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	Pain (1994); Great Vessel Perforation (2152); Cardiac Tamponade (2226); Pericardial Effusion (3271)
Date of Event	11/24/2017
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 that during the implant procedure, a pericardial effusion occurred while utilizing the balloon catheter, along with note of a perforation and tamponade from the perforation.The effusion was noticed by the distribution of contrast fluid on the fluoroscopic imaging.The patient had symptoms of pain, although sedated and then oxygen saturation started to drop.The catheter did not show any visible signs of a defect.The physician did not advance the balloon catheter but rather had the catheter pulled backwards a little in order to have the balloon before inflating it.The coronary sinus of the patient had relatively small diameter.There were no handling errors and no indication the performance of the catheter led to the effusion.The delivery catheter was removed and the patient was transferred to the intensive care unit (icu) due to the effusion.No further patient complications have been reported as a result of this event.

• 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: 7253611
• Report Number: 2182208-2018-00049
• Device Sequence Number: 13480396
• Product Code: DYG
• UDI-Device Identifier: 00613994842114
• UDI-Public: 00613994842114
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• 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: Health Professional
• Type of Report: Initial
• Report Date (Section B): 02/08/2018

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: 04/17/2019
• Device Model Number: 6215
• Device Catalogue Number: 6215
• Device Lot Number: 0061556167
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/24/2017
• Initial Report FDA Received Date: 02/08/2018
• 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: Hospitalization; Life Threatening; Required Intervention
• Patient Age: 65 YR