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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: CORDIS CORPORATION RAILWAY ACCESS KIT, 6F, VBT, SS WIRE INTRODUCER, CATHETER

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CORDIS CORPORATION RAILWAY ACCESS KIT, 6F, VBT, SS WIRE INTRODUCER, CATHETER Back to Search Results
Catalog Number RW6VBTB
Device Problems Partial Blockage (1065); Device Contamination with Chemical or Other Material (2944)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 10/18/2021
Event Type  malfunction  
Event Description
As reported, a 6f railway access kit could not pass an unknown standard 035 j wire through. Another railway access kit was used to complete the procedure. No injury was reported to the patient. During product analysis a lengthwise section cut was performed on the obstructed area to analyze the fusion area observing that the problem was caused by a foreign material. The resistance with the wire was met immediately. The product was stored and handled according to the ifu. The product was inspected and prepped according to the instructions for use. The device would not flush out both ends fully. Nothing unusual was noted about the device prior to use. No other devices were used with the product. The device is being returned for evaluation.
 
Manufacturer Narrative
A review of the manufacturing documentation associated with lot 17978589 presented no issues during the manufacturing process that can be related to the reported event. Product analysis is currently undergoing further testing and results will be submitted within 30 days. Additional information is pending and will be submitted within 30 days upon receipt.
 
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Brand NameRAILWAY ACCESS KIT, 6F, VBT, SS WIRE
Type of DeviceINTRODUCER, 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 Key13551548
MDR Text Key293190617
Report Number9616099-2022-05355
Device Sequence Number1
Product Code DYB
UDI-Device Identifier20705032076903
UDI-Public(01)20705032076903(17)220930(10)17978589
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K180081
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Health Professional,Company Representative
Reporter Occupation Other Health Care Professional
Type of Report Initial,Followup
Report Date 03/18/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received02/17/2022
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date09/30/2022
Device Catalogue NumberRW6VBTB
Device Lot Number17978589
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer11/29/2021
Is the Reporter a Health Professional? Yes
Date Manufacturer Received02/22/2022
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured10/12/2020
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: 02/17/2022 Patient Sequence Number: 1
Treatment
UNK .035 J WIRE
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