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 Problems Break (1069); Material Perforation (2205)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 03/09/2020

Event Type  malfunction  

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 via complaint form "distal- 3mm of sheath began to detached".

Manufacturer Narrative

Device evaluation complaint device was not returned therefore a document based review will be performed.Document review including ifu review 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 manufacturing records for echo-hd-19-a of lot number c1630842 did not reveal any discrepancies that could have contributed to this complaint issue.The review of relevant manufacturing records, confirms the failure mode has not previously occurred with the current lot number.Based on the information available to date, there is no evidence to suggest that there are any manufacturing issues associated with lot number c1630842.The notes section of the instructions for use, ifu0050-2, which accompanies this device instructs the user to inspect the device prior to use for any damage: "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 (ifu0050-2).Root cause review a definitive root cause could not be determined from the available information.A possible root cause could be attributed to the sheath getting caught on some part of the scope during advancement causing the distal end of it to get damaged and begin to detach.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 via complaint form "distal- 3mm of sheath began to detached".Did any section of the device remain inside the patient¿s body? - no.Needle was removed from scope.· if yes, please describe.Did the patient require any additional procedures due to this occurrence? - no · if yes, please describe.Did the product cause or contribute to the need for additional procedures? - no · if yes, please specify additional procedures and provide details.Has the complainant reported any adverse effects on the patient due to this occurrence? - no has the complainant reported that the product caused or contributed to the adverse effects? - no · please specify adverse effects and provide details.

• 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: 9930736
• MDR Text Key: 201856763
• Report Number: 3001845648-2020-00213
• Device Sequence Number: 1
• Product Code: FCG
• UDI-Device Identifier: 10827002520124
• UDI-Public: (01)10827002520124(17)220712(10)C1630842
• 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
• Report Date: 04/30/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/06/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Expiration Date: 07/12/2022
• Device Catalogue Number: ECHO-HD-19-A
• Device Lot Number: C1630842
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 03/09/2020
• Event Location: Hospital
• Date Manufacturer Received: 03/16/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1