MAUDE Adverse Event Report: ABBOTT CPS DIRECT PL; CATHETER, PERCUTANEOUS

Model Number	410212
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Vascular Dissection (3160)
Date of Event	10/12/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The results of the investigation are inconclusive since the device was not returned for analysis.Based on the information received, the cause of the reported incident could not be conclusively determined.
Event or Problem Description
During the implant procedure of the left ventricular (lv) lead, there were a dissection of the coronary sinus noted.The coronary sinus was cannulated with cps direct pl, and an initial contrast injection did not show signs of dissection.During positioning of the lead with the cps courier guidewire, a new venography was performed, which showed a small dissection of the coronary sinus.In the physician¿s opinion, the dissection was caused by either the cps direct pl, or the cps courier guidewire.The procedure was abandoned, and the lv lead was not implanted.A new lv lead was implanted at a later date, and the dissection had healed.The patient was stable with no consequences.Related manufacturer report number: 2017865-2020-15827.

• Brand Name: CPS DIRECT PL
• Common Device Name: CATHETER, PERCUTANEOUS
• Manufacturer (Section D): ABBOTT; 15900 valley view court; sylmar CA 91342
• MDR Report Key: 10741337
• Report Number: 2017865-2020-15828
• Device Sequence Number: 19679566
• Product Code: DQY
• UDI-Device Identifier: 05414734207072
• UDI-Public: 05414734207072
• Combination Product (Y/N): N
• Initial Reporter Country: IT
• 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
• Report Date (Section B): 10/27/2020

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: 07/31/2023
• Device Model Number: 410212
• Device Lot Number: 7621651
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/12/2020
• Initial Report FDA Received Date: 10/27/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: CPS COURIER GUIDEWIRE
• Outcome Attributed to Adverse Event: Required Intervention