MAUDE Adverse Event Report: HALYARD HEALTH COOLIEF COOLED RF KIT; RF WATER-COOLED PROBES

Model Number CRK-17-150-4

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

Patient Problem Blood Loss (2597)

Event Date 08/16/2016

Event Type  Injury  

Manufacturer Narrative

(b)(4).The actual complaint product was not returned for evaluation.Root cause could not be determined.A review of the device history record is not possible as no lot number was provided.Halyard health has no independent knowledge of the event reported but is relaying the information that was provided by the user facility where the incident occurred.This product incident is documented in the halyard health complaint database and identified as complaint (b)(4).This information is submitted pursuant to 21cfr803, in compliance with the medical device reporting requirement and should not be considered to be an admission that a halyard health product is defective or caused serious injury.Not returned to manufacturer.

Event Description

It was reported that during a cooled rf procedure on a female patient in her late 70s, when the needle was placed for the articular branch of the femoral nerve, the patient began bleeding heavily.It was discovered that the patient was on blood thinner medication up to 24 hours prior to the procedure.The patient was admitted to the intensive care unit for treatment and remained there for seven days before being discharged.No further information has been provided at this time.

• Brand Name: COOLIEF COOLED RF KIT
• Type of Device: RF WATER-COOLED PROBES
• Manufacturer (Section D): HALYARD HEALTH; 5405 windward parkway; alpharetta GA 30004
• Manufacturer (Section G): AVENT S DE RL DE CV; carretera internacional; salida norte no. 1053; magdalena, cp 84160 ; MX 84160
• Manufacturer Contact: lisa clark ; 5405 windward parkway; alpharetta, GA 30004 ; 4704485444
• MDR Report Key: 6058800
• MDR Text Key: 58452802
• Report Number: 8030647-2016-00212
• Device Sequence Number: 1
• Product Code: GXI
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: PK053082
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 08/16/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/26/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: CRK-17-150-4
• Device Catalogue Number: 104420200
• Device Lot Number: UNKNOWN
• Other Device ID Number: 10680651442021
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/16/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention