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

Model Number DS2C003

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

Patient Problems Cardiac Arrest (1762); Death (1802); Low Blood Pressure/ Hypotension (1914); Pain (1994); Ventricular Fibrillation (2130); Loss of consciousness (2418); Pericardial Effusion (3271)

Event Date 03/05/2015

Event Type  Death  

Event Description

It was reported that during a crt-d implant procedure, while the physician was repositioning the catheter the patient complained experiencing back pain.The patient became hypotensive and lost consciousness followed by ventricular fibrillation and asystole.Cardiopulmonary resuscitation was performed for one hour and the patients heart rhythm was then stabilized.The patient remained unconscious and kidney failure was then noted.An echocardiogram image was performed and revealed a pericardial effusion.The patients condition did not improve and remained hospitalized.On (b)(6) 2015 the patient deceased from hypoxic brain damage and acute renal failure.The physician stated that the patients death was not device related.

Manufacturer Narrative

(b)(4).

• Brand Name: CPS DIRECT SL II (SLITTABLE) OUTER GUIDE CATHETER
• Type of Device: CATHETER
• Manufacturer (Section D): ST. JUDE MEDICAL, INC. (CRM-KISTA); 15900 valley view court; sylmar CA 91342
• Manufacturer (Section G): ST. JUDE MEDICAL, INC. (CRM-KISTA); 15900 valley view court; sylmar CA 91342
• Manufacturer Contact: ulla strindlund ; box 7051; isafjordsgatan 15; kista SE-16-407 ; SW SE-16407
• MDR Report Key: 4793348
• MDR Text Key: 19816389
• Report Number: 3010215456-2015-00294
• Device Sequence Number: 1
• Product Code: DQY
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: K092075
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,User Facility,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 04/24/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/22/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 09/30/2017
• Device Model Number: DS2C003
• Device Lot Number: 4845137
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/24/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/23/2014
• 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
• Treatment: 1458Q/86, BPU059739
• Patient Outcome(s): Death; Hospitalization
• Patient Age: 75 YR