packaging.The vessel characteristics were non-calcified, non-tortuous, and had 0% stenosis.The device was never placed in an acute bend during its use in the patient, and there was no difficulty removing the device from the patient.A non-sterile 5f tempo 0.038" 125cm vert135 catheter unit was received coiled inside a transparent plastic bag.Upon unpacking and visual inspection, a crack was noted on the catheter body approximately 73.4 cm from the distal tip, with no other visible anomalies.Dimensional analysis of the body near the damaged area showed inner and outer diameter measurements within specification for the applicable catalog.Sem analysis of the cracked region revealed micro-elongations consistent with localized stretching due to tensile forces, indicating the material was stressed beyond its elastic limit likely, contributing to the observed crack.No voids, inclusions, or signs of thermal damage were detected.A product history record (phr) review of lot 18161245 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 ¿catheter body/shaft-puncture/cut¿ was not seen during the product evaluation.However, the malfunction ¿catheter body/shaft-/cracked¿ was seen.Product evaluation results suggest the device experienced stress beyond its elastic limit, likely contributing to the crack.Therefore, it is assumed mechanical tension played a key role in the damages.The exact source of this tension is unknown.Procedural/handling factors are a possible cause of the reported event.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, ¿store in a cool, dark, dry place.Do not use if package is open or damaged.¿ based on the information available and the phr review, there is no evidence to suggest the event is related to the device design or manufacturing process.Therefore, no preventative or corrective actions will be taken at this time.
Event or Problem Description
As reported, there were multiple holes throughout the length of a 5f 125cm 135-degree vertebral (vert) tempo diagnostic catheter.The damage to the catheter was observed during a cerebral angiogram, and the catheter was in the right m2 vessel when the damage was observed.There were no reported injuries to the patient.The device was stored and prepped per the instructions for use (ifu) and there was no damage to the device packaging.The vessel characteristics were non-calcified, non-tortuous, and had 0% stenosis.The device was never placed in an acute bend during its use in the patient, and there was no difficulty removing the device from the patient.The device has now been returned.Addendum: product evaluation revealed a crack on the body/shaft of the catheter.

• Brand Name: TEMPO
• Common Device Name: CATHETER, INTRAVASCULAR, DIAGNOSTIC
• Manufacturer (Section D): CORDIS US. CORP; 14201 nw 60 avenue; miami lakes FL 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: 21720353
• Report Number: 9616099-2025-00503
• Device Sequence Number: 13146016
• Product Code: DQO
• UDI-Device Identifier: 10705032051774
• UDI-Public: (01)10705032051774(17)251031(10)18161245
• 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: Health Professional,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup,Followup,Followup
• Report Date (Section B): 07/29/2025

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
• Device Expiration Date: 10/31/2025
• Device Catalogue Number: SRD6892
• Device Lot Number: 18161245
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/04/2025
• Supplement Date Received by Manufacturer: 04/10/2025; 05/05/2025; 06/02/2025; 07/23/2025
• Initial Report FDA Received Date: 03/28/2025
• Supplement Report FDA Received Date: 05/05/2025; 05/09/2025; 06/27/2025; 07/29/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/04/2022
• 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 Age: 29 YR
• Patient Sex: Male