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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: CORDIS NEUROVASCULAR, INC. TRUFILL DCS ORBIT DETACHABLE COILS COMPLEX; CNV DCS ORBIT (HCG)
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CORDIS NEUROVASCULAR, INC. TRUFILL DCS ORBIT DETACHABLE COILS COMPLEX; CNV DCS ORBIT (HCG) Back to Search Results
Catalog Number 638CS1230
Device Problem Impedance Problem (2950)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 03/12/2014
Event Type  malfunction  
Event Description
The complaint received states that during use an orbit (638cs1230/15784585, complaint product) had resistance/friction, kinked and failed to deploy.The procedure was coil embolisation of right internal iliac artery that was mildly calcified and heavily tortuous.The patient was a male of 77 years old.Dob and weight unknown.Access was obtained from right femoral artery.During the procedure, while advancing an orbit (638cs1230/15784585, complaint product) in an unspecified prowler select plus (catalogue and lot unknown), the physician experienced severe resistance around the distal section of the microcatheter.However, as he continued to advance the coil into the microcatheter, the delivery tube of the orbit appeared to be kinked.The report did not indicate where on the delivery tube the kink was located.Then, the orbit was finally delivered into the target lesion and attempted the detachment using the dcs syringe ii (635-002, lot unknown).Although he attempted the detachment of the orbit several times, it would not be detached at the green zone.Then, he attempted the detachment at the red alternative detachment zone several times, the situation was same.And then, the orbit was safely removed from the patient.After withdrawal, the orbit was outside the patient; the delivery tube of the orbit was damaged and separated in two pieces.The report did not indicate which part of the delivery tube the damage occurred also.After that, the procedure was continued using a new product (638cs1230, lot unknown) and he was able to detach the replaced coil into the target lesion with no further issues.Afterwards, the procedure was successfully completed without any further issues.There was no patient injury/complications reported.
 
Manufacturer Narrative
Additional information will be submitted within 30 days of receipt.Prior to the complaint product, five coils (638cs1430 total 3, 638cs1230 total 2, lot all unknown) were successfully detached and placed into the target lesion with no further issues.It is unknown if the syringe was replaced or not.It is also unknown how many syringes were used to detach the coil during the procedure.The complaint product was new and was stored per labeling instructions.
 
Manufacturer Narrative
The complaint received states that during use an orbit (638cs1230/15784585, complaint product) had resistance/friction, kinked and failed to deploy.The procedure was coil embolisation of right internal iliac artery that was mildly calcified and heavily tortuous.The patient was a male of (b)(6).Dob and weight unknown.Access was obtained from right femoral artery.During the procedure, while advancing an orbit (638cs1230/15784585, complaint product) in an unspecified prowler select plus (catalogue and lot unknown), the physician experienced severe resistance around the distal section of the microcatheter.However, as he continued to advance the coil into the microcatheter, the delivery tube of the orbit appeared to be kinked.The report did not indicate where on the delivery tube the kink was located.Then, the orbit was finally delivered into the target lesion and attempted the detachment using the dcs syringe ii (635-002, lot unknown).Although he attempted the detachment of the orbit several times, it would not be detached at the green zone.Then, he attempted the detachment at the red alternative detachment zone several times, the situation was same.And then, the orbit was safely removed from the patient.After withdrawal, the orbit was outside the patient; the delivery tube of the orbit was damaged and separated in two pieces.The report did not indicate which part of the delivery tube the damage occurred also.After that, the procedure was continued using a new product (638cs1230, lot unknown) and he was able to detach the replaced coil into the target lesion with no further issues.Afterwards, the procedure was successfully completed without any further issues.There was no patient injury/complications reported.Prior to the complaint product, five coils (638cs1430 total 3, 638cs1230 total 2, lot all unknown) were successfully detached and placed into the target lesion with no further issues.It is unknown if the syringe was replaced or not.It is also unknown how many syringes were used to detach the coil during the procedure.The complaint product was new and was stored per labeling instructions.Review of lot 15784585 revealed no anomalies during the manufacturing and inspection processes that can be associated with the reported complaint.With the information available and without the product available for analysis the complaint could not be confirmed.Inspections are in place to prevent damaged products from leaving the facility and the dhr review confirmed that the product met specifications.No corrective action is required at this time.It is difficult to draw a clinical conclusion between the device and the event based on the limited information available.
 
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Brand Name
TRUFILL DCS ORBIT DETACHABLE COILS COMPLEX
Type of Device
CNV DCS ORBIT (HCG)
Manufacturer (Section D)
CORDIS NEUROVASCULAR, INC.
14700 nw 57th court
miami lakes FL 33014
Manufacturer (Section G)
CODMAN AND SHURTLEFF, INC (SAN JOSE)
821 fox lane
san jose CA 95131
Manufacturer Contact
denise singleton
miami lakes, FL 33014
4084331514
MDR Report Key3711241
MDR Text Key4234252
Report Number1058196-2014-00110
Device Sequence Number1
Product Code HCG
Combination Product (y/n)N
Reporter Country CodeJA
PMA/PMN Number
K053197
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Foreign,Health Professional,Company Representative
Reporter Occupation Other
Type of Report Initial,Followup
Report Date 03/13/2014
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received03/31/2014
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Expiration Date12/31/2014
Device Catalogue Number638CS1230
Device Lot Number15784585
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer03/28/2014
Is the Reporter a Health Professional? No
Date Manufacturer Received04/08/2014
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured01/01/2013
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Removal/Correction NumberN/A
Patient Sequence Number1
Treatment
UNKNOWN PROWLER SELECT PLUS
Patient Age77 YR
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