MAUDE Adverse Event Report: CORDIS CORPORATION SI BRITE TIP 7F 11CM STR; INTRODUCER, CATHETER

Model Number	401711M
Medical Device Problem Code	Material Frayed (1262)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	10/02/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
As reported, a 7f 11cm straight (str) brite tip sheath introducer was inserted; but the distal end got frayed.Therefore, it was not used for the procedure.There was no reported patient injury.The device was stored and handled per the instruction for use (ifu).There were no visible signs of device/package damage prior to use.The integrity of the sterile pouch was not compromised.The device was prepped according to instructions for use (ifu).There were no anomalies noted during or after the device was prepped.There were no kinks or other damages noted prior to inserting the product into the patient.There was no unusual force used at any time during the procedure.There was no patient injury.The product was not returned for analysis.A product history record (phr) review of lot 17848066 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 frayed/split/torn - in patient¿ could not be confirmed as the device was not returned for analysis.The exact cause of the reported event could not be conclusively determined.Handling factors may have contributed to the reported event.According to the product instructions for use, users are cautioned to inspect the device before use to verify that its size and condition are suitable for the specific procedure.Based on the device history record review, there is no indication that the event is related to the device manufacturing process.Therefore, no corrective or preventative actions will be taken at this time.
Event or Problem Description
As reported, a 7f 11cm straight (str) brite tip sheath introducer was inserted; but the distal end got frayed.Therefore, it was not used for the procedure.There was no reported patient injury.The device was stored and handled per the instruction for use (ifu).There were no visible signs of device/package damage prior to use.The integrity of the sterile pouch was not compromised.The device was prepped according to instructions for use (ifu).There were no anomalies noted during or after the device was prepped.There were no kinks or other damages noted prior to inserting the product into the patient.There was no unusual force used at any time during the procedure.There was no patient injury.The device will not be returned for evaluation as it was discarded in the hospital.

• Brand Name: SI BRITE TIP 7F 11CM STR
• Common Device Name: INTRODUCER, CATHETER
• Manufacturer (Section D): CORDIS CORPORATION; 14201 nw 60th ave; miami lakes FL 33014
• MDR Report Key: 10697793
• Report Number: 9616099-2020-03991
• Device Sequence Number: 3174481
• Product Code: DYB
• UDI-Device Identifier: 20705032000304
• UDI-Public: 20705032000304
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K984500
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 10/19/2020

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: 02/28/2022
• Device Model Number: 401711M
• Device Catalogue Number: 401711M
• Device Lot Number: 17848066
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/02/2020
• Initial Report FDA Received Date: 10/19/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1