MAUDE Adverse Event Report: MEDTRONIC IRELAND ATTAIN SELECT II; CATHETER, PERCUTANEOUS

Model Number	6248V-90S
Medical Device Problem Codes	Break (1069); Detachment Of Device Component (1104); Material Fragmentation (1261); Device Or Device Fragments Location Unknown (2590)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	07/26/2017
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during the implant procedure when the physician started to slit the catheter, the hub and part of the proximal catheter totally separated and detached from the remaining body of the catheter.The physician was required to cut away the remaining catheter with iris scissors.No patient complications have been reported as a result of this event.
Additional Manufacturer Narrative
Product event summary: the delivery catheter was returned and analyzed.The mechanical operation of the catheter peeling/slitting/splitting showed a spiral slit.The mechanical operation of the catheter was damaged.Visual analysis of the lead indicated damage during use.The analyst noted that the slitter was not returned, therefore brand and condition are unknown.Stress cracking (due to spiral slitting) was visible on shaft; shaft separated at 1.3cm from handle.Only a partial catheter was returned.If information is provided in the future, a supplemental report will be issued.

• Brand Name: ATTAIN SELECT II
• Common Device Name: CATHETER, PERCUTANEOUS
• Manufacturer (Section D): MEDTRONIC IRELAND; parkmore business park west; galway
• MDR Report Key: 6920978
• Report Number: 9612164-2017-01384
• Device Sequence Number: 13626210
• Product Code: DQY
• UDI-Device Identifier: 00643169143197
• UDI-Public: 00643169143197
• Combination Product (Y/N): N
• Initial Reporter State: MO
• Initial Reporter Country: US
• PMA/510(K) Number: K123153
• 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
• Report Date (Section B): 02/08/2018

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: 06/09/2019
• Device Model Number: 6248V-90S
• Device Catalogue Number: 6248V-90S
• Device Lot Number: 0008669321
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/07/2017
• Initial Date Received by Manufacturer: 07/26/2017
• Supplement Date Received by Manufacturer: 11/07/2017
• Initial Report FDA Received Date: 10/06/2017
• Supplement Report FDA Received Date: 02/08/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 62 YR