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

Catalog Number ECHO-HD-19-A

Device Problem Mechanical Problem (1384)

Patient Problems No Consequences Or Impact To Patient (2199); No Known Impact Or Consequence To Patient (2692)

Event Date 06/07/2019

Event Type  malfunction  

Manufacturer Narrative

Pma/510(k) #k092359.Investigation is still pending.A follow up mdr will be submitted to include the investigation conclusions.

Event Description

As reported to customer relations: "wire stripped during the procedure.Boston wire was the wire used with the cook device.Occurred during an exchange.Customer couldn't finish procedure as intended, customer had to send patient to ir, where the procedure was completed (via some other technique).Nothing was left in the patient." additional information provided by customer on 19sep2019: "can you please confirm if the allegation is that the ¿wire stripping" of the boston wire was a result of the echotip? i believe so, i can confirm with the doctor when i see him next".

Manufacturer Narrative

Investigation is still pending, a follow up mdr will be submitted to include the investigation conclusions.

Event Description

As reported to customer relations: "wire stripped during the procedure.Boston wire was the wire used with the cook device.Occurred during an exchange.Customer couldn't finish procedure as intended, customer had to send patient to ir, where the procedure was completed (via some other technique).Nothing was left in the patient." additional information provided by customer on 19sep2019: "can you please confirm if the allegation is that the ¿wire stripping" of the boston wire was a result of the echotip? i believe so, i can confirm with the doctor when i see him next".

Event Description

As reported to customer relations: "wire stripped during the procedure.Boston wire was the wire used with the cook device.Occurred during an exchange.Customer couldn't finish procedure as intended, customer had to send patient to ir, where the procedure was completed (via some other technique).Nothing was left in the patient." additional information provided by customer on 19-sep-2019: "can you please confirm if the allegation is that the ¿wire stripping" of the boston wire was a result of the echotip? i believe so, i can confirm with the doctor when i see him next.".

Manufacturer Narrative

Pma/510(k) #k092359.The echo-hd-19-a device of unknown lot number involved in this complaint was not available for evaluation.With the information provided, a document based investigation was conducted.Device did not return.Prior to distribution, all echo-hd-19-a 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.A review of the relevant manufacturing records could not be conducted as the lot number is unknown.There is no evidence to suggest that the customer did not follow the instructions for use.A definitive root cause could not be determined from the available information.A possible root cause could be attributed to the use of the device in a flexed/twisted position.The complaint is confirmed based on customer 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.

Manufacturer Narrative

Investigation is still pending, a follow up mdr will be submitted to include the investigation conclusions.

Event Description

As reported to customer relations: "wire stripped during the procedure.Boston wire was the wire used with the cook device.Occurred during an exchange.Customer couldn't finish procedure as intended, customer had to send patient to ir, where the procedure was completed (via some other technique).Nothing was left in the patient." additional information provided by customer on 19sep2019: "can you please confirm if the allegation is that the ¿wire stripping" of the boston wire was a result of the echotip? i believe so, i can confirm with the doctor when i see him next" fda mdr reporting required - event is fda mdr reportable based on the device malfunction reporting precedence for this device family for the issue of ¿wire guide peeling / stripping¿.

• Brand Name: ECHOTIP ULTRA HIGH DEFINITION ULTRASOUND ACCESS NEEDLE
• Type of Device: FCG KIT, NEEDLE, BIOPSY
• Manufacturer (Section D): COOK IRELAND LTD; o halloran road; limerick
• MDR Report Key: 9150179
• MDR Text Key: 189903135
• Report Number: 3001845648-2019-00507
• Device Sequence Number: 1
• Product Code: FCG
• Combination Product (y/n): N
• PMA/PMN Number: K092359
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 11/29/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/03/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: ECHO-HD-19-A
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 06/07/2019
• Event Location: Hospital
• Date Manufacturer Received: 09/09/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1