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

Model Number	6248V-90
Medical Device Problem Codes	Accessory Incompatible (1004); Break (1069)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	01/15/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Concomitant medical products: etlw1616c124e stent graft, implanted: (b)(6) 2017; etlw1613c124e stent graft, implanted: (b)(6) 2017; esbf2514c103e stent graft, implanted: (b)(6) 2017.If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
It was reported that during the implant attempt, when the physician was slitting the sheath, the slitter disengaged from the delivery sheath and could not be easily reengaged.Repeated attempts to reengage the slitter resulted in the catheter "breaking".A cut had to be made with an iris scissors in the catheter to provide entry for the slitter blade.The physician was then able to continue slitting, but with difficulty.The sheath was eventually slit, but in the process the left ventricular lead dislodged and was trapped inside the catheter.The catheter and lead were removed.The decision was made to abandon the lead as possible damage to the lead during the slitting process could not be ruled out.A new lead was subsequently implanted.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 slitting showed a spiral slit.The shaft of the catheter was damaged, broken at 10.5 cm.Visual analysis of the catheter indicated damage during use.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: 8320930
• Report Number: 9612164-2019-00461
• Device Sequence Number: 1527029
• Product Code: DQY
• UDI-Device Identifier: 00643169143210
• UDI-Public: 00643169143210
• Combination Product (Y/N): N
• Initial Reporter State: MA
• Initial Reporter Country: US
• PMA/510(K) Number: K123153
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Device Explanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 03/03/2019

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: 08/30/2020
• Device Model Number: 6248V-90
• Device Catalogue Number: 6248V-90
• Device Lot Number: 0009306386
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/22/2019
• Initial Date Received by Manufacturer: 01/15/2019
• Supplement Date Received by Manufacturer: 03/01/2019
• Initial Report FDA Received Date: 02/08/2019
• Supplement Report FDA Received Date: 03/03/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: 5086MRI45 LEAD, 5086MRI58 LEAD
• Patient Age: 77 YR
• Patient Weight: 90