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

Catalog Number OTB42120

Device Problems Fracture (1260); Peeled/Delaminated (1454)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 10/23/2015

Event Type  malfunction  

Manufacturer Narrative

The device was returned for analysis but was not received to date.Additional information received will be submitted within 30 days upon receipt.Please note that this is one of two products associated with the reported event submitted under manufacturing report numbers 9616099-2015-00639 and 9616099-2015-00671.

Event Description

During a procedure to treat a distal sfa occlusion, there was difficulty retracting the needle of an outback catheter and the needle appeared to shear off but remained attached to the device by the inner coils.The device was removed and there was no reported patient injury.Access to the lesion was gained with a 7f terumo destination sheath;.014" journey wire was used to pass device to the proximal popliteal artery; outback device was oriented using fluoroscopy and needle was actuated to facilitate re-entry; physician was unable to pass wire through cannula needle and attempted to retract needle; needle failed to retract, but upon manipulation of the catheter it was discovered that the needle appeared to shear; further manipulation revealed that the needle did not shear off completely; device was pulled back to within the sheath with the cannula partially attached to the device; after removal the device was inspected by staff; inner "coils" were keeping cannula needle attached to the device// a second outback device was used to treat the patient; device was advanced similarly and once again the wire could not pass through the cannula needle after actuation; needle was retracted and at that point the entire distal tip of the catheter appeared to detach from the catheter; once again the inner "coils" enabled the tip to remain partially attached to the device; no further action was taken to treat the patient.The initial report involved one device which was reported to have sheared off but there was no patient injury.

Manufacturer Narrative

Complaint conclusion a report was received that the tip of two outback ltd re-entry catheters were partially sheared off.These devices were both removed intact within the sheath/catheter without further intervention or patient injury.The event involved a 72 year old male patient with a past medical history of peripheral vascular disease with claudication.The target lesion was located in the distal left superficial femoral artery.The patient¿s vasculature was accessed contralaterally with a non-cordis catheter sheath introducer and a non-cordis 0.014¿ guidewire via the right femoral artery.The first outback ltd catheter was advanced to the target lesion and the cannula needle deployed into the true lumen.The physician was then unable to pass the guidewire through the cannula needle and was not able to retract the needle.During these retraction manipulations, the site reported that the needle appeared to shear partway off.The device was pulled back within the sheath with the partially detached needle.Once removed, the site reported that the inner ¿coils¿ of the device were holding the nearly detached needle in place.The device was removed and a second outback ltd introduced.The physician was again unable to pass the guidewire through the deployed cannula needle.He/she was then retracted the cannula and the tip of the needle again partially sheared off.Once removed, the site reported that the inner ¿coils¿ of this second device were holding the nearly detached needle in place.It appears that the procedure was aborted at this point with no reported patient injury.Attempts to obtain further information about this event have been unsuccessful.The product was not returned for evaluation.A review of the manufacturing records could not be conducted without a lot number.Without the return of the devices for analysis, the reported events could not be confirmed and no determination of possible contributing factors could be made.The product ifu instructs the user to always visualize tracking of the catheter tip over the aorto-iliac bifurcation.It furthers 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 contribute to the reported events.Based on the limited information available for review, it is not possible to determine what factors may have contributed to the reported issue.Based on the device history record review (of one of the products), there is no indication that the event was related to the manufacturing process.Therefore, no corrective actions will be taken at this time.Please note that this is one of two products associated with the reported event submitted under manufacturing report numbers 9616099-2015-00639 and 9616099-2015-00671.

• 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: 5326393
• MDR Text Key: 34303829
• Report Number: 9616099-2015-00671
• Device Sequence Number: 1
• Product Code: DQY
• 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: 11/17/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/24/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: OTB42120
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/24/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Age: 72 YR