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

Model Number	6225
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Vascular Dissection (3160)
Date of Event	09/14/2017
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that during the implant procedure, the patient experienced a coronary sinus dissection due to the balloon catheter.It was noted the dissection was caused by the balloon traumatizing the endothelium during the left ventricular lead implant, which then proceeded to implant.The patient was a participant in the attain stability quad study.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 CLARITY
• Common Device Name: CATHETER, PERCUTANEOUS
• Manufacturer (Section D): MEDTRONIC IRELAND; parkmore business park west; galway
• MDR Report Key: 7093524
• Report Number: 9612164-2017-01787
• Device Sequence Number: 903523
• Product Code: DQY
• UDI-Device Identifier: 00643169530102
• UDI-Public: 00643169530102
• Combination Product (Y/N): N
• Initial Reporter State: IA
• 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,Followup
• Report Date (Section B): 07/08/2020

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: 06/27/2019
• Device Model Number: 6225
• Device Catalogue Number: 6225
• Device Lot Number: 0008674227
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 09/27/2017
• Supplement Date Received by Manufacturer: 06/19/2020
• Initial Report FDA Received Date: 12/07/2017
• Supplement Report FDA Received Date: 07/08/2020
• 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: 88 YR
• Patient Weight: 77