MAUDE Adverse Event Report: COOK IRELAND LTD ECHOTIP PROCORE HIGH DEFINITION ULTRASOUND BIOPSY NEEDLE; FCG KIT, NEEDLE, BIOPSY

Catalog Number ECHO-HD-19-C

Device Problem Material Deformation (2976)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Type  malfunction  

Manufacturer Narrative

510 (k) number: k142688.(b)(4).Investigation is still pending.A follow up mdr will be submitted to include the investigation conclusions.

Event Description

As reported to customer relations "when the doctor pushed the needle out of the sheath, she could not retract it.She pulled really hard but it would not retract.The doctor said that she did not notice any bends or kinks in the needle.The scope had been torqued.This occurred with two device in the same procedure.".

Manufacturer Narrative

510 (k) number; k142688.Cook ireland ltd (manufacturer) is submitting this report on behalf of cook medical incorporated (cmi)(importer).Exemption number: e2016031.Information pertaining to (b)(4).Importer site establishment registration number: (b)(4).Device evaluation complaint devices were not returned therefore a document based review was performed.Document review prior to distribution, all echo-hd-19-c devices are subjected to functional checks and visual inspection to ensure device integrity.These inspections and functional checks are outlined in internal procedures in place at cirl.As the lot number is unknown the device history records could not be reviewed as part of the investigation.Ifu review the notes section of the instructions for use, ifu0077-4, which accompanies this device instructs the user to inspect the device prior to use : "visually inspect with particular attention to kinks, bends and breaks.If an abnormality is detected that would prohibit proper working condition, do not use".There is no evidence to suggest that the customer did not follow the instructions for use (ifu0077-4 ).Root cause review the failure of retraction of needle was concluded from the available information.A definitive root cause could not be determined from the available information.A possible cause could be attributed to a combination of tortuous anatomy and the device being used in a flexed or twisted position during the procedure as indicated in the additional information.Summary complaint is confirmed based on the customer's testimony.According to the initial reporter, the patient did not experience any adverse effects due to this occurrence.Complaints of this nature will continue to be monitored for potential emerging trends.

Event Description

As reported to customer relations "when the doctor pushed the needle out of the sheath, she could not retract it.She pulled really hard but it would not retract.The doctor said that she did not notice any bends or kinks in the needle.The scope had been torqued.This occurred with two device in the same procedure.".

• Brand Name: ECHOTIP PROCORE HIGH DEFINITION ULTRASOUND BIOPSY NEEDLE
• Type of Device: FCG KIT, NEEDLE, BIOPSY
• Manufacturer (Section D): COOK IRELAND LTD; o halloran road; limerick
• MDR Report Key: 8202697
• MDR Text Key: 131916783
• Report Number: 3001845648-2018-00614
• Device Sequence Number: 1
• Product Code: FCG
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup
• Report Date: 12/28/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/28/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: ECHO-HD-19-C
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 12/28/2018
• Event Location: Hospital
• Date Manufacturer Received: 12/03/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1