MAUDE Adverse Event Report: MEDTRONIC IRELAND ATTAIN PREVAIL DEFLECTABLE CATHETER DELIVERY SYSTEM; CATHETER, PERCUTANEOUS

Model Number	6227DEF04
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Perforation (2001)
Date of Event	04/22/2021
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, the physician was attempting to cannulate the coronary sinus, the guide wire from the catheter set was inserted and the guide wire took a path that appeared to be through the coronary sinus.The physician thought the path did not look correct but tracked the guide catheter over the guide wire.A balloon catheter was inserted to the end of the guide catheter and contrast was injected.At this point, it was noted that the contrast was in the pericardial space.The physician removed the balloon catheter and pulled back the guide catheter.The guide wire was then re-inserted into the guide catheter and the coronary sinus was cannulated.The procedure proceeded without incident and was successfully completed.An echo cardiogram was performed post-op and there was no effusion noted.It was further reported that the patient was asymptomatic throughout the procedure and no further action was taken.No further patient complications have been reported as a result of this event.

• Brand Name: ATTAIN PREVAIL DEFLECTABLE CATHETER DELIVERY SYSTEM
• Common Device Name: CATHETER, PERCUTANEOUS
• Manufacturer (Section D): MEDTRONIC IRELAND; parkmore business park west; galway ; EI
• MDR Report Key: 11732359
• Report Number: 9612164-2021-01674
• Device Sequence Number: 4219886
• Product Code: DQY
• UDI-Device Identifier: 00613994450753
• UDI-Public: 00613994450753
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: K061480
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 04/27/2021

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: 09/10/2022
• Device Model Number: 6227DEF04
• Device Catalogue Number: 6227DEF04
• Device Lot Number: 0010373126
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/22/2021
• Initial Report FDA Received Date: 04/27/2021
• 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