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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: WILLIAM COOK EUROPE FLIPPER 110 PDA CLOSURE COIL DELIVERY SYSTEM DTK FILTER, INTRAVASCULAR, CARDIOVASCULAR

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WILLIAM COOK EUROPE FLIPPER 110 PDA CLOSURE COIL DELIVERY SYSTEM DTK FILTER, INTRAVASCULAR, CARDIOVASCULAR Back to Search Results
Catalog Number TDS-110-PDA
Device Problems Activation, Positioning or SeparationProblem (2906); Premature Separation (4045)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 08/24/2018
Event Type  Malfunction  
Manufacturer Narrative

(b)(4). Blank fields on this form indicate the information is unknown or unavailable. (b)(4). Similar to device under 510(k) k150964. (b)(4). Investigation is still in progress.

 
Event Description

The device was used for embolization to treat pda by femoral approach. The coil could not be connected with the tds properly, so the coil became detached from the tds inside a catheter. Since the physician thought it would be risky to continue to use the devices, he replaced them with new ones and completed the procedure. There have been no adverse effects to the patient reported.

 
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Brand NameFLIPPER 110 PDA CLOSURE COIL DELIVERY SYSTEM
Type of DeviceDTK FILTER, INTRAVASCULAR, CARDIOVASCULAR
Manufacturer (Section D)
WILLIAM COOK EUROPE
sandet 6
bjaeverskov 4632
DA 4632
Manufacturer (Section G)
WILLIAM COOK EUROPE
sandet 6
bjaeverskov DK-46 32
DA DK-4632
Manufacturer Contact
thomas hessner kirk
sandet 6
bjaeverskov DK-46-32
DA   DK-4632
56868686
MDR Report Key7867757
MDR Text Key119938620
Report Number3002808486-2018-01068
Device Sequence Number1
Product Code DTK
Combination Product (Y/N)N
Reporter Country CodeJA
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type FOREIGN,HEALTH PROFESSIONAL,O
Reporter Occupation
Type of Report Initial,Followup,Followup
Report Date 02/21/2019
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received09/12/2018
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device Catalogue NumberTDS-110-PDA
Device LOT NumberE3751142
Was Device Available For Evaluation? Device Returned To Manufacturer
Date Returned to Manufacturer09/06/2018
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA?
Distributor Facility Aware Date08/29/2018
Device Age1 mo
Event Location No Information
Date Manufacturer Received01/28/2019
Was Device Evaluated By Manufacturer? Yes
Date Device Manufactured07/18/2018
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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