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

Catalog Number OTB59120A

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

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 06/08/2015

Event Type  malfunction  

Manufacturer Narrative

Concomitant medications: non-cordis 6f and 7f sheaths.Complaint conclusion: while advancing the outback through a 6f non-cordis sheath the outback would not cross the bifurcation.It was removed and re-prepped as before.The 6fr.Sheath was removed and a non-cordis 7f sheath was inserted.The outback was re-inserted and crossed the bifurcation.It continued over the wire to the distal calcified left superficial femoral artery where re-entry into the true lumen past the lesion was attempted.However, it was noted that the needle would not fully extend.The slider was moving properly but the cannula was not responding to the slider movement.The physician removed the outback and attempted to move the cannula again while on the sterile back table, and the cannula moved only 1 or 2 mm while the slider appeared to move as expected (the entire length).The procedure then concluded without using another device and there were no reported patient injury.The outback was opened and prepped in a sterile manner per ifu.The ports were flushed, followed by a 30 second delay, and then flushed again.The cannula/slider appeared to be functioning normally, and there was no hesitation to use the device.A contralateral approach was made from the right common femoral artery.There was no kink on the guidewire.The vessels were very tortuous and calcified, making the advancement of the device difficulty.One non sterile outback was received coiled in two plastic bags.The cannula was retracted; there was a severe kink approx.2 cm proximal of the side hole.No other anomalies were observed.The unit was reviewed under microscope and it was observed that close to the kink area, the shaft showed a gray section, showing a stress/elongated area on the surface.Functional analysis was performed.There was a slight resistance on the actuator while trying to deploy the cannula.The extension of the cannula when the actuator was at the max extension position was about 5mm.The complaint unit was compared against a random unit taken from production: the outer shaft length from both units was measured (between distal tip of housing and distal edge of strain relief) and the results were: customer complaint unit was 120.2 cm against random unit taken from production that was 119.7 cm.The handle halves of both units were opened to expose the internal components.There were no issues observed on the molded components from both units.It was measured the position of dumbbell on inner key, and compared to production device: complaint unit was 6.6 cm.The sample unit from the production line was 6.8 cm.The failure reported by the customer as ¿cannula/needle (outback only) - deployment difficulty-incomplete¿ was confirmed since during functional analysis, the extension of the cannula when the actuator was at the max extension position was about 5mm.The cause of this anomaly was related to the damage observed on the distal section of the outer shaft (kink and stressed conditions) as well as the accumulation of dried blood residuals in the outer shaft.The exact cause of these damages could not be conclusively determined; however, as per product analysis and event description information, procedural factors might have impacted the reported event as well as the nonconformities observed during the analysis.In addition, controls are placed in the manufacturing line to prevent defective units from leaving the building.Neither the analysis nor the dhr review suggests that this event is related to the manufacturing process; therefore no action was taken.The failure reported by the customer as ¿cannula/needle (outback only) - deployment difficulty-incomplete¿ was confirmed during analysis which was likely due to the stretched condition of the shaft which was noted as an additional defect during analysis.There was no information provided by the user to explain how the shaft might have become stretched, such as a withdrawal difficulty.With the limited amount of information available it is not possible to draw a clinical conclusion between the device and the event.

Event Description

During the use of an outback device it was reported that the device was attempted through a 6f non-cordis sheath but would not cross the bifurcation.It was removed and re-prepped as before.A non-cordis 7f sheath was then placed into the patient and the outback was re-inserted and this time it crossed the bifurcation.It continued over the wire to the distal calcified left superficial femoral artery where it was attempted to re-enter the true lumen.They were successful at advancing to the destination, however, when attempting to re-enter noted the needle would not extend fully.In this case, the slider was moving, but the cannula was not responding to the slider movement.The physician removed the outback and attempted to move the cannula again while on the sterile back table, and the cannula itself moved only 1 or 2 mm while the slider appeared to move as expected (the entire length).The procedure then concluded without using another device and there were no patient injuries.The outback was opened and prepped in a sterile manner per ifu.The ports were flushed, followed by a 30 second delay, and then flushed again.The cannula/slider appeared to be functioning normally, and there was no hesitation to use the device.A contralateral approach was made from the right common femoral artery.There was no kink on the guidewire.It was noted that the vessels were very tortuous and calcified, making the advancement of the device difficulty.The device will be returned for analysis.Per the failure analysis, the unit was reviewed under microscope and it was observed that close to the kink area, the shaft showed a gray section, showing a stress/elongated area on the surface.

• Brand Name: OUTBACK ELITE RE-ENTRY CATHETER
• Type of Device: CATHETER FOR CROSSING TOTAL OCCLUSIONS
• Manufacturer (Section D): CORDIS CORPORATION; 14201 nw 60th avenue; miami lakes FL
• Manufacturer Contact: cecil navajas ; 14201 nw 60th avenue; miami lakes, FL 33014 ; 7863133880
• MDR Report Key: 4976710
• MDR Text Key: 22388469
• Report Number: 1016427-2015-00041
• Device Sequence Number: 1
• Product Code: PDU
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K150836
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional
• Reporter Occupation: Health Professional
• Type of Report: Initial
• Report Date: 08/04/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/06/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 03/31/2017
• Device Catalogue Number: OTB59120A
• Device Lot Number: 17234992
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/24/2015
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/04/2015
• Date Device Manufactured: 05/14/2015
• Is the Device Single Use?: Yes
• Patient Sequence Number: 1