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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: COVIDIEN MFG SOLUTIONS S.A. PALINDROME; CATHETER, HEMODIALYSIS, IMPLANTED
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COVIDIEN MFG SOLUTIONS S.A. PALINDROME; CATHETER, HEMODIALYSIS, IMPLANTED Back to Search Results
Model Number 8888541019P
Medical Device Problem Code Break (1069)
Health Effect - Clinical Code No Information (3190)
Date of Event 09/12/2017
Type of Reportable Event Malfunction
Additional Manufacturer Narrative
The incident sample has been requested but to date has not been received for evaluation.If the sample is received or if additional information pertinent to the incident is obtained a follow-up report will be submitted.
 
Event or Problem Description
According to the reporter, on (b)(6) during insertion, the device¿s guide wire was broken at the tip making it unable to insert the dilatator on it.As a result, the procedure was extended.Patient outcome is unknown at this time.
 
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Brand Name
PALINDROME
Common Device Name
CATHETER, HEMODIALYSIS, IMPLANTED
Manufacturer (Section D)
COVIDIEN MFG SOLUTIONS S.A.
edificio b20, calle #2
alajuela 20101
MDR Report Key6961001
Report Number3009211636-2017-05327
Device Sequence Number1209478
Product Code MSD
UDI-Device Identifier20884521158495
UDI-Public20884521158495
Combination Product (Y/N)N
Initial Reporter CountryFR
PMA/510(K) Number
K123196
Number of Events Summarized1
Summary Report (Y/N)N
Device Implanted Year2017
Reporter Type Manufacturer
Report Source company representative,foreig
Initial Reporter Occupation Other
Type of Report Initial
Report Date (Section B) 10/19/2017
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
Operator of Device Health Professional
Device Expiration Date08/31/2020
Device Model Number8888541019P
Device Catalogue Number8888541019P
Device Lot Number1704500100
Was Device Available for Evaluation? No
Type of Report(Section G)Thirty-Day
Initial Date Received by Manufacturer 10/03/2017
Initial Report FDA Received Date10/19/2017
Is This a Single-Use Device that was
Reprocessed and Reused on a Patient? (Y/N)		 No
Patient Sequence Number1
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