MAUDE Adverse Event Report: ST. JUDE MEDICAL, INC. CPS DIRECT UNIVERSAL SLITTABLE OUTER CATHETER

Model Number	DS2C018
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Vascular Dissection (3160)
Date of Event	12/04/2018
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 an implant procedure, while placing a straight catheter in the coronary sinus (cs), x-ray was performed and revealed a dissection of the cs.A second attempt to place the straight catheter into the cs was used with a balloon catheter, however, the straight catheter could not be positioned correctly in the cs.The procedure was terminated and the patient remained in the hospital.Following the procedure, an echocardiogram was performed and revealed no pericardial effusion.The patient was stable and asymptomatic.No additional intervention was performed.There was no alleged malfunction against the performance of any abbott device.

• Brand Name: CPS DIRECT UNIVERSAL SLITTABLE OUTER CATHETER
• Common Device Name: CATHETER
• Manufacturer (Section D): ST. JUDE MEDICAL, INC.; 15900 valley view court; sylmar CA 91342
• MDR Report Key: 8289429
• Report Number: 2017865-2019-01403
• Device Sequence Number: 11260496
• Product Code: DQY
• UDI-Device Identifier: 05415067004178
• UDI-Public: 05415067004178
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: K130257
• 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): 01/30/2019

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: 02/27/2021
• Device Model Number: DS2C018
• Device Lot Number: 6353810
• 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: 01/04/2019
• Initial Report FDA Received Date: 01/30/2019
• 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: Hospitalization