MAUDE Adverse Event Report: CORDIS CORPORATION SI BRITE TIP F5 11CM; INTRODUCER, CATHETER

Model Number	401511M
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	08/26/2022
Type of Reportable Event	Malfunction
Event or Problem Description
As reported, the tip of a 5f bite tip catheter sheath introducer (csi) was damaged when opened.Upon reviewing the sheath, there is a "little lip at the distal end by the radiopaque marker." the sheath was not used because it was noticed to be damaged.Another 5f brite tip sheath was obtained and went in fine.There was no report patient injury.The device was stored as per the instructions for use (ifu).The device will be returned for evaluation.Addendum: as per visual analysis during the product evaluation, the cannula sheath introducer was observed frayed/split/torn damaged on the distal tip of the cannula.
Additional Manufacturer Narrative
A review of the manufacturing documentation associated with lot 18111195 presented no issues during the manufacturing process that can be related to the reported event.Complaint conclusion: as reported, the tip of a 5f bite tip catheter sheath introducer (csi) was damaged when opened.Upon review, there was a "little lip at the distal end by the radiopaque marker." the sheath was not used because it was noticed to be damaged.Another 5f brite tip sheath was obtained and went in fine.There was no report patient injury.The device was stored as per the instructions for use (ifu).A non-sterile si brite tip 5f 11cm cannula sheath introducer and a vessel dilator were received for analysis.The vessel dilator was received fully inserted into the cannula.Per visual analysis, no anomalies were observed on the vessel dilator.However, the cannula of the sheath introducer was observed frayed/split/torn on the distal tip.Per microscopic analysis, the unit was thoroughly inspected under the pal vision system, and the frayed/ split/ torn condition on the tip of the cannula was confirmed.Functional analysis (insertion/ withdrawal test) was performed to verify interaction between cannula and vessel dilator.The vessel dilator was passed through the cannula sheath introducer several times.Resistance was not felt, and no other anomalies were noted.Sem analysis presented evidence of a ruptured condition and scratch marks near the ruptured area.Additionally, an elongation and tensile cracks were observed in the rupture of the sheath.A product history record (phr) review of lot 18111195 revealed no anomalies or non-conformances during the manufacturing and inspection processes that can be associated with the reported event.The complaints reported by the customer as ¿brite tip/distal tip-damaged- during prep¿ and ¿brite tip/distal tip-frayed/ split/ torn¿ were confirmed due to the frayed /split /torn condition noted on the distal tip of the cannula.The exact cause of these conditions could not be conclusively determined during the analysis.The scratch marks noted on the ruptured area are commonly caused by an interaction with a sharp object or mechanical damage.The elongations and tensile cracks noted on the ruptured area are commonly associated with separations caused by material tensile overload.Therefore, it is assumed the material was induced to a tensile force that exceeded the yield strength prior to the separation.This may have been while the using a medical instrument such as forceps.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 to make the user aware of the risks.According to the instructions for use (ifu), although not intended as a mitigation of risk, ¿do not use if package is open or damaged.¿ based on the information available and the phr 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.

• Brand Name: SI BRITE TIP F5 11CM
• Common Device Name: INTRODUCER, CATHETER
• Manufacturer (Section D): CORDIS CORPORATION; 14201 nw 60 avenue; miami lakes FL 33014
• Manufacturer (Section G): CORDIS CORPORATION; 14201 nw 60 avenue; miami lakes FL 33014
• Manufacturer Contact: karla castro ; 14201 nw 60 avenue; miami lakes, FL 33014 ; 7863138372
• MDR Report Key: 15629386
• Report Number: 9616099-2022-06060
• Device Sequence Number: 12780650
• Product Code: DYB
• UDI-Device Identifier: 10705032000178
• UDI-Public: (01)10705032000178(17)250430(10)18111195
• Combination Product (Y/N): N
• Initial Reporter State: OH
• Initial Reporter Country: US
• 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: Health Professional,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 10/18/2022

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: 04/30/2025
• Device Model Number: 401511M
• Device Catalogue Number: 401511M
• Device Lot Number: 18111195
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/31/2022
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/05/2022
• Initial Report FDA Received Date: 10/18/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 05/21/2022
• 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: 5F BRITE TIP SHEATH
• Patient Sex: Unknown