MAUDE Adverse Event Report: CORDIS CORPORATION SI BRITE TIP 7F 23CM STR; INTRODUCER, CATHETER

Model Number	401723M
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	09/24/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device has been returned for evaluation, but the manufacture report is not yet available.A review of the device history record (dhr) associated with lot 17908009 revealed no anomalies during the manufacturing and inspection processes that can be associated with the reported event.Additional information is pending and will be sent in upon 30 days after receipt.
Event or Problem Description
As reported, the valve of the two (2) 7f 23cm brite tip catheter sheath introducer (csi) leaked a lot and the cap coming off the sheath just by taking out the unknown wire from the sheath.The physician was able to take out the leaking sheath and replace it with a new unknown sheath.There was no reported patient injury.The operator was trained to the brite tip sheath.The devices were opened in sterile filed.Only one device will be returned for analysis.
Event or Problem Description
As reported, the valve of the two (2) 7f 23cm brite tip catheter sheath introducers (csi) were leaking and the cap came off the sheath when the user took out the unknown wire from the sheath.The physician was able to take out the leaking sheath and replace it with a new unknown sheath.There was no reported patient injury.The operator was trained to the brite tip sheath.The devices were opened in sterile field.The devices were stored, handled, and prepped per the instructions for use (ifu).There was no difficulty experienced in prepping the devices.There were no anomalies noted prior to inserting into the patient.There was no damage noticed to the devices prior to opening the package.There was no difficulty removing the devices from the sterile packaging.The device was not pulled from the packaging by the hub.There were no reported patient injuries.Only one device will be returned for analysis.
Additional Manufacturer Narrative
As reported, the valve of the two (2) 7f 23cm brite tip catheter sheath introducers (csi) were leaking and the cap came off the sheath when the user took out the unknown wire from the sheath.The physician was able to take out the leaking sheath and replace it with a new unknown sheath.There was no reported patient injury.The operator was trained to the brite tip sheath.The devices were opened in sterile field.The devices were stored, handled, and prepped per the instructions for use (ifu).There was no difficulty experienced in prepping the devices.There were no anomalies noted prior to inserting into the patient.There was no damage noticed to the devices prior to opening the package.There was no difficulty removing the devices from the sterile packaging.The device was not pulled from the packaging by the hub.There were no reported patient injuries.One non-sterile unit of catheter si brite tip 7f 23cm str was received inside of a clear plastic bag.The device was unpacked to proceed with the product evaluation.Per visual analysis, the cannula, and the vessel dilator were returned for analysis.No damages or anomalies were observed at naked eye on the components returned.Per functional analysis, a flushing test was performed.No difficulty was noted during the test.No leakage was observed trough the cannula, the hub, or the hemostasis valve.Amplified images of the hub and the hemostasis valve were taken to observe a possible damage, but only blood residues were found.No other anomalies were observed.A product history record (phr) review of lot 17908009 revealed no anomalies or non-conformances during the manufacturing and inspection processes that can be associated with the reported event.The reported ¿hemostasis valve/hub ¿ separated - during use¿ and ¿ hemostasis valve/hub - leakage - during use¿ was not confirmed in the returned device as no damages were observed and during functional flushing test no leakage was noted.The exact cause of the reported event could not be conclusively determined.Based on the information reported and the analysis of the returned device, it is impossible to determine what may have contributed to the reported events.According to the instructions for use which is not intended as a mitigation of risk ¿remove air from csi (including side port extension) by inverting and flushing with heparinized saline or suitable isotonic solution¿.The ifu also warns users to discard the device if there are damages noted during inspection.Neither the phr review nor the product analysis suggests that the reported failure could be related to the manufacturing process of the unit.No corrective or preventive actions will be taken.This is one of two devices involved in the reported event.The reporting reference number of the related device is 9616099-2020-04002.

• Brand Name: SI BRITE TIP 7F 23CM STR
• Common Device Name: INTRODUCER, CATHETER
• Manufacturer (Section D): CORDIS CORPORATION; 14201 nw 60th ave; miami lakes FL 33014
• MDR Report Key: 10712639
• Report Number: 9616099-2020-04001
• Device Sequence Number: 3933008
• Product Code: DYB
• UDI-Device Identifier: 20705032000311
• UDI-Public: 20705032000311
• Combination Product (Y/N): N
• Initial Reporter State: GA
• Initial Reporter Country: US
• PMA/510(K) Number: K984500
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 11/09/2020

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: 10/31/2022
• Device Model Number: 401723M
• Device Catalogue Number: 401723M
• Device Lot Number: 17908009
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/30/2020
• Initial Date Received by Manufacturer: 09/25/2020
• Supplement Date Received by Manufacturer: 10/26/2020
• Initial Report FDA Received Date: 10/21/2020
• Supplement Report FDA Received Date: 11/09/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: UNK SHEATH; UNK WIRE