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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: WILLIAM COOK EUROPE COOK CELECT® PLATINUM NAVALIGN UNISET VENA CAVA FILTER SET DTK FILTER, INTRAVASCULAR, CARDIOVASCULAR

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WILLIAM COOK EUROPE COOK CELECT® PLATINUM NAVALIGN UNISET VENA CAVA FILTER SET DTK FILTER, INTRAVASCULAR, CARDIOVASCULAR Back to Search Results
Catalog Number IGTCFS-65-1-UNI-CELECT-PT
Device Problems Tube (525); Crack (1135); Fluid Leak (1250)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 04/11/2016
Event Type  Malfunction  
Manufacturer Narrative

(b)(4). Catalog #: igtcfs-65-1-uni-celect-pt. Investigation is still in progress.

 
Event Description

Description of event according to complainant: they hooked up the power injector to the dilator. They did a run and went to detach the tubing from the dilator. At this point, the plastic hub of the dilator cracked causing blood leakage. The dilator could not be used. They successfully completed procedure with another filter set. Patient outcome: the patient did not require any additional procedures due to this occurrence. According to the initial reporter, the patient did not experience any adverse effects due to this occurrence.

 
Manufacturer Narrative

(b)(4). Catalog: igtcfs-65-1-uni-celect-pt. Summary of investigational findings: from the image of the device received it is verified that the shells have separated. When using a power injector, hardened contrast can cause the fitting of the connection tube to stick to the dilator fitting. If sticking, the dilator fitting may separate and consequently the dilator shells may open when attempts are made to disconnect the connection tube from the dilator. It is noted that the event did not harm the patient and that the procedure was completed successfully using a new device. There is no evidence to suggest that the device with separated shells was not manufactured according to specifications. Cook medical will continue to monitor for similar events.

 
Event Description

Description of event according to complainant: they hooked up the power injector to the dilator. They did a run and went to detach the tubing from the dilator. At this point, the plastic hub of the dilator cracked causing blood leakage. The dilator could not be used. They successfully completed procedure with another filter set. Patient outcome: the patient did not require any additional procedures due to this occurrence. According to the initial reporter, the patient did not experience any adverse effects due to this occurrence.

 
Manufacturer Narrative

(b)(4). Catalog#: igtcfs-65-1-uni-celect-pt. (b)(4). Date of expiration: 12apr2016. Description of event according to complainant: they hooked up the power injector to the dilator. They did a run and went to detach the tubing from the dilator. At this point, the plastic hub of the dilator cracked causing blood leakage. The dilator could not be used. They successfully completed procedure with another filter set. Patient outcome: the patient did not require any additional procedures due to this occurrence. According to the initial reporter, the patient did not experience any adverse effects due to this occurrence. (b)(4). Catalog: igtcfs-65-1-uni-celect-pt. Operator of device: health professional. Device received on 20jun2016. (b)(6). Summary of investigational findings: investigation of returned device: only the dilator was returned and investigation found the hub had cracked as reported; the shells had separated and marks from a pean were noted on two sides of the luer. Also, the luer had separated from the cap. Based on these findings it is suggested that the dilator hub was firmly secured during attempts to remove the injection and by doing so, the luer itself was turned and caused the shells to separate. Remains of glue were noted on the luer thread, which is according to specifications, so investigation found no evidence to suggest product was not manufactured according to specifications. Investigation final comments: from the image and returned device it is verified that the shells have separated. When using a power injector, hardened contrast can cause the fitting of the connection tube to stick to the dilator fitting. If sticking, the dilator fitting may separate and consequently the dilator shells may open when attempts are made to disconnect the connection tube from the dilator. It is noted that the event did not harm the patient and that the procedure was completed successfully. There is no evidence to suggest that the device with separated shells was not manufactured according to specifications. Cook medical will continue to monitor for similar events.

 
Event Description

Description of event according to complainant: they hooked up the power injector to the dilator. They did a run and went to detach the tubing from the dilator. At this point, the plastic hub of the dilator cracked causing blood leakage. The dilator could not be used. They successfully completed procedure with another filter set. Additional information received from customer report to fda, ref# (b)(4): component of ivc filter placement kit came apart. The hub of the dilator came apart. The device was removed and new kit was used. The patient was not harmed. Manufacturer response for iv filter kit, cook celect platinum vena cava filter. Patient outcome: the patient did not require any additional procedures due to this occurrence. According to the initial reporter, the patient did not experience any adverse effects due to this occurrence. Additional information received from customer report to fda, ref# (b)(4): the patient was not harmed.

 
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Brand NameCOOK CELECT® PLATINUM NAVALIGN UNISET VENA CAVA FILTER SET
Type of DeviceDTK FILTER, INTRAVASCULAR, CARDIOVASCULAR
Manufacturer (Section D)
WILLIAM COOK EUROPE
4632 bjaeverskov
DA
Manufacturer Contact
marianne hoey
sandet 6
bjaeverskov 4632
DA   4632
56868686
MDR Report Key5589958
MDR Text Key44213063
Report Number3002808486-2016-00237
Device Sequence Number1
Product Code DTK
Combination Product (Y/N)N
Reporter Country CodeUS
PMA/PMN NumberK121629
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type COMPANY REPRESENTATIVE,HEALTH
Reporter Occupation
Type of Report Initial,Followup,Followup
Report Date 04/12/2016
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received04/20/2016
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device Catalogue NumberIGTCFS-65-1-UNI-CELECT-PT
Was Device Available For Evaluation? Yes
Is The Reporter A Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received04/12/2016
Was Device Evaluated By Manufacturer? Yes
Date Device Manufactured02/16/2016
Is The Device Single Use? Yes
Is this a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

Patient TREATMENT DATA
Date Received: 04/20/2016 Patient Sequence Number: 1
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