MAUDE Adverse Event Report: ST. JUDE MEDICAL, INC.(CRM-SYLMAR) CPS DIRECT SL II (SLITTABLE) OUTER GUIDE CATHETER

Model Number	DS2C002
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Vascular Dissection (3160)
Date of Event	02/21/2019
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
It was reported that during a procedure for a new implant, when attempting to cannulate the coronary sinus for lead placement, the physician inserted the catheter into the vessel, when gliding the sheath over, movement (deep breathing) and force from the sheath contact caused a coronary sinus dissection.The physician believed he may have selected the wrong curve of sheath.The leads were successfully implanted and the patient was monitored throughout.A subsequent echocardiogram post procedure confirmed no effusion was present.The patient was stable with no other complications.

• Brand Name: CPS DIRECT SL II (SLITTABLE) OUTER GUIDE CATHETER
• Common Device Name: CATHETER
• Manufacturer (Section D): ST. JUDE MEDICAL, INC.(CRM-SYLMAR); 15900 valley view court; sylmar CA 91342
• MDR Report Key: 8400688
• Report Number: 2017865-2019-03454
• Device Sequence Number: 1922577
• Product Code: DQY
• UDI-Device Identifier: 05414734218207
• UDI-Public: 05414734218207
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: K092075
• 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): 03/07/2019

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: 03/31/2021
• Device Model Number: DS2C002
• Device Lot Number: 6402173
• 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: 02/21/2019
• Initial Report FDA Received Date: 03/07/2019
• 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: Required Intervention