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

Model Number DS2N026-59

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

Patient Problem Pneumothorax (2012)

Event Date 08/29/2017

Event Type  Injury  

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 Description

Related manufacturer report number: 2017865-2017-32574, 2938836-2017-32356, 2017865-2017-32575, 2017865-2017-32576, 2017865-2017-32577, 2017865-2017-32578.Following a system implant procedure, diagnostic imaging revealed a left pneumothorax, for which no treatment was required.The patient was asymptomatic and discharged the following day.

• Brand Name: CPS QUARTET INNER-SUB-ACU 135MEAN 59CM
• Type of Device: CATHETER
• Manufacturer (Section D): ST. JUDE MEDICAL, INC.; 15900 valley view court; sylmar CA 91342
• Manufacturer (Section G): ST. JUDE MEDICAL, INC.; 15900 valley view court; sylmar CA 91342
• Manufacturer Contact: denise johnson ; 5050 nathan lane north; plymouth, MN 55442 ; 6517564470
• MDR Report Key: 6905503
• MDR Text Key: 87811205
• Report Number: 2017865-2017-32576
• Device Sequence Number: 1
• Product Code: DQY
• Combination Product (y/n): N
• Reporter Country Code: SP
• PMA/PMN Number: K130252
• 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
• Report Date: 09/29/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/29/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 10/31/2019
• Device Model Number: DS2N026-59
• Device Lot Number: 5723278
• Other Device ID Number: 05415067005717
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/31/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/08/2016
• 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: CPS DIRECT SLITTABLE CATHETER; CPS QUARTET INNER; DURATA STS OPTIM; QUARTET LEAD; TENDRIL STS
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 75 YR