MAUDE Adverse Event Report: COOK IRELAND LTD QUICK-CORE ULTRASOUND BIOPSY NEEDLE; FCG KIT, NEEDLE, BIOPSY

Catalog Number EUSN-19-QC

Device Problem Material Deformation (2976)

Patient Problem Foreign Body In Patient (2687)

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

Literature complaint: comparison of eus-guided tissue acquisition using two different 19-gauge core biopsy needles: a multicenter, prospective, randomized, and blinded study.Dewitt (2015).As reported to customer relations: "the needle fractured during pancreatic tissue sampling.The authors noted that several factors contributed to this event (i.E., long endoscope position, difficult depression of the plunger, slight elevator use, and acute needle angle into the target).The patient underwent pancreatoduodenectomy 6 weeks later for treatment of the underlying disease and foreign body removal.".

Event Description

Event was noted on review of the following journal article; john dewitt1, chang-min cho1, jingmei lin2, mohammad al-haddad1, marcia irene canto3, ashley salamone3, ralph h.Hruban4, ahmed a.Messallam3, mouen a.Khashab3."comparison of eus-guided tissue acquisition using two different 19-gauge core biopsy needles: a multicenter, prospective, randomized, and blinded study." as reported to customer relations: "the needle fractured during pancreatic tissue sampling.The authors noted that several factors contributed to this event (i.E., long endoscope position, difficult depression of the plunger, slight elevator use, and acute needle angle into the target).The patient underwent pancreatoduodenectomy 6 weeks later for treatment of the underlying disease and foreign body removal.".

Manufacturer Narrative

510 (k) number: cook ireland ltd (manufacturer) is submitting this report on behalf of cook medical incorporated (cmi)(importer).Exemption number: e2016031.Information pertaining to section g.1 as follows: importer site contact and address: (b)(4) cook medical incorporated (cmi) 1025 acuff road p.O box 4195 bloomington indiana 47402-4195.Importer site establishment registration number: 3005580113.Device evaluation; the eusn-19-qc device of unknown lot number involved in this complaint was not returned for evaluation.With the information provided document based investigation was conducted.The customer complaint is considered to be confirmed based on customer testimony.A definitive root cause for the customer complaint could not be determined.Possibly the needle fracture occurred due to tortuous pathway or due to hard lesion.As the eusn-19-qc is from an unknown lot number, a review of the relevant manufacturing records cannot be conducted.Prior to distribution, all eusn-19-qc devices are subjected to functional checks and visual inspection to ensure device integrity.The patient underwent pancreatoduodenectomy 6 weeks later for treatment of the underlying disease and foreign body removal.The customer complaint is considered to be confirmed based on customer testimony.Complaints of this nature will continue to be monitored for potential emerging trends.

• Brand Name: QUICK-CORE ULTRASOUND BIOPSY NEEDLE
• Type of Device: FCG KIT, NEEDLE, BIOPSY
• Manufacturer (Section D): COOK IRELAND LTD; o halloran road; limerick
• MDR Report Key: 7852156
• MDR Text Key: 119489813
• Report Number: 3001845648-2018-00418
• Device Sequence Number: 1
• Product Code: FCG
• Combination Product (y/n): N
• PMA/PMN Number: K013356
• 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: 09/06/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/06/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: EUSN-19-QC
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 08/14/2018
• Event Location: Hospital
• Date Manufacturer Received: 08/17/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention