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

Model Number OTB42120

Device Problem Device Dislodged or Dislocated (2923)

Patient Problem Foreign Body In Patient (2687)

Event Date 10/14/2016

Event Type  Injury  

Manufacturer Narrative

Manufacturing record (dhr) review was conducted and the product met quality requirements for product acceptance per the applicable manufacturing quality plan.The product was returned for evaluation and testing; however, the engineering evaluation is not complete.Additional information will be submitted within 30 days upon receipt.

Event Description

As reported, the t marker band from the outback cto catheter came off in the patient after great difficulty was experienced crossing the iliac arch (the device was damaged when attempting to cross a difficult iliac arch).Additional information received indicated that there was great difficulty crossing the iliac arch.The target lesion was reported to be calcified.The approach was contralateral.The marker band dislodged in the external iliac and then migrated down the profunda.The physician had changed the sheath used from a 6 fr.To a 7 fr.In attempting to cross the iliac arch.The dislodged marker band was left/remained in the patient.There is no further plan for treatment of the patient and the dislodged marker band.The patients current status was said to be fine with no problems reported.Procedural films were said to be possibly available if requested.The physician was finally able to re-enter the vessel without the outback to complete the procedure successfully.There was no damage to the outback device noticed prior to opening the package.All of the specified ports of the device were properly flushed, and followed by a thirty second delay, and then flushed again.The cannula action was verified during prep.Both a.014 stabilizer and.018 sv5 guidewire were used during the procedure.There were no reported problems with the guidewires used.The outback device was straight prior to loading.The guidewire was ultimately loaded successfully.The needle/cannula was fully retracted prior to insertion of the guidewire.The cannula actuated smoothly.The guidewire was not kinked or bent.There was no damage to the guidewire noted when the product was removed (i.E.Sheared, frayed).The guidewire was not used previously in the procedure.The physician and technician are considered to be expert users of the device.The physician has performed over fifty cases with the device.The sales rep was not present for the case.

Manufacturer Narrative

As reported, the ¿t¿ marker band from the outback cto catheter came off in the patient after great difficulty was experienced crossing the iliac arch (the device was damaged when attempting to cross a difficult iliac arch).Additional information received indicated that there was great difficulty crossing the iliac arch.The target lesion was reported to be calcified.The approach was contralateral.The marker band dislodged in the external iliac and then migrated down the profunda.The physician had changed the sheath used from a 6 fr.To a 7 fr.In attempting to cross the iliac arch.The dislodged marker band was left/remained in the patient.There is no further plan for treatment of the patient and the dislodged marker band.The patient¿s current status was said to be fine with no problems reported.Procedural films were said to be possibly available if requested.The physician was finally able to re-enter the vessel without the outback to complete the procedure successfully.There was no damage to the outback device noticed prior to opening the package.All of the specified ports of the device were properly flushed, and followed by a thirty (30) second delay, and then flushed again.The cannula action was verified during prep.Both a.014 stabilizer and.018 sv5 guidewire were used during the procedure.There were no reported problems with the guidewires used.The outback device was straight prior to loading.The guidewire was ultimately loaded successfully.The needle/cannula was fully retracted prior to insertion of the guidewire.The cannula actuated smoothly.The guidewire was not kinked or bent.There was no damage to the guidewire noted when the product was removed (i.E.Sheared, frayed).The guidewire was not used previously in the procedure.The physician and technician are considered to be expert users of the device.The physician has performed over fifty (50) cases with the device.The sales rep.Was not present for the case.  one not sterile outback was received coiled inside a plastic bag.The unit was partially separated at 1.5cm from the distal end.The cannula needle was protruding from the shaft.The nosecone was not received.No other anomalies were observed.During microscopic analysis, it was noted that the device was elongated in the sections of the separation.It seems that the unit was stressed at the rupture point until the distal section separated.The presence of the solder marks were observed in the joint of the keyed housing-nosecone, as expected.A review of the manufacturing documentation associated with this lot presented no issues during the manufacturing process that can be related to the reported complaint.  the event reported as ¿cto catheter system - tracking difficulty¿ could not be properly evaluated as no functional analysis could be performed due to the condition in which the unit was received.The event reported as ¿marker band (outback) - dislodged - in-patient¿ was confirmed since the nosecone (w/nosecone lt marker) was not received.The exact cause of the events reported as well as the damaged conditions observed on the distal section of the outback body could not be conclusively determined.However, as per product analysis, procedural/handling factors might have contributed to those failures.The product instructions for use (ifu) instructs the user to always visualize tracking of the tip over the aorto-iliac bifurcation.It further 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.Tracking the outback through an acute vessel angle, such as the aorto-iliac bifurcation, may contribute to the reported events.Neither the product analysis nor the manufacturing records reviews suggest that the events could be related to the manufacturing process.Therefore, no corrective or preventive action will be taken at this time.

• Brand Name: OUTBACK
• Type of Device: CATHETER FOR CROSSING TOTAL OCCLUSIONS
• Manufacturer (Section D): CORDIS DE MEXICO; circuito int nte 1820; juarez 32575 ; MX 32575
• Manufacturer (Section G): CORDIS DE MEXICO; circuito int nte 1820; juarez 32575 ; MX 32575
• Manufacturer Contact: cecil navajas ; 14201 nw 60th ave.; miami lakes, FL 33014
• MDR Report Key: 6096139
• MDR Text Key: 59718328
• Report Number: 9616099-2016-00721
• 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: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 12/15/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/11/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Expiration Date: 09/30/2016
• Device Model Number: OTB42120
• Device Catalogue Number: OTB42120
• Device Lot Number: 17124436
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/21/2016
• Is the Reporter a Health Professional?: Yes
• Distributor Facility Aware Date: 10/17/2016
• Date Manufacturer Received: 12/09/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/26/2014
• 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
• Patient Outcome(s): Life Threatening; Required Intervention