MAUDE Adverse Event Report: CORDIS CORPORATION OUTBACK ELITE 120CM RE-ENTRY; CATHETER FOR CROSSING TOTAL OCCLUSIONS

Model Number OTB59120A

Device Problems Fracture (1260); Stretched (1601); Unraveled Material (1664)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 01/15/2018

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.A device history record (dhr) review of lot 17660061 revealed no anomalies or non-conformances during the manufacturing and inspection processes that can be associated with the reported event.

Event Description

As reported, the physician proceeded with the outback elite (120cm re-entry) to re-enter the lumen of the sfa with outback after going-sub-intimal.The physician deployed the needle and re-entered the lumen with a non-cordis guidewire.Then, the physician had issues pulling the outback device out of the patient on the guidewire.The physician was able to do so but the outback device was stretched out and broken at the distal end.The physician was however able to keep the guidewire in place and there was no adverse event for the patient.The physician was then able to complete the procedure without any issues.The product was clinically used and will be returned for analysis.Vessel characteristics at the access site was normal.The target site was calcified, had normal tortuosity.The target site was treated for chronic total occlusion (cto.) a contralateral approach was used.There was no damage to the outback device noticed prior to opening the package.All the specified ports of the device were properly flushed.The ports were flushed, followed by a 30 second delay, and then flushed again.Cannula action was verified during prep.A non-cordis.014 guidewire was used.There were no problems noted with the guidewire used.The device was straight prior to loading.The needle/cannula fully retracted prior to insertion of the wire.The cannula actuated smoothly.Some resistance was met while advancing the device over the guidewire but nothing out of the ordinary.The device did not kink nor bend at any time prior to the resistance/friction.According to the operator, the guidewire may have been lightly kinked after re-entry into the lumen.The product, or any of the other devices used with it, had not been resterilized.There was no difficulty tracking through the vasculature.The device was removed intact (in one piece) from the patient.The operator managed to pull the outback out of the patient in one piece while maintaining the re-access point with the gw.He then proceeded to do the angioplasty with an acceptable end result.

Manufacturer Narrative

Complaint conclusion: as reported, the physician proceeded with the outback elite (120cm re-entry) to re-enter the lumen of the superficial femoral artery (sfa) with outback after going sub-intimal.The physician deployed the needle and re-entered the lumen with a command guidewire.Then, the physician had issues pulling the outback device out of the patient on the command guidewire.The physician was able to do so but the outback device was stretched out and broken at the distal end.The physician was however able to keep the guidewire in place and there was no adverse event for the patient.The physician was then able to complete the procedure without any issues.Vessel characteristics at the access site was normal.The target site was calcified and had normal tortuosity.The target site was treated for chronic total occlusion (cto).A contralateral approach was used.There was no damage to the outback device noticed prior to opening the package.All the specified ports of the device were properly flushed.The ports were flushed, followed by a 30 second delay, and then flushed again.Cannula action was verified during prep.A non-cordis.014 guidewire was used.There were no problems noted with the guidewire used.The device was straight prior to loading.The needle/cannula fully retracted prior to insertion of the wire.The cannula actuated smoothly.Some resistance was met while advancing the device over the guidewire but nothing out of the ordinary.The device did not kink nor bend at any time prior to the resistance/friction.According to the operator, the guidewire may have been lightly kinked after re-entry into the lumen.The product, or any of the other devices used with it, had not been resterilized.There was no difficulty tracking through the vasculature.The device was removed intact (in one piece) from the patient.The operator managed to pull the outback out of the patient in one piece while maintaining the re-access point with the guidewire.The operator then proceeded to do the angioplasty with an acceptable end result.Non-sterile units of outback elite 120cm re-entry were received coiled and protected by a bubbled packaging material inside of a clear plastic bag.Device was unpacked to be visually inspected.An unraveled/stretched condition was observed at the body shaft.Dried blood saturation was observed at the device.The insertion/withdrawal test could not carry out due to the unraveled/stretched condition in which the part was received.The unraveled/stretched condition observed at the body shaft is located at 2.5 cm from the distal tip, and it has a length of 2 cm.A review of the manufacturing documentation associated with lot 17660061 was performed and it was found that no issues were noted that were considered potentially related to the reported complaint.The event reported by the customer as ¿cannula wire port/guidewire lumen- resistance/friction¿ was not confirmed because the functional insertion/withdrawal test could not be performed due to the unraveled/stretched condition observed during the visual inspection.The event reported by the customer as ¿catheter (body/shaft) - unraveled/ stretched¿ was confirmed.An unraveled/stretched condition was observed at the body shaft.The anomaly is located at 2.5 cm from the distal tip, and it has a length of 2 cm.The event reported by the customer as ¿catheter tip/distal tip- fractured¿ was not confirmed.Distal tip was visually inspected and no damages or anomalies were observed.However, an unraveled/stretched condition was noticed during the visual inspection.The exact cause of reported event could not be conclusive determined.Procedural factors and handling process, may have contributed to the event as reported.According to the product instruction for use, users are cautioned that 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 catheter as was done in this case.Neither the device history record review nor the product analysis suggests that the observed unraveled/stretched condition could be related to the manufacturing process of the unit.Therefore, no corrective or preventive actions will be taken at this time.

• Brand Name: OUTBACK ELITE 120CM RE-ENTRY
• Type of Device: CATHETER FOR CROSSING TOTAL OCCLUSIONS
• Manufacturer (Section D): CORDIS CORPORATION; 14201 nw 60 avenue; miami lakes FL 33014
• MDR Report Key: 7251126
• MDR Text Key: 99799823
• Report Number: 9616099-2018-01833
• Device Sequence Number: 1
• Product Code: PDU
• Combination Product (y/n): N
• PMA/PMN Number: K150836
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Type of Report: Initial,Followup
• Report Date: 03/02/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/08/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 03/31/2019
• Device Model Number: OTB59120A
• Device Catalogue Number: OTB59120A
• Device Lot Number: 17660061
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/05/2018
• Date Manufacturer Received: 02/27/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1