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

Catalog Number 466F210A

Device Problems Detachment Of Device Component (1104); Fracture (1260)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 09/23/2015

Event Type  malfunction  

Manufacturer Narrative

Please note that the gender of the patient is unknown.(b)(6).(b)(4).The device has been returned for analysis; but the engineering report is not yet available.However, it will be reported within 30 days upon receipt.A device history record (dhr) review could not be conducted as a valid lot number was not provided ((b)(4)).Additional information is pending and will be submitted within 30 days upon receipt.

Event Description

As reported, "did not operated filter." occurred during use on patient.Event or product problem outcome is unknown.Additional information was received by the decontamination site: "sheath received in two.Filter detached and included.".

Manufacturer Narrative

Additional information was provided: the issue of the separation was reported through the sales rep.It is unknown when in the procedure the separation occurred.It is unknown if the filter was in the sheath when it separated.However, it was reported that the device separated in two pieces while in the patient and a snare was used to remove the separated segment.The sheath was not purposefully cut in two pieces.It is unknown if the sheath was pulled against resistance or if it was kinked/bent at the area of separation.The sales rep heard that the physician tore the sheath because filter device did not move.The was no patient injury.The analysis site has reported that a strut of the filter was fractured.The device has been received for analysis, but the engineering report is not yet available.However, it will be submitted within 30 days upon receipt.A device history record (dhr) review and additional information are pending and will be submitted within 30 days upon receipt.

Manufacturer Narrative

Complaint conclusion: it was reported that during use in the patient, the sheath separated in the patient and the separated segment was retrieved by snare.It is unknown if the filter was within the sheath at the point when separation occurred.There was no residual patient injury reported.The sheath was not purposefully cut in two pieces.It is unknown if the sheath was pulled against resistance or if it was kinked/bent at the area of separation.The reporter noted that the physician may have torn the sheath because filter device did not move.Analysis of the returned device also noted a fracture of the filter.One sterile unit of optease retrievable filter was received inside of a plastic bag.A brite tip catheter sheath introducer, obturator, storage tube and filter were received.The cannula from catheter sheath introducer was received in two pieces.A kink condition was observed on the obturator at 5.5 cm from distal tip.There were no storage tube damages observed.The filter was received deployed and a broken condition was observed on strut.The filter was inspected under vision system and one strut was received broken no another damages were observed on it.The filter was returned to ndc for analysis: performed a sem analysis to filter and based on the fracture analysis, there is no conclusive evidence showing fractures were caused by deviations in the ndc manufacturing processes.Fracture analysis concluded that the part had an excess torqueing force that may have caused both fractures and additional cracks on the part to occur.Sem analysis was performed to cannula and results showed that the cannula external surface presented evidence of stress and cutting characteristics at the surroundings of the separation.Cutting could have been related to this separation characteristic.It is possible that an unknown sharp object made the cut to the cannula.Functional analysis cannot be performed due to the fracture observed on the filter and cannula from catheter sheath introducer received in two pieces.Lot number was not provide, dhr history record could not be performed.The complaint reported by the customer as ¿filter/ fractured¿ was confirmed as the filter was received fractured.While the exact cause could not be determined, the sem analysis concluded that the part had an excess torqueing force that may have caused both fractures and additional cracks on the part to occur.The ¿filter/ impeded-in patient¿ could not be confirmed as the filter was received deployed and broken.¿catheter sheath introducer (csi)/ separated-in patient¿ was confirmed as the cannula was received in two pieces.Again the root cause could not be determined; however, sem analysis determined that cutting could have been related to this separation characteristic.The cause of the failures experience by the customer could not be conclusively determined; however, procedural and or handling factors may have contributed to the difficulty experienced.The instructions for use precautions ¿advancement, manipulation and withdrawal of the optease filter or its accessories should always be performed under fluoroscopic guidance.If strong resistance is met during any stage of the procedure, discontinue the procedure and determine the cause before proceeding.¿ neither the analysis nor the information available for review suggests that the failures reported could be related to the manufacturing process.Therefore no corrective and preventive actions will be taken at this time.

• Brand Name: OPTEASE RETRIEVABLE VENA CAVA FILTER - 55CM-EU
• Type of Device: THROMBECTOMY 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 Key: 5245876
• MDR Text Key: 32009126
• Report Number: 9616099-2015-00599
• Device Sequence Number: 1
• Product Code: DTK
• Combination Product (y/n): N
• Reporter Country Code: KN
• PMA/PMN Number: K023116
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Health Professional
• Type of Report: Initial,Followup,Followup
• Report Date: 09/23/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/24/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 466F210A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/04/2015
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/06/2016
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1