MAUDE Adverse Event Report: CORDIS CORPORATION OUTBACK; CATHETER FOR CROSSING TOTAL OCCLUSIONS

Model Number OTB42120

Device Problem Device Dislodged or Dislocated (2923)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 04/14/2022

Event Type  Injury  

Event Description

As reported, the ¿l¿ marker of an outback ltd re-entry catheter 120cm, detached.It detached during use in the vessel and is in the vessel.The user is trained with the device.The device will be returned for evaluation.Addendum from additional info: the "l" marker was noted be dislodged.

Manufacturer Narrative

A review of the manufacturing documentation associated with lot 17947218 presented no issues during the manufacturing process that can be related to the reported event.Additional information is pending and will be submitted within 30 days upon receipt.

Manufacturer Narrative

A review of the manufacturing documentation associated with lot 17947218 presented no issues during the manufacturing process that can be related to the reported event.Additional information is pending and will be submitted within 30 days upon receipt.

Event Description

As reported, the ¿l¿ marker of an outback ltd re-entry catheter 120cm, detached/dislodged.It detached during use in the vessel and is in the vessel.The user is trained with the device.The needle remained intact and could be easily extended and retracted even after the outback had been removed.The handle release slider was locked.The outback was used and handled at all times on the basis of the ifu.The positioning of the outback in the sense of crossover access was problem-free.A relevant calcification of the vessel was also not present.The device will be returned for evaluation.Addendum from additional info: the "l" marker was noted be dislodged.It was not possible to remove the detached l-marker.After successful wire passage using the needle, the marker remained in the distal area of the afs for a few seconds but was then carried through the bloodstream into the tractus tibiofibularis.There a salvage did not succeed despite numerous attempts, by the salvage attempts the marker was dragged into the distal anterior fibularis.The previously open distal anterior fibularis was closed by the l-marker at the end of the examination.In this respect, there is certainly an undesirable event associated with the use of the outback.The patient (claudicantin) was discharged as scheduled the following day.Outpatient follow-ups with recording of clinical symptoms are planned via the referring practice.

Manufacturer Narrative

Additional information is pending and will be submitted within 30 days upon receipt.

Event Description

As reported, the ¿l¿ marker of an outback ltd re-entry catheter 120cm, detached/dislodged.It detached during use in the vessel and is in the vessel.The user is trained with the device.The needle remained intact and could be easily extended and retracted even after the outback had been removed.The handle release slider was locked.The outback was used and handled at all times on the basis of the ifu.The positioning of the outback in the sense of crossover access was problem-free.A relevant calcification of the vessel was also not present.The device will be returned for evaluation.Addendum from additional info: the "l" marker was noted be be dislodged.It was not possible to remove the detached l-marker.After successful wire passage using the needle, the marker remained in the distal area of the afs for a few seconds but was then carried through the bloodstream into the tractus tibiofibularis.There a salvage did not succeed despite numerous attempts, by the salvage attempts the marker was dragged into the distal anterior fibularis.The previously open distal anterior fibularis was closed by the l-marker at the end of the examination.In this respect, there is certainly an undesirable event associated with the use of the outback.The patient (claudicantin) was discharged as scheduled the following day.Outpatient follow-ups with recording of clinical symptoms are planned via the referring practice.

Event Description

As reported, the ¿l¿ marker of an outback ltd re-entry catheter 120cm, detached/dislodged.It detached during use in the vessel and is in the vessel.It was not possible to remove the detached l-marker.After successful wire passage using the needle, the marker remained in the distal area of the afs for a few seconds but was then carried through the bloodstream into the tractus tibiofibularis.There a salvage did not succeed despite numerous attempts, by the salvage attempts the marker was dragged into the distal anterior fibularis.The previously open distal anterior fibularis was closed by the l-marker at the end of the examination.The user is trained with the device.The needle remained intact and could be easily extended and retracted even after the outback had been removed.The handle release slider was locked.The outback was used and handled at all times on the basis of the ifu.The positioning of the outback in the sense of crossover access was problem-free.A relevant calcification of the vessel was also not present.The device will be returned for evaluation.The patient (claudicantin) was discharged as scheduled the following day.Outpatient follow-ups with recording of clinical symptoms are planned via the referring practice.External image review: six spot digital images are submitted for review.This complaint involves a patient undergoing endovascular treatment of a chronic distal sfa occlusion.While utilizing an outback re entry device the distal ¿l¿ marker fractured and was dislodged in the distal tibioperoneal artery.During attempted retrieval the fragment embolized distally into the distal peroneal artery and was unable to be retrieved.This event resulted in thrombosis of the peroneal artery.Although the patient did not experience immediate clinical impact from this even the long term consequence is unclear.The anterior tibial artery is the dominant vessel and was widely patent at the end of the procedure.The first image is a dsa image of the distal sfa.There is chronic occlusion of the distal sfa with multiple collateral vessels noted.An outback re entry device is being utilized to gain reentry into the above knee popliteal artery.The ¿l¿ marker is not visualized.The second image shows a wire extending into the below knee popliteal artery.At the level of the proximal tibial diaphysis the fractured ¿l¿ marker is seen.The third image is a dsa image of the lower leg.The fragment is seen in the distal tibioperoneal trunk extending into the peroneal artery.The anterior tibial artery is patent.The posterior tibial artery is patent.The fourth image is a dsa image of the ankle.The anterior tibial artery is patent.The posterior tibial artery occludes in the upper calf.The distal peroneal artery is patent.The fifth image shows the ¿l¿ fragment now in the lower calf; presumably in the distal peroneal artery.No contrast.The sixth image is a dsa showing the fragment in the distal peroneal artery in the lower calf.There is contrast within a diminutive distal peroneal artery.The anterior tibial artery is patent.

Manufacturer Narrative

After further review of additional information received the following sections have been updated accordingly: b5, g3, h1, h2, h3 and h6.As reported, the ¿l¿ marker of a 120cm outback ltd re-entry catheter detached/dislodged.It detached during use in the vessel and remained in the vessel.It was not possible to remove the detached l-marker.After successful wire passage using the needle, the marker remained in the distal area of the arteria femoris superficialis (afs) for a few seconds but was then carried through the bloodstream into the tractus tibiofibularis.There, a salvage did not succeed despite numerous attempts.By the salvage attempts, the marker was dragged into the distal anterior fibularis.The previously open distal anterior fibularis was closed by the l-marker at the end of the examination.The patient (claudicantin) was discharged as scheduled the following day.Outpatient follow-ups with recording of clinical symptoms are planned via the referring practice.The user was trained with the device.The needle remained intact and could be easily extended and retracted even after the outback had been removed.The handle release slider was locked.The outback was used and handled at all times on the basis of the instructions for use (ifu).The positioning of the outback in the sense of crossover access was problem-free.A relevant calcification of the vessel was also not present.Six digital images were submitted for review.Per the review by an independent physician, ¿six spot digital images are submitted for review.The first image is a dsa image of the distal sfa.There is chronic occlusion of the distal sfa with multiple collateral vessels noted.An outback reentry device is being utilized to gain reentry into the above knee popliteal artery.The ¿l¿ marker is not visualized.The second image shows a wire extending into the below knee popliteal artery.At the level of the proximal tibial diaphysis, the fractured ¿l¿ marker is seen.The third image is a dsa image of the lower leg.The fragment is seen in the distal tibioperoneal trunk extending into the peroneal artery.The anterior tibial artery is patent.The posterior tibial artery is patent.The fourth image is a dsa image of the ankle.The anterior tibial artery is patent.The posterior tibial artery occludes in the upper calf.The distal peroneal artery is patent.The fifth image shows the ¿l¿ fragment now in the lower calf; presumably in the distal peroneal artery.No contrast.The sixth image is a dsa showing the fragment in the distal peroneal artery in the lower calf.There is contrast within a diminutive distal peroneal artery.The anterior tibial artery is patent.Conclusion: this complaint involves a patient undergoing endovascular treatment of a chronic distal sfa occlusion.While utilizing an outback reentry device the distal ¿l¿ marker fractured and was dislodged in the distal tibioperoneal artery.During attempted retrieval, the fragment embolized distally into the distal peroneal artery and was unable to be retrieved.Full evaluation of this complaint is limited due to the paucity of clinical information and images provided.I have little information regarding the difficulty of navigating across the segmental sfa occlusion.In light of the information limitation there are two possibilities to explain this event.First, multiple passes within a difficult stenosis could have produced significant stress on the reentry device resulting in fracture.Second, a manufacturing defect could have resulted in device fracture.Bench top evaluation of the device would be very useful in this case if available.This event resulted in thrombosis of the peroneal artery.Although the patient did not experience immediate clinical impact from this even the long-term consequence is unclear.The anterior tibial artery is the dominant vessel and was widely patent at the end of the procedure.¿ one non-sterile outback unit was received for analysis.During visual inspection, the marker band was not attached to the distal housing nosecone assembly, and the marker band was not returned for evaluation.No other anomalies were observed during the analysis.Due the separated condition on the unit received, results showed that the separated area of the marker band/ distal housing and nosecone assembly of the outback unit presented evidence of transferred material.No other anomalies were observed.The transferred material and the welding points that could be observed are evidence that the marker band was attached to the distal housing and nosecone assembly.The exact cause of the separation could not be determined; however, a pulling/stretching event could be related.No other anomalies were observed during the sem analysis.A product history record (phr) review of lot 17947218 revealed no anomalies or non-conformances during the manufacturing and inspection processes that can be associated with the reported event.The reported ¿marker band dislodged in patient¿ was confirmed due to analysis of the returned device and procedural images received.However, the exact cause of the issue experienced by the customer could not be determined.Based on the information available for review and the product analysis, it is likely that excessive force was applied to the device (such as pulling/stretching) which resulted in the separation of the distal tip/markerband, as evidenced by the material transfer and welding points noted at the section of distal tip separation during the sem analysis.According to the instructions for use, which is not intended as a mitigation, it cautions to ¿not use without completely reading and understanding this document.The outback elite re-entry catheter should be kept straight during flushing, preparation steps and during guidewire loading.A sterile gauze sponge with heparinized saline may be used to wipe the catheter (with the cannula in the retracted position) going from the proximal hub to the distal tip.Do not tug or otherwise overstretch the catheter to straighten it.Always confirm visualization of the targeted distal vessel via contrast injection and fluoroscopy before using the catheter.Avoid contrast injection in the sub-intimal space.Always visualize tracking of the catheter tip over the aorto-iliac bifurcation.If strong resistance is felt during catheter manipulation/delivery, determine the cause of the resistance before proceeding further.Consider using a 3¿4 mm balloon at low atm to dilate points of resistance, as needed, along delivery track.If the cause cannot be determined, withdraw the outback elite re-entry catheter.Excessive rotation, bending or kinking of the outback elite re-entry catheter may affect its performance.Withdraw the outback elite re entry catheter if it becomes excessively kinked.¿ also, the instructions during prep of the device states, ¿ensure proper function of the outback elite re-entry catheter by 1) retracting and advancing the cannula tip via proximal and distal movement of the deployment slide, and 2) rotating the rotating knob which rotates the catheter shaft/nosecone.¿ neither the product analysis nor the phr review suggests that the failures experienced by the customer could be related to the manufacturing process of the unit.Therefore, no corrective/preventative actions will be taken at this time.

• Brand Name: OUTBACK
• Type of Device: CATHETER FOR CROSSING TOTAL OCCLUSIONS
• Manufacturer (Section D): CORDIS CORPORATION; 14201 nw 60 avenue; miami lakes FL 33014
• Manufacturer (Section G): CORDIS CORPORATION; 14201 nw 60 avenue; miami lakes FL 33014
• Manufacturer Contact: karla castro ; 14201 nw 60 avenue; miami lakes, FL 33014 ; 7863138372
• MDR Report Key: 14349413
• MDR Text Key: 291326916
• Report Number: 9616099-2022-05618
• Device Sequence Number: 1
• Product Code: PDU
• UDI-Device Identifier: 20705032035016
• UDI-Public: (01)20705032035016(17)220430(10)17947218
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: K043534
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 07/28/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/10/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 04/30/2022
• Device Model Number: OTB42120
• Device Catalogue Number: OTB42120
• Device Lot Number: 17947218
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 07/11/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/25/2020
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: UNK.
• Patient Outcome(s): Other