MAUDE Adverse Event Report: CORDIS CORPORATION OUTBACK RE-ENTRY CATHETER; CTO CATHETER SYSTEMS (DQY)

Catalog Number OTB42120

Device Problem Unraveled Material (1664)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 02/23/2016

Event Type  malfunction  

Manufacturer Narrative

This device is available for analysis but the engineering report is not yet available.However, it will be submitted within 30 days upon receipt.This is one of 2 products involved with the reported event and the associated manufacturer report numbers are 9616099-2016-00135 and 9616099-2016-00136,.

Event Description

It was reported that during an unspecified interventional procedure an outback was removed from the patient but could not be re-inserted due to resistance and it could not be flushed.The wire of this device was reported to be frayed a second outback ltc was used instead and was used successfully but there was difficulty withdrawing the device and the tip separated during removal requiring snared out.The devices were returned for analysis and the preliminary comments of the device with lot 17288024 indicate that it was received with the "coil stretched 2 cm.The procedure being performed was left popliteal percutaneous transluminal angioplasty (pta) with stenting with heavy calcification.Access was via the right femoral.Proper orientation was confirmed under fluoro prior to actuation of the cannula.There was difficulty advancing the outback from over the aortic bifurcation, therefore, the terumo 6fx45cm sheath was changed to cook flexor 7fx55cm sheath.There was no difficulty advancing the tip to reentry level.While torquing the device during placement, the black handle was held, and the rotator knob was used to rotate.The device was not responding readily to torquing due to calcification, but it did.A clicking sound was not heard.The user did not hold onto the luer hub assembly located in front of the black handle while torquing the device.The tip was not stuck in the lesion while torquing and there was no difficulty/resistance actuating the product.The ¿l¿ marker leg, on the catheter ¿lt¿ directional marker band, towards the target re-entry site was verified using an initial fluoroscopic view.It is not known if the stored torque in the catheter shaft released after the cannula tip was properly positioned.The ¿lt¿ directional marker band slot was oriented toward the desired vascular location (target site) prior to actuation of the handle deployment slide.Once at the lesion the cannula/needle actuated smoothly.The physician was not able to re-enter the vessel with the guidewire at the desired location.There was no resistance or difficulty removing the first outback from the patient but there was with the second device.More force than usual was required.The cannula was retracted prior to catheter withdrawal.The tip broke off at the aortic bifurcation in the sheath.Another 0.014 wire was placed alongside the tip into the artery, and the sheath was removed with the tip in place.Inexplicably, they remained in the right iliac artery and did not come out with the 7f sheath.The femoral artery was accessed with a shorter 7f sheath, and the tip was snared with a goose snare.No excessive force was needed to remove them (including the device with lot 17288024).A narrative was provided that the left popliteal artery occlusion was very calcified and could not be reentered (fig 1).The physician placed the 0.014 wire, and advanced the first outback, but the sheath (terumo 6f x45cm) was buckling into the aorta, and the outback tip was not advancing.The physician then changed the sheath to a flexor 7fx55cm sheath, and this allowed delivery of the outback to the distal target.The user felt like one of the main issue was that the needle was not breaking through the heavily calcified lumen.Finally, he seemed to have entered, removed the outback without any difficulty however, when checking, noted that the 0.014 wire advanced and reentered at a more distal site.This was likely because the needle somehow let the physician in a plane that allowed the wire to mode distally, and somehow reentered in more distal popliteal artery.The physician decided to retry and enter more proximally.When trying to reinsert the outback, it was noted that it was very resistant, and they could not actually flush the outback.So, they opened the second outback, and advanced to target without difficulty.Despite multiple attempts, they could not reenter the lumen.The user then decided to stop and attempted retrograde canalization.However, the outback was very hard to remove and when it was pulled out, it was noticed that the tip was broken and stuck at the bifurcation, within the 7f sheath.In order not to lose access, the user placed an all start 0.014 wire alongside the tip, and passed it distally, and slowly removed the sheath under fluoro, which looked like the tip was coming out with the sheath.The physician must have not seen it come all the way out from the right side, and when the sheath was checked, the tip was not there.It dislodges and was in the iliac artery.The user reinserted a 7f sheath over the 0.014 wire, and then attempted snaring the tip.It was easy to catch, but could not get it into the sheath.As the user was contemplating to have a larger sheath, it was noted that the snare caught something and the tip launched into the sheath in line, and it was removed.However, it was noted that there was the frayed wire that the snare caught and pulled into the sheath.Six angiographic images were provided by the site.The first of these images appears to depict a highly calcified and totally occluded left sfa/popliteal artery lesion.The second and third images depict the same lesion with an outback re-entry catheter across the target lesion and in the subintimal space.Of note, the ¿lt¿ directional marker is in the ¿l¿ position in this view.It is unclear whether these two images are of the same or different outback devices.The fourth image depicts a separated distal tip of an outback catheter in the patient¿s right iliac artery outside of a catheter sheath introducer.The fifth image appears to depict an attempt to snare a separated distal tip of the outback device.The sixth image appears to depict the successful snaring of a separated distal tip of the outback device into the catheter sheath introducer.

Manufacturer Narrative

A report was received that an outback ltd re-entry catheter could not be re-inserted into the patient due to resistance and could not be flushed.In addition, the wire of the device was noted to be frayed.A second outback ltd re-entry catheter was then used successfully but resistance was experienced while withdrawing the device and its¿ distal tip separated from the catheter within the patient.The retained portion was successfully snared with no reported patient injury.The event involved a (b)(6) patient with a past medical history of hypertension, diabetes mellitus, smoking, coronary artery disease, cerebral vascular accident with residual right-sided weakness, peripheral arterial disease with bilateral non-healing diabetic foot ulcers.He had recently undergone angioplasty and stenting of the right superficial femoral artery and infrapopliteal region one month earlier and was returning for revascularization of the left leg.Angiogram revealed a target lesion in the left proximal popliteal artery that was described as heavily calcified and 3cm in length.The patient¿s vasculature was accessed via a contralateral approach via the right femoral artery with a 6fr 45cm terumo catheter sheath introducer and an 0.014¿ guidewire was advanced towards the lesion.Difficulty was experienced while advancing the first outback catheter over the aortic bifurcation with buckling of the 6fr sheath noted.The outback was then removed and the sheath exchanged for a 7fr 55cm non-cordis sheath.No further difficulty was experienced when advancing the re-inserted outback catheter towards the lesion.The site reported that while advancing and torquing this device, the black handle was held and the rotator knob was used to rotate it.The user did not hold onto the luer hub assembly during these maneuvers.The device was not responding readily to torquing due to vessel calcification, but it did.They confirmed that a clicking sound was not heard.Proper orientation of the cannula was confirmed with the use of fluoroscopy prior to deploying the cannula.The deployment slide was successful moved with no difficulty or resistance.However, the physician was not able to re-enter the vessel with the guidewire at the desired location.The user felt like one of the main issue was that the needle was not breaking through the heavily calcified lumen.Finally, he seemed to have entered but noted that the 0.014¿ guidewire advanced and reentered at a more distal site.At this point the physician opted to remove the device in order to enter more proximally.No difficulty or resistance was experienced while withdrawing the device from the patient.Once removed, the device could not be flushed and it was very difficult to re-insert the device into the patient.A second device was then advanced into the patient without difficulty.Multiple attempts to re-enter the true lumen with the cannula needle were unsuccessful.Difficulty was experienced while removing the device with more force than usual required.During the removal of the device, the distal tip of the catheter of the outback was noted to have broken off in the aortic bifurcation within the sheath.Another 0.014¿ guidewire was placed alongside the separated tip and the 7fr 55cm non-cordis sheath removed with the device under fluoroscopy; leaving the additional guidewire in place to preserve access.Despite these maneuvers, the distal tip of the outback was noted to still be in the right iliac artery.The femoral artery was then accessed with a shorter 7fr sheath.Attempts to snare the distal tip were complicated by a frayed wire on the distal tip getting caught in the sheath.At this point, the user was able to remove the sheath with the distal tip.Six angiographic images were provided by the site.The first of these images appears to depict a highly calcified and totally occluded left sfa/popliteal artery lesion.The second and third images depict the same lesion with an outback re-entry catheter across the target lesion and in the subintimal space.Of note, the ¿lt¿ directional marker is in the ¿l¿ position in this view.It is unclear whether these two images are of the same or different outback devices.The fourth image depicts a separated distal tip of an outback catheter in the patient¿s right iliac artery outside of a catheter sheath introducer.The fifth image appears to depict an attempt to snare a separated distal tip of the outback device.The sixth image appears to depict the successful snaring of a separated distal tip of the outback device into the catheter sheath introducer.One non sterile outback was received coiled inside a plastic bag.The distal catheter was separated from the shaft, the coil wire was unraveled stretched and the cannula needle was uncovered at the rupture point.No other damages were noted in the device.Functional testing of the cannula deployment process could not be performed due to the condition of the returned device.Sem analysis of the separated section of the catheter body revealed plastic deformation resulting in elongations.The elongations observed presented evidence of the application of a tension force that induced the separation.Also the braid wire presented evidence of a plastic deformation that can suggest an application of stress that exceeds the material yield strength or a tensile overload.In addition, ductile dimples were found that can suggest pulling / stretching events prior to separation.A review of the manufacturing records for this lot of products revealed that it met specification prior to release.The reported ¿catheter (body/shaft) ¿ unraveled/stretched¿ event for the first device was confirmed based on the visual analysis; while the ¿cto catheter system ¿ retraction difficulty¿ event could not be confirmed since functional testing could not be performed because of the condition of the returned device.The cause of this event could not be conclusively determined.However, the results of the sem analysis suggest that procedural and handling factors may have contributed to it.The reported ¿cto catheter system ¿ withdrawal difficulty-from vessel¿ and catheter (body/shaft) ¿ fractured/ separated-in patient¿ events for the second device were confirmed based on the results of the visual analysis.The cause of these events could not be conclusively determined; but the results of the sem analysis suggest that procedural and/or handling factors may have contributed to them.The product instructions for use (ifu) cautions the users that excessive calcification at the site or re-entry may impair performance.It instructs users that if resistance is felt during cannula deployment, they are to not apply unnecessary forward push on the device since this may result in damage to the cannula tip and/or separation of the cannula tip.If further instructs the user to always visualize tracking of the catheter tip over the aorto-iliac bifurcation.The ifu recommends that if strong resistance is felt during catheter manipulation/delivery, determine the cause of the resistance before proceeding further.Excessive rotation, bending or kinking of the outback catheter may affect its¿ performance.The ifu instructs the user to withdraw the catheter if it becomes excessively kinked.Tracking the outback through an acute vessel angle, such as the aorto-iliac bifurcation, may have contributed to the reported events.Based on the information available for review, there are vessel characteristics (calcification) and procedural factors (difficulty experienced during advancement of the first device and withdrawal of the second device) that may have contributed to the reported events.Neither the device history record reviews nor the product analyses of the devices suggest that the reported event were related to the manufacturing process.Therefore, no corrective actions will be taken at this time.This is one of 2 products involved with the reported event and the associated manufacturer report numbers are 9616099-2016-00135 and 9616099-2016-00136.

• Brand Name: OUTBACK RE-ENTRY CATHETER
• Type of Device: CTO CATHETER SYSTEMS (DQY)
• 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: 5505311
• MDR Text Key: 40534848
• Report Number: 9616099-2016-00136
• Device Sequence Number: 1
• Product Code: PDU
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K043534
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Health Professional
• Type of Report: Initial,Followup
• Report Date: 02/24/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/16/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 06/30/2017
• Device Catalogue Number: OTB42120
• Device Lot Number: 17288024
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/02/2016
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/21/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/27/2015
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Age: 72 YR