MAUDE Adverse Event Report: ST. JUDE MEDICAL, INC.(CRM-SUNNYVALE) CPS DIRECT UNIVERSAL SLITTABLE OUTER CATHETER

Model Number DS2C018

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Death (1802); Ventricular Tachycardia (2132)

Event Date 01/28/2016

Event Type  Death  

Manufacturer Narrative

(b)(4).

Event Description

It was reported that during a device upgrade procedure upon coronary sinus cannulation (cs), the patient's condition had deteriorated.The patient had ventricular tachycardia (vt) and then arrest.The lead was used for pacing but the pacing could not be captured.The pulse returned 5 minutes later, and patient left the operating room (or) with percutaneous cardiopulmonary support (pcps) and intra-aortic balloon pumping (iabp).The patient expired the next day.No further information is available.

Manufacturer Narrative

(b)(4).

Event Description

New information received notes that the patient had an underlying disease of muscular dystrophy.The cause of death was heart failure.

• Brand Name: CPS DIRECT UNIVERSAL SLITTABLE OUTER CATHETER
• Type of Device: CATHETER
• Manufacturer (Section D): ST. JUDE MEDICAL, INC.(CRM-SUNNYVALE); 15900 valley view court; sylmar CA 91342
• Manufacturer (Section G): ST. JUDE MEDICAL, INC.(CRM-SUNNYVALE); 15900 valley view court; sylmar CA 91342
• Manufacturer Contact: jaime chavez ; 645 almanor avenue; sunnyvale, CA 94085 ; 8184934022
• MDR Report Key: 5456793
• MDR Text Key: 38887447
• Report Number: 2938836-2016-01351
• Device Sequence Number: 1
• Product Code: DQY
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K130257
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 01/28/2016

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
• Device Operator: Health Professional
• Device Expiration Date: 03/31/2018
• Device Model Number: DS2C018
• Device Lot Number: 5037865
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 01/28/2016
• Initial Date FDA Received: 02/24/2016
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 03/07/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/02/2015
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Death