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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); Vascular Dissection (3160); No Clinical Signs, Symptoms or Conditions (4582)
Event Date 05/31/2022
Event Type  Injury  
Manufacturer Narrative
As per the transradial sheaths survey, the respondent indicated spasm, occlusion, pseudoaneurysm and dissection. 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 ¿vasospasm, vascular occlusion and vascular pseudoaneurysm¿ could not be confirmed. The exact cause cannot be conclusively determined with the limited information provided. However, patient specific anatomy/physiology and/or user technique may have been contributing factors. 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). ¿ 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 per the transradial sheaths survey, the respondent indicated spasm, occlusion, pseudoaneurysm and dissection. The event date is unknown. The product is not available for analysis. Additional event details were not provided.
 
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Brand NameUNKNOWN TRANSRADIAL SHEATH
Type of DeviceINTRODUCER, CATHETER
Manufacturer (Section D)
CORDIS CORPORATION
14201 nw 60th avenue
miami lakes FL 33014 2802
Manufacturer (Section G)
CORDIS CORPORATION
14201 nw 60th avenue
miami lakes FL 33014 2802
Manufacturer Contact
karla castro
14201 nw 60th avenue
miami lakes, FL 33014-2802
7863138372
MDR Report Key14799784
MDR Text Key295041306
Report Number9616099-2022-05737
Device Sequence Number1
Product Code DYB
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Other
Reporter Occupation Non-Healthcare Professional
Type of Report Initial
Report Date 06/23/2022
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received06/24/2022
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
Date Manufacturer Received05/31/2022
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

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