MAUDE Adverse Event Report: CORDIS US CORP. BRITE TIP; INTRODUCER, CATHETER

Catalog Number	401611M
Medical Device Problem Codes	Material Frayed (1262); Material Split, Cut or Torn (4008)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/26/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Complaint conclusion: as reported, a 6f 11cm brite tip sheath introducer had a significant defect at the tip of the sheath.There were no reports of patient injury.Multiple attempts to obtain supplemental information were made; however, additional event details were not provided.A catheter sheath was received for evaluation in a non-sterile condition, enclosed in a clear plastic bag.Only the sheath was returned, and visual inspection showed a torn distal tip with no other visible damage.Microscopic examination revealed multiple surface scratches, micro-elongations in the plastic, discoloration along the edges, and plastic deformation.These characteristics are consistent with mechanical stress, likely caused by sharp objects or tensile forces.The presence of edge discoloration may suggest material fatigue resulting from external forces.No manufacturing or assembly defects were identified.The failure does not appear to be related to the manufacturing process.The reported customer event ¿brite tip/distal tip-frayed/split/torn¿ could not be confirmed.The exact cause of the damages is unknown however, exposure to a sharp medical instrument may have contributed to 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, ¿do not scratch the sheath with needle point, cutting tool, or other edged tools.Do not introduce sharp medical instruments which can lead to device damage.¿ based on the available information and product analysis, 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, a 6f 11cm brite tip sheath introducer had a significant defect at the tip of the sheath.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.Addendum: per pe findings, the sheath was received with the distal tip torn.

• Brand Name: BRITE TIP
• Common Device Name: INTRODUCER, CATHETER
• Manufacturer (Section D): CORDIS US CORP.; 14201 nw 60 avenue; miami lakes
• Manufacturer (Section G): CORDIS US CORP.; 14201 nw 60 avenue; miami lakes FL 33014
• Manufacturer Contact: karla castro ; santiago troncoso 808; juarez, chihuahua 32574 ; MX 32574 ; 7863138372
• MDR Report Key: 22378103
• Report Number: 9616099-2025-01046
• Device Sequence Number: 11865510
• Product Code: DYB
• UDI-Device Identifier: 10705032000239
• UDI-Public: (01)10705032000239(17)271130(10)18400433
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: K984500
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 07/01/2025

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: 401611M
• Device Lot Number: 18400433
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/19/2025
• 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: 06/14/2025
• Initial Report FDA Received Date: 07/01/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/14/2024
• 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: UNKNOWN.
• Patient Sex: Unknown