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

Model Number G34785

Device Problem Break (1069)

Patient Problems Injury (2348); Foreign Body In Patient (2687)

Event Date 08/21/2017

Event Type  Injury  

Manufacturer Narrative

Pma/510(k) # k142688.(b)(4).The customer reported the following complaint issue: ¿during fnb operation, the needles broke.In detail, when dr.(b)(6) was puncturing the head of pancreas from duodenum, 8 cm of needle was broken and then the needles tip was embedded in the duodenum." it was originally indicated that the device involved in this complaint was being returned to cook (b)(4) for evaluation; the device has not yet been received, however, if it is returned, the device will be evaluated and the investigation will be updated.As the device was not returned for evaluation; the cause of this complaint could not be conclusively determined.With the information provided a document based investigation was carried out.The customer complaint is considered to be confirmed based on customer testimony.A potential root cause for this event may be caused by hard lesion/torturous anatomy.A definitive root cause for the customer complaint could not be determined as the exact operational conditions of use could not be replicated in the laboratory setting.A review of the qc records did not reveal any issues which could have contributed to this complaint issue.Prior to distribution, all echo-hd-3-20-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.A review of the manufacturing record for echo-hd-3-20-c device did not reveal any discrepancies which could have contributed to this complaint report.The notes section of the instructions for use, ifu0077-4, and precautions section: that accompanies this device instructs the user to ¿ensure the stylet is fully inserted when advancing the needle into the biopsy site, when targeting multiple sites, replace device for each site.¿ from the information provided, during fnb operation , the needles broke.In detail, when dr.(b)(6) was puncturing the head of pancreas from duodenum, 8 cm of needle was broken and then the needles tip was embedded in the duodenum, while removing it with the snare, the needles scratched and bled the esophagus.Complaints of this nature will continue to be monitored for potential emerging trends.

Event Description

During fnb operation , the needles broke.In detail, when dr.(b)(6) was puncturing the head of pancreas from duodenum, 8 cm of needle was broken and then the needles tip was embedded in the duodenum.

Manufacturer Narrative

Pma/510(k) # k142688.(b)(4).Exemption number: e2016031 importer site contact and address: (b)(4).1 x echo-hd-3-20-c was returned to cirl for evaluation.Upon evaluation the following was noted: the device was returned in a plastic pouch.The device, syringe, stylet and needle tip were returned.The needle tip was broken approximately 3cm.The stylet was able to be inserted into the device up to approximately 3cm, no part of the needle is taught to be missing.There were no other issues noted with the device.Complaint was confirmed as the failure was verified in the lab.A potential root cause for this event may be caused by torturous anatomy or possible a torturous position a definitive root cause for the customer complaint could not be determined as the exact operational conditions of use could not be replicated in the laboratory setting.Prior to distribution, all echo-hd-3-20-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 a review of the manufacturing record for echo-hd-3-20-c device of lot number c1344099 did not reveal any discrepancies which could have contributed to this complaint report.The notes section of the instructions for use, and precautions section: that accompanies this device instructs the user to ¿ensure the stylet is fully inserted when advancing the needle into the biopsy site, when targeting multiple sites, replace device for each site."on review of the ifu there is no evidence to show that the customer did not follow the ifu.Complaints of this nature will continue to be monitored for potential emerging trends.

Event Description

This follow up mdr is being submitted as the device was returned and evaluated.During fnb operation , the needles broke.In detail, when dr.(b)(6) was puncturing the head of pancreas frome duodenum, 8cm of needle was broken and then the needles tip was embedded in the duodenum.

• 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
• Manufacturer Contact: michael galvin ; o'halloran road; national technology park; limerick ; 061334440
• MDR Report Key: 6878267
• MDR Text Key: 86699463
• Report Number: 3001845648-2017-00401
• Device Sequence Number: 1
• Product Code: FCG
• UDI-Device Identifier: 00827002347854
• UDI-Public: (01)00827002347854(17)200406(10)C1344099
• Combination Product (y/n): N
• Reporter Country Code: KR
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 10/06/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/20/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: G34785
• Device Catalogue Number: ECHO-HD-3-20-C
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 09/19/2017
• Event Location: Hospital
• Date Manufacturer Received: 10/06/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/06/2017
• 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
• Patient Outcome(s): Required Intervention
• Patient Age: 60 DA