MAUDE Adverse Event Report: CORDIS CORPORATION OUTBACK ELITE 80CM RE-ENTRY; CATHETER FOR CROSSING TOTAL OCCLUSIONS

Model Number	OTB59080A
Medical Device Problem Code	Retraction Problem (1536)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	04/25/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Device history record (dhr) review was conducted and the product met quality requirements for product acceptance.This device is available for analysis but has not yet been received.  additional information is pending and will be submitted within 30 days upon receipt.
Event or Problem Description
Before used on the patient, it was reported that the outback elite 80cm re-entry was faulty.Additional information was received and the needle deployed but would not retract back.There was no patient injury.The product was flushed correctly.Once flushed, the needle would not retract again so the device was not used in the patient.This is the first time this has happened in this centre.No other information was provided.
Additional Manufacturer Narrative
It was reported that before use on the patient, the outback elite 80cm re-entry was faulty.Additional information was received and the needle deployed but would not retract back.There was no patient injury.The product was flushed correctly.Once flushed, the needle would not retract again so the device was not used in the patient.This is the first time this has happened in this center.No other information was provided.One non-sterile outback elite 80cm re-entry was received coiled inside a plastic bag.The cannula was received fully deployed.The catheter measured 80.3 cm length.Needle cannula deployment measured 8mm length.The length of the catheter was within specification.No other anomalies were noted in the device.Functional analysis was performed.The cannula was retracted and advanced several times via distal movement of the deployment slider.The device performed properly according to specification.A review of the manufacturing documentation associated with lot 17301452 was performed and it was found that 1 defective unit was rejected during the assembly of this lot.  the ¿cannula/needle (outback only) - retraction difficulty-unable to¿ reported by the customer was not confirmed as the cannula was successfully retracted and advanced several times.The exact cause of the reported condition could not be conclusively determined.The product instructions for use (ifu) cautions the user that excessive calcification at the site of re-entry may impair the device¿s performance.It instructs the user to retract the cannula tip into the device by fully retracting the handle deployment slide until it stops.The user is then to release the handle deployment slide button to lock the deployment slide in the retracted position.The user is then instructed to ensure that the cannula tip is fully retracted into the catheter lateral port and the handle deployment slide is locked, prior to withdrawing the catheter over the guidewire.Neither the product analysis nor the manufacturing records review suggests that the event experienced by the customer could be related to the manufacturing process.Therefore, no corrective or preventive actions will be taken at this time.

• Brand Name: OUTBACK ELITE 80CM RE-ENTRY
• Common Device Name: CATHETER FOR CROSSING TOTAL OCCLUSIONS
• Manufacturer (Section D): CORDIS CORPORATION; 14201 nw 60th ave; miami lakes FL 33014
• MDR Report Key: 6594050
• Report Number: 9616099-2017-01126
• Device Sequence Number: 1123228
• Product Code: PDU
• UDI-Device Identifier: 20705032067567
• UDI-Public: 20705032067567
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• PMA/510(K) Number: K150836
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Health Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 06/21/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 07/31/2017
• Device Model Number: OTB59080A
• Device Catalogue Number: OTB59080A
• Device Lot Number: 17301452
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/01/2017
• Distributor Facility Aware Date: 05/03/2017
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 05/03/2017
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 05/26/2017
• Supplement Report FDA Received Date: 06/21/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1