MAUDE Adverse Event Report: CORDIS CORPORATION UNKBRITETIP; INTRODUCER, CATHETER

Model Number UNKBRITETIP

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Thrombosis/Thrombus (4440)

Event Date 01/01/1980

Event Type  Injury  

Event Description

As reported in a unk femoral sheath and accessories survey the respondent indicated thrombosis.The device will not be returned for evaluation.

Manufacturer Narrative

As reported in a unk femoral sheath and accessories survey the respondent indicated thrombosis.A product history record (phr) review could not be performed because the lot number for this product is unknown.Without the return of the device or images for analysis, the reported customer event ¿thrombosis¿ could not be confirmed.Vessel trauma, and/or inadequate anticoagulation may have contributed to the reported event.Thrombosis is a known potential complication and is listed in the ifu as such.According to the instructions for use (ifu), 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.Possible complications include, but are not limited to air embolism, infection, intimal tear, hematoma at the puncture site, perforation of the vessel wall, thrombus formation.Based on the information available 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.

• Brand Name: UNKBRITETIP
• Type of Device: 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: 14764511
• MDR Text Key: 294542081
• Report Number: 9616099-2022-05731
• Device Sequence Number: 1
• Product Code: DYB
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K984500
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 06/21/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/21/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: UNKBRITETIP
• Device Catalogue Number: UNKBRITETIP
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 05/26/2022
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Life Threatening; Other