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

Model Number G52012

Device Problem Material Perforation (2205)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 06/27/2019

Event Type  malfunction  

Manufacturer Narrative

Pma/510(k) # k092359.Cook (b)(4) ltd (manufacturer) is submitting this report on behalf of (b)(6) (importer).Exemption number: e2016031.Information pertaining manufacturer as follows: importer site contact and address: (b)(6).Importer site establishment registration number: (b)(4).Investigation is still pending.A follow up mdr will be submitted to include the investigation conclusions.

Event Description

The doctor inserted the echo-hd-19-a through the scope.He adjusted the angle and pushed the handle to puncture.However, the handle was not pressed well and the needle did not come out either.The nurse pulled the echo-hd-19-a out and found that sheath was broken.The end of the sheath was hanging broken.The doctor guessed the cause of the sheath being broken - when he pushed the handle, the needle pierced the bent sheath.So sheath was broken.

Event Description

The doctor inserted the echo-hd-19-a through the scope.He adjusted the angle and pushed the handle to puncture.However, the handle was not pressed well and the needle did not come out either.The nurse pulled the echo-hd-19-a out and found that sheath was broken.The end of the sheath was hanging broken.The doctor guessed the cause of the sheath being broken, when he pushed the handle, the needle pierced the bent sheath.So sheath was broken.

Manufacturer Narrative

Pma/510(k)#: k092359.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).The echo-hd-19-a device of lot number: c1588829 involved in this complaint was returned for evaluation, with the original packaging.The packaging was open on receipt.With the information provided, a physical examination and document based investigation was conducted.The device related to this occurrence underwent a laboratory evaluation on the 08aug2019 and 18sep2019.There was a kink at the distal end of the needle.Damage to the sheath was observed.Needle able to advance and retract without issue.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 (c1588829) revealed no discrepancies that could have contributed to this complaint.Upon review of complaints, this failure mode has not occurred previously with this 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: c1588829.There is no evidence to suggest that the customer did not follow the instructions for use.A definitive root cause could not be determined as the circumstances of use cannot be replicated in the laboratory.A possible root cause could be attributed to the needle kinking distally when advancing the device through the endoscope which was in a tortuous position, which may in turn have caused the sheath damage.Complaint is confirmed as the failure was verified in the laboratory.There was a kink at the distal end of the needle.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

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

Event Description

The doctor inserted the echo-hd-19-a through the scope.He adjusted the angle and pushed the handle to puncture.However, the handle was not pressed well and the needle did not come out either.The nurse pulled the echo-hd-19-a out and found that sheath was broken.The end of the sheath was hanging broken.The doctor guessed the cause of the sheath being broken - when he pushed the handle, the needle pierced the bent sheath.So sheath was broken.

• 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: 8842055
• MDR Text Key: 216415634
• Report Number: 3001845648-2019-00377
• Device Sequence Number: 1
• Product Code: FCG
• UDI-Device Identifier: 00827002520127
• UDI-Public: (01)00827002520127(17)220225(10)C1588829
• 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
• Report Date: 08/27/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/30/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 02/25/2022
• Device Model Number: G52012
• Device Catalogue Number: ECHO-HD-19-A
• Device Lot Number: C1588829
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/07/2019
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 07/30/2019
• Event Location: Hospital
• Date Manufacturer Received: 07/04/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1