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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: EDWARDS LIFESCIENCES, PR PERCUTANEOUS SHEATH INTRODUCER SET CATHETER, PERCUTANEOUS

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EDWARDS LIFESCIENCES, PR PERCUTANEOUS SHEATH INTRODUCER SET CATHETER, PERCUTANEOUS Back to Search Results
Model Number I300F85
Device Problem Device Contamination with Chemical or Other Material (2944)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 09/14/2018
Event Type  malfunction  
Manufacturer Narrative
Our product evaluation laboratory received two images for review. Both images showed the identical sample of a hemostasis introducer with a dilator inserted in the valve housing. An unknown, brownish material was taped to the introducer. The composition of the unknown substance was not able to be determined from the image. A device history record review was completed and documented that the device met all specifications upon distribution. The customer report of "foreign matter" was confirmed on evaluation. An engineering evaluation has been initiated to assess for any manufacturing-related processes which could be correlated to the complaint. With an indwelling introducer, it is common for the clinician to check for air or particulates while priming the line for use. Additionally, these products are used by highly trained clinicians, experienced in identifying and mitigating any hazards that arise. Invasive procedures involve some patient risks. Although serious complications are relatively uncommon, the physician is advised to consider the potential benefits in relation to the possible complications. In this event, this issue was noted before use and the device was not used with a patient. Complaint histories for all reported events are reviewed against trending control limits on a monthly basis, and any excursions above the control limits are assessed and documented as part of this monthly review. (b)(4).
 
Event Description
It was reported that prior to use of an introflex introducer, foreign matter was noticed inside lumen. There was no patient injury. The device was discarded, but images were provided.
 
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Brand NamePERCUTANEOUS SHEATH INTRODUCER SET
Type of DeviceCATHETER, PERCUTANEOUS
Manufacturer (Section D)
EDWARDS LIFESCIENCES, PR
state rd indus pk 402 km 1.4
anasco PR 00610
Manufacturer (Section G)
EDWARDS LIFESCIENCES, PR
state rd indus pk 402 km 1.4
anasco PR 00610
Manufacturer Contact
samantha eveleigh
one edwards way
irvine, CA 92614
9492503939
MDR Report Key7926717
MDR Text Key122635880
Report Number2015691-2018-04003
Device Sequence Number1
Product Code DQY
Combination Product (y/n)N
Reporter Country CodeCH
PMA/PMN Number
K831729
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Reporter Occupation Other Health Care Professional
Type of Report Initial,Followup
Report Date 09/14/2018
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received10/02/2018
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date04/29/2020
Device Model NumberI300F85
Device Lot Number61371713
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received07/23/2020
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured05/04/2018
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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