MAUDE Adverse Event Report: ST. JUDE MEDICAL, INC.(CRM-SUNNYVALE) CPS DIRECT PL; CATHETER

Model Number	410212
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Heart Failure (2206)
Date of Event	10/13/2018
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
It was reported that the patient presented for an implant procedure.During procedure, atrial and ventricular leads were successfully implanted.While implanting the pacemaker the coronal sinus was unable to be found and the patient developed severe heart failure which obstructed the surgical procedure.The patient was then sent to cardiac care unit (ccu) for treatment.There is no allegation of malfunction from the health care professional that its related to device, sheath or leads.The patient was implanted selectively and discharged.
Additional Manufacturer Narrative
Pma number is included in follow up report which was missed in initial report.
Additional Manufacturer Narrative
A fully split catheter was returned for analysis.The damage found was sustained during the surgical procedure.

• Brand Name: CPS DIRECT PL
• Common Device Name: CATHETER
• Manufacturer (Section D): ST. JUDE MEDICAL, INC.(CRM-SUNNYVALE); 645 almanor avenue; sunnyvale CA 94085
• MDR Report Key: 7993970
• Report Number: 2938836-2018-11627
• Device Sequence Number: 19108702
• Product Code: DQY
• UDI-Device Identifier: 05414734207072
• UDI-Public: 05414734207072
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K061710
• 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,Followup,Followup
• Report Date (Section B): 12/04/2018

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: 02/28/2021
• Device Model Number: 410212
• Device Lot Number: 6382558
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/05/2018
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 10/23/2018
• Supplement Date Received by Manufacturer: 10/23/2018; 11/26/2018
• Initial Report FDA Received Date: 10/23/2018
• Supplement Report FDA Received Date: 10/23/2018; 12/04/2018
• 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: (B)(4); (B)(4); (B)(4)
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Age: 58 YR
• Patient Weight: 60