MAUDE Adverse Event Report: CORDIS CORPORATION SI BRITE TIP 6F 11CM STR; INTRODUCER, CATHETER

Model Number	401611M
Medical Device Problem Code	Material Split, Cut or Torn (4008)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/20/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A review of the manufacturing documentation associated with lot 18097707 presented no issues during the manufacturing process that can be related to the reported event.Complaint conclusion: as reported, while using a 6f straight brite tip catheter sheath introducer, a puncture was made, and insertion difficulty was encountered due to a gap between the dilator and sheath.The physician tried many times, then the distal tip got frayed making insertion.The procedure was completed with another unknown device.There was no reported patient injury.The target lesion was the right inguinal region.The device was stored, handled, and prepped as per instructions for use (ifu).The device was inspected prior to use for damages and there were no damages noted.There was no damage noted to the packaging of the device.The access vessel was severely calcified.There was mild vessel tortuosity and there was 80 percent stenosis.The device was not used for a chronic total occlusion (total occlusion >3 months).The product was not returned for analysis.A product history record (phr) review of lot 18097707 revealed no anomalies or non-conformances during the manufacturing and inspection processes that can be associated with the reported event.Without the return of the device or images for analysis, the reported customer event ¿vessel dilator- incompatibility/fit - with sheath¿ and ¿brite tip/distal tip- frayed/split/torn¿ could not be confirmed.Handling factors 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 to make the user aware of the risks.According to the instructions for use (ifu), although not intended as a mitigation of risk, ¿if increased resistance is felt upon insertion of the csi, investigate the cause before continuing.If the cause of the resistance cannot be determined and corrected, discontinue the procedure, and withdraw the csi.Insert the vessel dilator through the csi¿s hemostasis valve, snapping it into place at the hub¿ 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.
Event or Problem Description
As reported, a puncture was made and a 6f straight brite tip catheter sheath introducer (csi) was attempted to be inserted but insertion was difficult due to a gap between a dilator and the sheath.The physician tried many times repeatedly and the distal tip got frayed and insertion was impossible.The procedure was completed with another unknown device.There was no reported patient injury.The target lesion was the right inguinal region.The device was stored, handled, and prepped as per instructions for use (ifu).The device was inspected prior to use for damages and there were no damages noted.There was no damage noted to the packaging of the device.The access vessel was severely calcified.There was mild vessel tortuosity and there was 80 percent of stenosis.The device was not used for a chronic total occlusion (total occlusion >3 months).The device was discarded and will not be returned for evaluation.

• Brand Name: SI BRITE TIP 6F 11CM STR
• 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: 15457751
• Report Number: 9616099-2022-05999
• Device Sequence Number: 15167438
• Product Code: DYB
• UDI-Device Identifier: 10705032000239
• UDI-Public: (01)10705032000239(17)250228(10)18097707
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• 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): 09/20/2022

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: 02/28/2025
• Device Model Number: 401611M
• Device Catalogue Number: 401611M
• Device Lot Number: 18097707
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/02/2022
• Initial Report FDA Received Date: 09/20/2022
• Date Device Manufactured: 03/29/2022
• 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: ANOTHER UNKNOWN DEVICE
• Patient Age: 80
• Patient Sex: Female
• Patient Weight: 42 KG