MAUDE Adverse Event Report: MEDTRONIC, INC. ATTAIN VENOGRAM BALLOON CATHETER; CATHETER, FLOW DIRECTED

Model Number	6215
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Edema (1820); Vascular Dissection (3160)
Date of Event	11/24/2016
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that during the implant procedure, a vascular dissection occurred while implanting the delivery catheter, which caused vessel edema and difficulty to implant the left ventricular (lv) lead.The delivery catheter was replaced and after the lv lead reached the target position, the lead dislodged during slitting of the delivery catheter.The physician replaced the delivery catheter again to re-implant the lv lead, but the lead dislodged again.It was noted due to patient's vascular dissection and poor cardiac function, the lv lead would not be implanted; the physician chose to implant a single chamber implantable cardioverter defibrillator (icd).No further patient complications have been reported as a result of this event.
Additional Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.

• Brand Name: ATTAIN VENOGRAM BALLOON CATHETER
• Common Device Name: CATHETER, FLOW DIRECTED
• Manufacturer (Section D): MEDTRONIC, INC.; 8200 coral sea street ne; mounds view MN 55112
• MDR Report Key: 6317235
• Report Number: 2182208-2017-00109
• Device Sequence Number: 532945
• Product Code: DYG
• UDI-Device Identifier: 00613994842114
• UDI-Public: 00613994842114
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K012225
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 11/24/2016

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: 01/04/2018
• Device Model Number: 6215
• Device Catalogue Number: 6215
• Device Lot Number: 61464377
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 11/24/2016
• Supplement Date Received by Manufacturer: 11/24/2016
• Initial Report FDA Received Date: 02/09/2017
• Supplement Report FDA Received Date: 09/27/2017
• 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: Life Threatening
• Patient Age: 43 YR