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

Catalog Number	534520T
Medical Device Problem Code	Degraded (1153)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/19/2024
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, six (6) unopened 5f 100cm judkins left (jl) 4 infiniti diagnostic catheters, one (1) unopened 5f 100cm judkins left (jl) 3.5 infiniti diagnostic catheter, and one (1) unopened 5f 100cm judkins right (jr) 4 infiniti diagnostic catheter were found to be coming apart within their packaging.The devices appear to be ¿dry rotting¿, and the blue polytetrafluoroethylene (ptfe) coating is flaking off inside of their packaging.The flaking appears to be coming from where the hub is attached to the catheter collar on each device.The issue was found during a review of inventory and the devices were not selected for a procedure or opened for use.The devices were stored in a pyxis machine and were not exposed to ultraviolet (uv) light.There were no damages to the packaging for these devices and the devices are still within their sterile packaging.It was confirmed that the devices are not expired.The devices will be returned 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, h10, and h11.This device has been analyzed but the final, approved draft of the engineering report and its conclusion is not yet available.However, it 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: b4, g3, g6, h1, h2, h3, h6, and h11.Complaint conclusion: as reported, six (6) unopened 5f 100cm judkins left (jl) 4 infiniti diagnostic catheters, one (1) unopened 5f 100cm judkins left (jl) 3.5 infiniti diagnostic catheter, and one (1) unopened 5f 100cm judkins right (jr) 4 infiniti diagnostic catheter were found to be coming apart within their packaging.The devices appear to be ¿dry rotting¿, and the blue polytetrafluoroethylene (ptfe) coating is flaking off inside of their packaging.The flaking appears to be coming from where the hub is attached to the catheter collar on each device.The issue was found during a review of inventory and the devices were not selected for a procedure or opened for use.The devices were stored in a pyxis machine and were not exposed to ultraviolet (uv) light.There was no damage to the packaging for these devices and the devices are still within their sterile packaging.It was confirmed that the devices are not expired.The issue involved visible degradation of strain relief material and the presence of large loose particulates inside the product pouch.The 8 affected devices, unboxed but still in the sterile barrier, were received for analysis.The samples correspond to the following catalog/lot numbers: 534-520t (lot #18190247, 18164218), 534-521t (lot #18218926), and 534-518t (lot #18093338).Each sample was inspected individually prior to opening the sterile barrier.The inspection confirmed the degradation of the strain relief material in all samples, showing partial to complete disintegration.Loose particulates found within the pouch were consistent with debris from the degraded strain relief.Importantly, all affected units were within labeled shelf life.To contextualize the findings, the team compared the affected units against real time aging (rta) retain samples from the same infiniti product family; those rta controls exhibited no degradation, damage, or packaging anomalies.A subsequent supply chain query verified that the affected lots underwent standard sterilization and routine transport prior to distribution.Investigative testing replicated degradation by exposing strain relief components to a uv-c sanitizing lamp, commonly used in hospital setting, resulting in visible degradation within 36 hours.The findings suggest a likely association between off-label environmental exposure (such as extreme heat or uv light) and the observed material failure.The reported ¿strain relief ¿ degradation¿ was observed during product analysis, with visual disintegration and flaking identified across all returned devices.The devices were within expiration and remained in sterile packaging.While the exact root cause could not be conclusively determined from inspection alone, the replication testing strongly supports environmental exposure, specifically uv-c light as a contributing factor.Potential contributors also include elevated temperatures, such as from improper storage in vehicles, or sunlight exposure.According to the instructions for use (ifu), devices must be ¿stored in a cool, dark, dry place¿ and should not be exposed to temperatures exceeding 54ºc (130ºf).While the customer indicated that the pyxis storage location excluded uv exposure, the test data indicates these materials are susceptible under real-world sanitizing conditions.Based on the available information and product analysis, the exact cause of the strain relief degradation could not be determined; however, it is potentially related to the manufacturing process of the unit.Therefore, a risk assessment has been initiated to further review the potential causes.No further action will be taken at this time.

• Brand Name: INFINITI
• 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: 20912944
• Report Number: 9616099-2024-00506
• Device Sequence Number: 8476202
• Product Code: DQO
• UDI-Device Identifier: 10705032013680
• UDI-Public: (01)10705032013680(17)260228(10)18190247
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K970854
• 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
• Report Date (Section B): 05/16/2025

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: 02/28/2026
• Device Catalogue Number: 534520T
• Device Lot Number: 18190247
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/26/2024
• 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: 11/19/2024
• Supplement Date Received by Manufacturer: 03/14/2025; 05/14/2025
• Initial Report FDA Received Date: 12/12/2024
• Supplement Report FDA Received Date: 04/08/2025; 05/16/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/06/2023
• 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 Sex: Unknown