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

Model Number	6250V-EH
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Vascular Dissection (3160)
Date of Event	06/10/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
It was reported by the patient¿s spouse that the patient went into surgery to for a generator upgrade and the surgery took twice as long as expected.The patient¿s spouse was told that they were unable to do three wires as the patient¿s vein was damaged, and therefore only did two wires.The patient¿s spouse also stated that they were told from the surgeon that the cat (chloramphenicol acetyl transferase) scan showed that it was not as bad as they thought and the patient would be okay.Follow-up information was obtained and it was reported that the physician was unable to cannulate the cs (coronary sinus).The physician was unable to pass the guidewire wire into the ivc (inferior vena cava) and could not advance the sheath.After multiple attempts to pass, contrast was injected to determine why.It was found to be a possible small dissection of the svc (superior vena cava).The case was then downgraded from a cardiac resynchronization therapy defibrillator (crt-d) to a dual chamber implantable cardioverter defibrillator (icd).An echo was performed in the lab and no pericardial effusion was detected.No further 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: 8758182
• Report Number: 9612164-2019-02676
• Device Sequence Number: 11393823
• Product Code: DQY
• UDI-Device Identifier: 00643169142886
• UDI-Public: 00643169142886
• Combination Product (Y/N): N
• Initial Reporter State: WV
• 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: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 07/03/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Expiration Date: 02/25/2020
• Device Model Number: 6250V-EH
• Device Catalogue Number: 6250V-EH
• Device Lot Number: 0009297694
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/10/2019
• Initial Report FDA Received Date: 07/03/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Age: 82 YR