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

Model Number 401611M

Device Problem Crack (1135)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 08/03/2021

Event Type  malfunction  

Manufacturer Narrative

This device is not available for testing and evaluation.A review of the manufacturing documentation associated with this lot# 18024811 presented no issues during the manufacturing process that can be related to the reported complaint.Additional information is pending and will be submitted within 30 days upon receipt.

Event Description

As reported a si brite tip 6f 11cm str was used for an endovascular therapy case.The device was noted to be ¿turned up¿ and a crack was confirmed at the distal end of the device.The device could not be used for the procedure.There was no patient injury.The device will not be returned.

Manufacturer Narrative

After further reviewed of additional information received the following sections have been updated accordingly :g3, g4, g6, h1, h2, h3 and h6.As reported a si brite tip 6f 11cm str was used for an endovascular therapy case.The device was noted to be ¿turned up¿ and a crack was confirmed at the distal end of the device.The device could not be used for the procedure.There was no reported patient injury.The device was not returned for analysis.A product history record (phr) review of lot 18024811 revealed no anomalies or non-conformances during the manufacturing and inspection processes that can be associated with the reported event.The reported ¿brite tip/distal tip-cracked - during prep¿ could not be confirmed as the device was not returned for analysis.The exact cause of the event could not be determined.Procedural factors, such as operator handling during prep, could have contributed to the event.According to the instructions for use (ifu) which is not intended as a mitigation of risk, ¿do not use if package is open or damaged.¿ users are clinically trained to inspect devices prior to use and during prep and immediate discontinue and change the device if any damage is noted.Neither the phr, nor the information available, suggests a design or manufacturing related cause for the reported event; therefore, no corrective/preventive action will be taken at this time.

• Brand Name: SI BRITE TIP 6F 11CM STR
• Type of Device: INTRODUCER, CATHETER
• Manufacturer (Section D): CORDIS CORPORATION; 14201 nw 60 avenue; miami lakes FL 33014
• MDR Report Key: 12536738
• MDR Text Key: 274533573
• Report Number: 9616099-2021-04900
• Device Sequence Number: 1
• Product Code: DYB
• Combination Product (y/n): N
• PMA/PMN Number: K984500
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 10/05/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/27/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 401611M
• Device Catalogue Number: 401611M
• Device Lot Number: 18024811
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 09/30/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1