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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: CORDIS CORPORATION OPTEASE RETRIEVABLE VENA CAVA FILTER - 55CM-EU THROMBECTOMY SYSTEMS (DTK)

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CORDIS CORPORATION OPTEASE RETRIEVABLE VENA CAVA FILTER - 55CM-EU THROMBECTOMY SYSTEMS (DTK) Back to Search Results
Catalog Number 466F210A
Device Problems Shaft (955); Difficult to Remove (1528); Catheter (3038)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 02/23/2016
Event Type  Injury  
Manufacturer Narrative

(b)(6). The product was returned for evaluation and testing; however, the engineering evaluation is not complete. Additional information will be submitted within 30 days upon receipt.

 
Event Description

As reported, the optease retrievable filter was loaded/advanced into the catheter sheath introducer (csi) and became stuck in the middle of the sheath. The system was withdrawn from the patient. After removal from the patient, the sheath was cut for inserting a guidewire. There was no reported patient injury. The product will be returned for inspection. Additional information received indicated that the sheath mentioned in the event description (ed) was the sheath that comes with the kit/complaint product. The issue with the sheath was not thought to be blockage of the device with possibly injectable foreign material. There was no reported problem flushing the sheath prior to use in the patient. The sheath mentioned in the ed is not being returned for inspection with the complaint product and the inferior vena cava (ivc) long sheath was used for the procedure. The sheath used and mentioned in the ed was cut because the physician wanted to use the same puncture site instead of puncture a new wound. So he pulled back the sheath until the ivc filter was seen on the shaft and he then cut the shaft. Then the remaining part remained the wound site. The physician then inserted a 0. 035 guidewire, to retrieve the remaining part of device in the sheath. He then inserted a new ivc long sheath over the 0. 035 guidewire and continued doing the procedure. There was no reported difficulty obtaining vascular access or inserting the sheath. The patient was not noted to have a lot of thrombus near the insertion site. A new optease filter was used to complete the procedure successfully without patient injury. The indication for filter insertion was deep vein thrombosis (dvt). The size and shape of the vena cava was reported to be three (3) cm. And normal shape. There was no thrombus reported to be present at the delivery site. There were no other peri-procedure or post-procedure complications reported. There was no other product issue noted either at the account after the procedure or prior to shipping for inspection. No information was provided regarding: anticoagulation therapy, contradiction for anticoagulation, recurrent pulmonary embolus (pe) in spite of anticoagulation, or if pre/post imaging was completed. No additional information is available. Addendum: the product was received. Preliminary comments indicated that the device was received in pieces with detached stent. Device will be flushed, decontaminated and sent to (b)(4).

 
Manufacturer Narrative

As reported, during treatment for deep vein thrombosis (dvt) the optease retrievable filter was loaded/advanced into the catheter sheath introducer (csi) and became stuck in the middle of the sheath. The system was withdrawn from the patient. After partial removal from the patient, the sheath was cut for inserting a guidewire because ¿the physician wanted to use the same puncture site instead of puncture a new wound. ¿ so he pulled back the sheath until the ivc filter was seen on the shaft and he then cut the shaft. Then a part of the sheath remained the wound site. The physician then inserted a 0. 035 guidewire, to retrieve the remaining part of device in the sheath. He then inserted a new ivc long sheath over the 0. 035 guidewire and continued doing the procedure. A new optease filter was used to complete the procedure successfully without patient injury. There was no reported problem flushing the sheath prior to use in the patient. There was no reported difficulty obtaining vascular access or inserting the sheath. The patient was not noted to have a lot of thrombus near the insertion site. The size and shape of the vena cava was reported to be three (3) cm. And normal shape. There was no thrombus reported to be present at the delivery site. There were no other peri-procedure or post-procedure complications reported. The issue with the sheath was not thought to be blockage of the device with possibly injectable foreign material. There was no other product issue noted either at the account after the procedure or prior to shipping for inspection. No information was provided regarding: anticoagulation therapy, contradiction for anticoagulation, recurrent pulmonary embolus (pe) in spite of anticoagulation, or if pre/post imaging was completed. No additional information is available. Upon receipt of the device for analysis, the device was noted to be in pieces with detached stent. A non-sterile optease retrievable filter was received fully expanded along with the storage tube, the obturator and the catheter sheath introducer inside a plastic bag. Per visual analysis, the catheter sheath introducer was received cut at 10. 8cm from cannula distal end. No anomalies/ damages were found on the received obturator nor on the storage tube or on the filter. The received obturator and a lab sample 6f vessel dilator were successfully inserted through both separated pieces if csi cannula. However, the functional analysis to insert the received filter through the received cannula could not be performed since the filter was received fully deployed and expanded and the csi unit was received cut at 10. 8cm from cannula distal end. The optease filter barbs were inspected under microscope and no anomalies/damages were found. The csi cannula id was measured and results were found within specification. Also the filter hook od was measured and results were found within specification. Review of lot 17247798 revealed no anomalies during the manufacturing and inspection processes that can be associated with the reported complaint. The complaint reported by the customer ¿thrombectomy systems- filter- impeded¿, ¿thrombectomy systems- catheter - obstructed¿ and ¿catheter (body/shaft) (optease retrieval catheter) - withdrawal difficulty-through sheath¿ was not confirmed as the measurements taken during analysis found the device components within specification. The customer reported that the shaft was ¿cut¿ in order to maintain the puncture site; as such, the device was returned separated. The customer reported no difficulty obtaining vascular access and a normal size and shape of the vena cava. Based on the information available, a clinical conclusion regarding contributing factors of this event could not be conclusively determined. Neither the dhr nor the analysis suggest a design or manufacturing related cause for the difficulty experienced by the customer; therefore, no corrective action will be taken at this time.

 
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Brand NameOPTEASE RETRIEVABLE VENA CAVA FILTER - 55CM-EU
Type of DeviceTHROMBECTOMY SYSTEMS (DTK)
Manufacturer (Section D)
CORDIS CORPORATION
14201 nw 60th avenue
miami lakes FL
Manufacturer Contact
cecil navajas
circuito interior norte #1820
juarez chihuahua 32580
MX   32580
7863133880
MDR Report Key5500981
MDR Text Key40344533
Report Number9616099-2016-00131
Device Sequence Number1
Product Code DTK
Combination Product (Y/N)N
Reporter Country CodeHK
PMA/PMN NumberK023116
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type COMPANY REPRESENTATIVE,FOREIG
Reporter Occupation HEALTH PROFESSIONAL
Type of Report Initial,Followup
Report Date 02/23/2016
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received03/15/2016
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device EXPIRATION Date04/30/2018
Device Catalogue Number466F210A
Device LOT Number17247798
Was Device Available For Evaluation? Device Returned To Manufacturer
Date Returned to Manufacturer03/03/2016
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received04/05/2016
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Date Device Manufactured05/21/2015
Is The Device Single Use? Yes
Is this a Reprocessed and Reused Single-Use Device?
Type of Device Usage Initial

Patient TREATMENT DATA
Date Received: 03/15/2016 Patient Sequence Number: 1
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