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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: CORDIS CORPORATION UNKNOWN TRANSRADIAL SHEATH INTRODUCER, CATHETER

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CORDIS CORPORATION UNKNOWN TRANSRADIAL SHEATH INTRODUCER, CATHETER Back to Search Results
Catalog Number UNKTRANSRADIALSHEATH
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Obstruction/Occlusion (2422); Pseudoaneurysm (2605)
Event Date 05/31/2022
Event Type  Injury  
Manufacturer Narrative
The actual event date is unknown, as the event was captured from a survey. As reported, the respondent indicated a occlusion and pseudoaneurysm occurred from a unknown transradial sheath, which was related to a pms survey. The products were not returned for analysis and 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 events ¿vascular occlusion and vascular pseudoaneurysm¿ could not be confirmed. The exact cause of the reported events cannot be conclusively determined with the limited information provided. These are known complications and are listed in the ifu as such. Users are trained to inspect for signs of damage prior to and during use. Any product with damage is not to be used. Information for safety is provided in the products labeling with the intent to make the user aware of the risks. According to the instructions for use (ifu), although not intended as a mitigation of risk, ¿possible complications include, but are not limited to: abrupt vessel closure, additional intervention, allergic reaction (device, contrast medium and medications), air embolism, infection, intimal tear, hematoma at puncture, hemorrhage, inflammation / infection / sepsis, ischemia, perforation of vessel wall, thrombus formation, peripheral nerve injury, pain, vascular complications (e. G. Intimal tear, dissection, pseudo aneurysm, perforation, rupture, spasm, occlusion). To prevent damage to the csi tip or kinking of the csi body, do not withdraw the vessel dilator while advancing and positioning the csi in the vessel. ¿ 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.
 
Event Description
As reported, the respondent indicated a occlusion and pseudoaneurysm occurred from a unknown transradial sheath which was related to a pms survey. The device will not be returned for evaluation.
 
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Brand NameUNKNOWN TRANSRADIAL SHEATH
Type of DeviceINTRODUCER, CATHETER
Manufacturer (Section D)
CORDIS CORPORATION
14201 nw 60 avenue
miami lakes FL 33014
Manufacturer (Section G)
CARDINAL HEALTH MEXICO 244 S DE RL DE CV
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 Key14783067
MDR Text Key295048274
Report Number9616099-2022-05733
Device Sequence Number1
Product Code DYB
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K181592
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Foreign,Health Professional,Company Representative
Reporter Occupation Other Health Care Professional
Type of Report Initial
Report Date 06/22/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received06/22/2022
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Catalogue NumberUNKTRANSRADIALSHEATH
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Date Manufacturer Received05/31/2022
Was Device Evaluated by Manufacturer? No Answer Provided
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

Patient Treatment Data
Date Received: 06/22/2022 Patient Sequence Number: 1
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