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

Model Number	6225
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	12/26/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
It was reported that the coronary sinus appeared with dye staining after a balloon catheter was used with dye injection.The catheter was removed.No patient complications have been reported as a result of this event.

• Brand Name: ATTAIN CLARITY
• Common Device Name: CATHETER, PERCUTANEOUS
• Manufacturer (Section D): MEDTRONIC IRELAND; parkmore business park west; galway
• MDR Report Key: 9588295
• Report Number: 9612164-2020-00223
• Device Sequence Number: 11557253
• Product Code: DQY
• UDI-Device Identifier: 00643169530102
• UDI-Public: 00643169530102
• Combination Product (Y/N): N
• Initial Reporter State: WV
• Initial Reporter Country: US
• PMA/510(K) Number: K121219
• 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): 01/14/2020

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: 09/24/2020
• Device Model Number: 6225
• Device Catalogue Number: 6225
• Device Lot Number: 0009335563
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/26/2019
• Initial Report FDA Received Date: 01/14/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 66 YR