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

Model Number	6248V-130
Medical Device Problem Codes	Material Fragmentation (1261); Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	07/23/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
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 catheter broke a couple of inches past the hub during slitting after the lead was placed.The catheter was removed.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.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: 8879942
• Report Number: 9612164-2019-03313
• Device Sequence Number: 16197172
• Product Code: DQY
• UDI-Device Identifier: 00643169143203
• UDI-Public: 00643169143203
• Combination Product (Y/N): N
• Initial Reporter State: OH
• 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): 08/29/2019

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: 05/06/2021
• Device Model Number: 6248V-130
• Device Catalogue Number: 6248V-130
• Device Lot Number: 0009728323
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/15/2019
• Initial Date Received by Manufacturer: 07/23/2019
• Supplement Date Received by Manufacturer: 08/28/2019
• Initial Report FDA Received Date: 08/09/2019
• Supplement Report FDA Received Date: 08/29/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 76 YR