MAUDE Adverse Event Report: ST. JUDE MEDICAL, INC.(CRM-SYLMAR) CPS QUARTET INNER-SUB-ACU 135MEAN 59CM; CATHETER

Model Number DS2N026-59

Device Problem Device Operates Differently Than Expected (2913)

Patient Problem Vascular Dissection (3160)

Event Date 11/07/2017

Event Type  Injury  

Manufacturer Narrative

The results of the investigation are inconclusive as the device was not returned for analysis.Based upon the information we received, the cause of the reported incident could not be conclusively determined.

Event Description

It was reported that while attempting to implant a left ventricular lead, the physician dissected the patient¿s coronary sinus while trying to advance the outer catheter as the physician advanced the left ventricular lead into a branch.The lead was not placed.There were no adverse patient effects as a result.

• Brand Name: CPS QUARTET INNER-SUB-ACU 135MEAN 59CM
• Type of Device: CATHETER
• Manufacturer (Section D): ST. JUDE MEDICAL, INC.(CRM-SYLMAR); 15900 valley view court; sylmar CA 91342
• Manufacturer (Section G): ST. JUDE MEDICAL, INC.(CRM-SYLMAR); 15900 valley view court; sylmar CA 91342
• Manufacturer Contact: robert greenleaf ; 15900 valley view court; sylmar, CA 91342 ; 8184932577
• MDR Report Key: 7047080
• MDR Text Key: 92584001
• Report Number: 2017865-2017-34868
• Device Sequence Number: 1
• Product Code: DQY
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K130252
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 11/20/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/20/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 05/31/2020
• Device Model Number: DS2N026-59
• Device Lot Number: 6015452
• Other Device ID Number: 05415067005717
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/07/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/07/2017
• 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): Required Intervention
• Patient Age: 70 YR