MAUDE Adverse Event Report: COOK IRELAND LTD ECHOTIP PROCORE ENDOBRONCHIAL HD BIOPSY NEEDLE; FCG KIT, NEEDLE, BIOPSY

Catalog Number ECHO-HD-22-EBUS-P-C

Device Problem Material Deformation (2976)

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

Event Date 03/01/2019

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Investigation is still pending, a follow up mdr will be submitted to include the investigation conclusions.

Event Description

During procedure needle tip kinked within the bronchoscope "as per complaint form": dr.(b)(6), pneumologist.He is there since 3 month.With the first 22 needle he punctured 3 x n11, 1 x n4 and 1 x n7.During the last 5th puncture the needle bent.The needle couldn't placed in the catheter so we decided to bring out both - needle and scope together.Then we called the chief doctor and he called the technician.He bent the needle back so we could place the needle back into the catheter and bring out the needle from scope without any damage.Then he take a new 22 needle and puncture the next not 1 x n10.On the second trial the needle was again hardly to move without any force so that he decided to break up this procedure.In the meantime the department has already ordered and received a new delivery of 10 needles with lot c1578253.But the chief dr.(b)(6) already told me, that he was really happy with this needle in the beginning in 2015 and observed that he had more problems with the needles since the last 3 month.This complaint is related to (b)(4).This complaint was opened as a general complaint to document that the physician experienced "more problems with the needles since the last 3 month".Doc 15-mar-19.Fda mdr reporting required - event is fda mdr reportable based on the device malfunction reporting precedence for this device family for the issue of ¿'non retraction of needle"¿.No patient injury or adverse effects to the patient have been reported as occurring.

Manufacturer Narrative

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).This report is being submitted as a cancellation report.This pr was created as a general complaint for the issues the physician has noted in the last three months, however it has been confirmed that all information available relating to this complaint is included in report # 3001845648-2019-00128 / (b)(4).No adverse effects to the patient was reported as occurring.Complaints of this nature will continue to be monitored for potential emerging trends.

Event Description

This report is being submitted as a cancellation report.Initial report details: during procedure needle tip kinked within the bronchioscope as per complaint form: "(b)(6), pneumologist.He is there since 3 month.With the first 22 needle he punctured 3 x n11, 1 x n4 and 1 x n7.During the last 5th puncture the needle bent (see pictures).The needle couldn't placed in the catheter so we decided to bring out both - needle and scope together.Then we called the chief doctor and he called the technician.He bent the needle back so we could place the needle back into the catheter and bring out the needle from scope without any damage.Then he take a new 22 needle and puncture the next not 1 x n10.On the second trial the needle was again hardly to move without any force so that he decided to break up this procedure.In the meantime the department has already ordered and received a new delivery of 10 needles with lot c1578253.But the chief dr.Seese already told me, that he was really happy with this needle in the beginning in 2015 and observed that he had more problems with the needles since the last 3 month.".

• Brand Name: ECHOTIP PROCORE ENDOBRONCHIAL HD BIOPSY NEEDLE
• Type of Device: FCG KIT, NEEDLE, BIOPSY
• Manufacturer (Section D): COOK IRELAND LTD; o halloran road; limerick
• MDR Report Key: 8463299
• MDR Text Key: 140536177
• Report Number: 3001845648-2019-00129
• 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: 03/29/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/29/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: ECHO-HD-22-EBUS-P-C
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 03/28/2019
• Event Location: Hospital
• Date Manufacturer Received: 03/04/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Weight: 62