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

Model Number	6250V-MP
Medical Device Problem Code	Material Integrity Problem (2978)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	01/12/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Product event summary : the partial delivery catheter was returned and analyzed.Analysis indicated that the mechanical operation of the catheter peeling/slitting/splitting showed a spiral slit.Visual analysis of the lead indicated damage during use.The analyst noted that the catheter was returned without the dilator.Visual inspection found there was severe damaged.It appeared an improper slitting on the hub, and there was several spiral slitting on the shaft, damage during the procedure.If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
It was reported that during an implant procedure of the left ventricular lead, the hub of the catheter could not be slit.Two slitters were attempted and then scissors were used.It was noted the lead did not dislodge.No patient complications have been reported as a result of this event.

• Brand Name: ATTAIN COMMAND
• Common Device Name: CATHETER, PERCUTANEOUS
• Manufacturer (Section D): MEDTRONIC IRELAND; parkmore business park west; galway
• MDR Report Key: 7415749
• Report Number: 9612164-2018-00716
• Device Sequence Number: 1482385
• Product Code: DQY
• UDI-Device Identifier: 00643169142893
• UDI-Public: 00643169142893
• Combination Product (Y/N): N
• Initial Reporter State: FL
• 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
• Report Date (Section B): 04/10/2018

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: 06/11/2019
• Device Model Number: 6250V-MP
• Device Catalogue Number: 6250V-MP
• Device Lot Number: 0008916663
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/17/2018
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/12/2018
• Initial Report FDA Received Date: 04/10/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 78 YR
• Patient Weight: 129