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

Catalog Number	SRD6109
Medical Device Problem Code	Crack (1135)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/17/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device was received for analysis, but the engineering report is not yet available.Additional information is pending and will be submitted within 30 days upon receipt.
Event or Problem Description
As reported, the head of the 5f 125 cm sidewinder ii tempo aqua catheter was found to be bent and cracked, and rinsing revealed leakage when the operator opened the package for cerebral angiography super selective.There was no reported patient injury.The device was returned for evaluation.
Additional Manufacturer Narrative
As reported, the head of the 5f 125 cm sidewinder ii tempo aqua catheter was found to be bent and cracked, and rinsing revealed leakage when the operator opened the package for cerebral angiography super selective.Another tempo aqua catheter was used to complete the procedure.There was no reported patient injury.The product was stored and handled according to the instructions for use (ifu).No device damage was noticed prior to opening the package, and there was no difficulty removing the device from the sterile packaging.The device was prepped per the ifu, and no difficulty was experienced in prepping the device a non-sterile catheter labeled ¿catheter 5f tempo aqua 125cm hydrophilic coating¿ was received coiled in a clear plastic bag and unpacked for evaluation.Upon inspection, a cracked condition was observed approximately 7 to 8 cm from the distal tip.No additional physical anomalies were noted.Dimensional analysis conducted near the damaged area confirmed that the outer and inner diameters were within acceptable limits.Visual and microscopic assessments verified the presence of cracking, attributed to environmental degradation rather than mechanical stress.Ft-ir spectral analysis revealed broad absorption bands near 3300 cm ¹ and 1700 cm ¹, indicative of hydrolysis and oxidative degradation.These features correspond to chemical changes in polymers exposed to humidity and uv light, resulting in the formation of reactive species that degrade the polymer backbone.No signs of thermal degradation were found.The damage is consistent with prolonged environmental exposure contributing to polymer breakdown.The reported event ¿brite tip/distal tip-cracked¿ was observed during product analysis.The reported event ¿brite tip/distal tip-kinked/bent¿ was not observed during the evaluation.Additionally, the malfunction ¿catheter (body/shaft)-degradation¿ was discovered during the product evaluation.The crack was likely secondary to degradation, which may have been caused by exposure to unfavorable environmental conditions.Information for safety is provided in the product¿s 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¿ and ¿exposure to temperatures above 54ºc (130ºf) may damage the catheter¿.Based on the available information and product analysis, the cause of the "catheter (body/shaft)-degradation" could not be determined; however, it is potentially related to the manufacturing process of the unit.Therefore, an investigation has been initiated to further review the potential causes.No further action will be taken at this time.

• Brand Name: ENDO DIAGNOSTIC CATHETER
• Common Device Name: CATHETER, INTRAVASCULAR, DIAGNOSTIC
• Manufacturer (Section D): CORDIS US CORP; 14201 nw 60th 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: 21547183
• Report Number: 9616099-2025-00358
• Device Sequence Number: 18076326
• Product Code: DQO
• UDI-Device Identifier: 10705032049795
• UDI-Public: (01)10705032049795(17)251031(10)18163127
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K000579
• 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
• Report Date (Section B): 05/23/2025

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 Expiration Date: 10/31/2025
• Device Catalogue Number: SRD6109
• Device Lot Number: 18163127
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/06/2025
• 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: 02/17/2025
• Supplement Date Received by Manufacturer: 05/20/2025
• Initial Report FDA Received Date: 03/07/2025
• Supplement Report FDA Received Date: 05/23/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/14/2022
• 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
• Concomitant Medical Products and Therapy/Usage Dates: UNK.
• Patient Sex: Unknown