MAUDE Adverse Event Report: MEDTRONIC IRELAND ATTAIN PREVAIL DEFLECTABLE CATHETER DELIVERY SYSTEM; CATHETER, PERCUTANEOUS

Model Number	6227DEF04
Medical Device Problem Codes	Defective Device (2588); Material Integrity Problem (2978)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	02/17/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A good faith effort will be made to obtain the applicable information relevant to the report.If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
It was reported that during the implant procedure the physician had resistance advancing the dilator and the catheter over the guidewire; it was very tight in the clavicle area.Upon rethreading the guidewire into the dilator, the catheter did not fit as snugly around the dilator.Also, the physician had trouble slitting the catheter.Near the tip of the catheter, the slitter caught on the wire.No patient complications have been reported as a result of this event.
Additional Manufacturer Narrative
The delivery catheter was returned and analyzed, the mechanical operation of the catheter peeling/slitting/splitting showed a spiral slit.The manipulator wire pulled through the lumen wall.The mechanical operation of the catheter shaft was kinked.A visual summary analysis of the catheter indicated damage during use at the procedure.A good faith effort will be made to obtain the applicable information relevant to the report.If information is provided in the future, a supplemental report will be issued.
Additional Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.

• Brand Name: ATTAIN PREVAIL DEFLECTABLE CATHETER DELIVERY SYSTEM
• Common Device Name: CATHETER, PERCUTANEOUS
• Manufacturer (Section D): MEDTRONIC IRELAND; parkmore business park west; galway
• MDR Report Key: 6466727
• Report Number: 9612164-2017-00387
• Device Sequence Number: 591249
• Product Code: DQY
• UDI-Device Identifier: 00613994450753
• UDI-Public: 00613994450753
• Combination Product (Y/N): N
• Initial Reporter State: TN
• Initial Reporter Country: US
• PMA/510(K) Number: K061480
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 02/17/2017

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: 06/16/2018
• Device Model Number: 6227DEF04
• Device Catalogue Number: 6227DEF04
• Device Lot Number: 0008103435
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/27/2017
• Initial Date Received by Manufacturer: 02/17/2017
• Supplement Date Received by Manufacturer: Not provided; 04/11/2017
• Initial Report FDA Received Date: 04/06/2017
• Supplement Report FDA Received Date: 06/08/2017; 10/02/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 75 YR