MAUDE Adverse Event Report: CORDIS CORPORATION SI 9F BRITE TIP SHEATH 11CM; INTRODUCER, CATHETER

Model Number	401911M
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	08/19/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The tip of the 9f 11cm brite tip catheter sheath introducer (csi) became detached during procedure.The sheath was inserted in the patient and was seen during the angiogram that the tip had detached about an inch away from the sheath itself, being held by the wire.The entire sheath/tip was retrieved.The product was not returned for analysis.A product history record (phr) review of lot 17921875 revealed no anomalies or non-conformance's during the manufacturing and inspection processes that can be associated with the reported event.The reported ¿brite tip/distal tip separated - 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.Based on the information available for review it is impossible to determine what factors may have contributed to the reported event.According to the product instructions for use, which is not intended as a mitigation of risk, users are cautioned that if increased resistance is felt upon insertion or withdrawal 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.Neither the phr nor the information available for review suggests that the reported event could be related to the manufacturing process of the unit.Therefore, no corrective or preventative actions will be taken at this time.
Event or Problem Description
The tip of the 9f 11cm brite tip catheter sheath introducer (csi) became detached during procedure.The sheath was inserted in the patient and was seen during the angiogram that the tip had detached about an inch away from the sheath itself, being held by the wire.The entire sheath/tip was retrieved.The device will not be returned for analysis.

• Brand Name: SI 9F BRITE TIP SHEATH 11CM
• Common Device Name: INTRODUCER, CATHETER
• Manufacturer (Section D): CORDIS CORPORATION; 14201 nw 60th ave; miami lakes FL 33014
• MDR Report Key: 10553113
• Report Number: 9616099-2020-03913
• Device Sequence Number: 11498132
• Product Code: DYB
• UDI-Device Identifier: 10705032000437
• UDI-Public: 10705032000437
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: K984500
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 09/18/2020

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: 12/31/2022
• Device Model Number: 401911M
• Device Catalogue Number: 401911M
• Device Lot Number: 17921875
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/21/2020
• Initial Report FDA Received Date: 09/18/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1