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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: CORDIS CORPORATION 6F10CM SW RADIAL; INTRODUCER, CATHETER

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CORDIS CORPORATION 6F10CM SW RADIAL; INTRODUCER, CATHETER Back to Search Results
Model Number 506610S
Device Problem Peeled/Delaminated (1454)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 12/01/2020
Event Type  malfunction  
Manufacturer Narrative
A review of the manufacturing documentation associated with this lot presented no issues during the manufacturing process that can be related to the reported complaint.This device is available for analysis but the engineering report is not yet available.However, it will be submitted within 30 days upon receipt.Additional information is pending and will be submitted within 30 days upon receipt.
 
Event Description
When a 6f 10cm sw transradial rain sheath introducer was pushed in, the hydrophilic coating was pushed together.Therefore, the sheath has been removed and continued with the non-cordis sheath.There was no reported patient injury.The user is still in training with the device.The device was opened in a sterile field.The sheath was well watered just before insertion.The device will be returned for evaluation.
 
Manufacturer Narrative
Complaint conclusion: when a 6f 10cm sw transradial rain sheath introducer was pushed in, the hydrophilic coating was pushed together.Therefore, the sheath had been removed and continued with a non-cordis sheath.There was no reported patient injury.The user is still in training with the device.The device was opened in a sterile field.The sheath was well watered just before insertion.The product was returned for analysis.A non-sterile unit of ¿6f10cm sw radial¿ was received inside of a clear plastic bag.Per visual analysis, the vessel dilator was returned already inserted inside the csi cannula.The part was thoroughly inspected observing an accordioned condition located approximately at 1.8 cm from the distal tip.No delamination condition was observed.No other damages or anomalies were observed on the returned unit.Dimensional analysis results for the cannula were found within specification.The cannula was inspected using a vision system to obtain a magnified image.The accordioned condition was confirmed, and no delamination characteristics were observed.A product history record (phr) review of lot 17972089 revealed no anomalies or non-conformances during the manufacturing and inspection processes that can be associated with the reported event.The reported ¿coating-sheaths delaminated¿ was not confirmed during analysis of he returned device.No delamination condition was observed.However, the cannula presented with an accordioned condition.The exact cause of the reported events could not be conclusively determined.Procedural factors, such as excessive force used, may have contributed to the reported events.According to the instructions for use, which is not intended as a mitigation of risk, ¿do not use if package is open or damaged.¿ neither the phr review nor the product analysis suggests that the reported events could be related to the manufacturing process of the unit.Therefore, no corrective or preventive actions will be taken at this time.
 
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Brand Name
6F10CM SW RADIAL
Type of Device
INTRODUCER, CATHETER
Manufacturer (Section D)
CORDIS CORPORATION
14201 nw 60 avenue
miami lakes FL 33014
MDR Report Key11099847
MDR Text Key224521195
Report Number9616099-2020-04165
Device Sequence Number1
Product Code DYB
Combination Product (y/n)N
PMA/PMN Number
K984500
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,health
Type of Report Initial,Followup
Report Date 01/20/2021
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
Device Operator Health Professional
Device Expiration Date08/31/2023
Device Model Number506610S
Device Catalogue Number506610S
Device Lot Number17972089
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer12/21/2020
Initial Date Manufacturer Received 12/07/2020
Initial Date FDA Received12/31/2020
Supplement Dates Manufacturer Received01/13/2021
Supplement Dates FDA Received01/20/2021
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Treatment
MERRIT SHEATH; MERRIT SHEATH
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