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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: EDWARDS LIFESCIENCES, PR SWAN-GANZ DOUBLE LUMEN MONITORING CATHETER; CATHETER, INTRAVASCULAR, DIAGNOSTIC

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EDWARDS LIFESCIENCES, PR SWAN-GANZ DOUBLE LUMEN MONITORING CATHETER; CATHETER, INTRAVASCULAR, DIAGNOSTIC Back to Search Results
Model Number 110F5
Device Problem Material Puncture/Hole (1504)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 03/09/2022
Event Type  malfunction  
Event Description
It was reported that, the packaging on these 2 swan-ganz catheters from the same lot number were observed to have puncture-like holes and what looks like condensation marks.Images were provided by the customer.There was no patient injury reported.The customer shared that there were multiple devices that had the same issue.As a result of the issue found, the customer pulled their model 123f6p and 110f5 swan-ganz catheters and inspected them all for holes in the packaging.The issue was resolved by switching to a non-edwards brand pulmonary artery catheter.
 
Manufacturer Narrative
The device evaluations are anticipated.However, the complaint cannot not be confirmed without the completion of a product evaluation.A supplemental report will be forthcoming with the evaluation results when received.A device history record review was completed and documented that device met all specifications upon distribution.Devices not returned.
 
Manufacturer Narrative
The product is no longer available, as it was lost in transportation per the shipping company.Should the product be found and returned, the complaint will be reopened and a supplemental of the evaluation results will be sent.The complaint will be closed as no product return.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 a part of the monthly review.
 
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Brand Name
SWAN-GANZ DOUBLE LUMEN MONITORING CATHETER
Type of Device
CATHETER, INTRAVASCULAR, DIAGNOSTIC
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
jessica atallah
1 edwards way
irvine, CA 92614
9492500294
MDR Report Key14015239
MDR Text Key297600946
Report Number2015691-2022-04838
Device Sequence Number1
Product Code DQO
UDI-Device Identifier50690103000264
UDI-Public(01)50690103000264(17)230811(11)210811(10)63916772
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
PREAMENDMEN
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Health Professional,User Facility
Reporter Occupation Other Health Care Professional
Type of Report Initial,Followup
Report Date 05/06/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received04/05/2022
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Expiration Date08/11/2023
Device Model Number110F5
Device Lot Number63916772
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? No
Date Manufacturer Received05/02/2022
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured08/11/2021
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
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