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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 10/31/2020
Event Type  Malfunction  
Manufacturer Narrative

One hemostasis valve introducer with a dilator inserted was returned for examination. The reported event of dilator blocked was confirmed. A lab 0. 035" guidewire was inserted from tip to hub and from hub to tip. The guidewire stopped at 0. 5cm approximately from the tip. A cutdown of the dilator found a blockage caused by an unknown light blue material. No visual inconsistencies were noticed from the returned unit. Chemistry analysis found that the sample spectrum is consistent with polyethylene. An investigation is underway to see if the substance found is used in the manufacturing process. A review of the manufacturing records indicated that the product met specifications upon release. 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, no patient complications were noted. 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.

 
Event Description

It was reported that during use in a patient of this introducer, the dilator of the sheath tube was "blocked"; therefore, the guide wire could not go through. The problem was solved by replacing the sheath tube. There was no allegation of patient injury. The device was available for evaluation. Patient demographics were unable to be obtained.

 
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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
Manufacturer (Section G)
EDWARDS LIFESCIENCES PR
state rd indus pk 402 km 1.4
anasco PR
Manufacturer Contact
jessica atallah
1 edwards way
irvine, CA 92614
9492500294
MDR Report Key10968745
MDR Text Key220980073
Report Number2015691-2020-14920
Device Sequence Number1
Product Code DQY
Combination Product (Y/N)N
Reporter Country CodeCH
PMA/PMN NumberK831729
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 10/31/2020
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received12/08/2020
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device EXPIRATION Date08/27/2021
Device MODEL NumberI300F85
Device LOT Number62526563
Was Device Available For Evaluation? Device Returned To Manufacturer
Date Returned to Manufacturer11/18/2020
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received12/14/2020
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Date Device Manufactured09/04/2019
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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