CORDIS NEUROVASCULAR, INC. TRUFILL DCS ORBIT DETACHABLE COILS COMPLEX; CNV DCS ORBIT (HCG)
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Catalog Number 638CS1230 |
Device Problem
Impedance Problem (2950)
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Patient Problem
No Consequences Or Impact To Patient (2199)
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Event Date 03/12/2014 |
Event Type
malfunction
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Event Description
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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.
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Manufacturer Narrative
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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.
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Manufacturer Narrative
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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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