MAUDE Adverse Event Report: COOK IRELAND LTD ECHOTIP INSIGHT PORTOSYSTEMIC PRESSURE GRADIENT MEASUREMENT SYSTEM; ENDOSCOPIC TRANSHEPATIC VENOUS ACCESS NEEDLE

Model Number G46560

Device Problems Material Twisted/Bent (2981); Physical Resistance/Sticking (4012)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 04/17/2023

Event Type  malfunction  

Manufacturer Narrative

Pma/510(k) # den180062.Product code: qij.Investigation is still pending, a follow up mdr will be submitted to include the investigation conclusions.

Event Description

Reported by the dm on behalf of the customer via email - yesterday during a eus procedure which the physician was trying to attain a portal pressure gradient and they couldn¿t advance the needle from the scope.The patient was never punctured with this device and they removed scope from patient and tried to advance needle in which it remained unsuccessful.We switch to a new device needle and the case was successfully completed.The following has been requested- jm (b)(6)2023: did any unintended section of the device remain inside the patient¿s body? if yes, please describe.Did the patient require any additional procedures due to this occurrence? did the product cause or contribute to the need for additional procedures? if yes, please specify additional procedures and provide details.Has the complainant reported any adverse effects on the patient due to this occurrence? has the complainant reported that the product caused or contributed to the adverse effects? please specify adverse effects and provide details.Was the patient hospitalized or was there prolonged hospitalization due this occurrence? the following has been answered- jm (b)(6)2023 did any unintended section of the device remain inside the patient¿s body? no if yes, please describe.Did the patient require any additional procedures due to this occurrence? no 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.Was the patient hospitalized or was there prolonged hospitalization due this occurrence? no, new was used and procedure was successfully completed after verification, no additional manufacturer questions apply to this gpn/rpn.Jm (b)(6)2023.

Manufacturer Narrative

Product code qij pma 510k # (b)(4).Device evaluation 1 unit of lot c1999588 of echo-ppg was returned opened in its original packaging.The device related to this occurrence underwent a laboratory evaluation a proximal kink below the sheath extender was observed.The needle was unable to advance or retract.Manufacturing records prior to distribution, all echo-ppg devices are subjected to a visual inspection and functional inspection to ensure device integrity.A review of the manufacturing records for echo-ppg of lot number c1999588 did not reveal any discrepancies that could have contributed to this complaint issue.Review historical data the review of relevant manufacturing records confirms the failure mode has not previously occurred for this work order.Instructions for use and/label the notes section of the instructions for use, ifu0123 which accompanies this device instructs the user to; "visually inspect the device with particular attention to kinks, bends and breaks.If a device 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 ((b)(4)).Image review an image was not returned for evaluation.Root cause analysis a definitive root cause for the customer complaint could not be determined as circumstances of use cannot be replicated in the laboratory.A possible root cause could be attributed to damage during set up, insertion/advancement down the scope resulting in the needle kinking below the sheath extender leading to the resulting difficulty with the needle advancing.Summary complaint is confirmed based on visual and/or functional inspection.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 similar events.

Event Description

Supplement report being submitted due to the completion of the investigation on (b)(6) 2023.

• Brand Name: ECHOTIP INSIGHT PORTOSYSTEMIC PRESSURE GRADIENT MEASUREMENT SYSTEM
• Type of Device: ENDOSCOPIC TRANSHEPATIC VENOUS ACCESS NEEDLE
• Manufacturer (Section D): COOK IRELAND LTD; o halloran road; limerick
• Manufacturer (Section G): COOK IRELAND LTD; o halloran road; national technology park; limerick
• Manufacturer Contact: sinead o'leary ; o halloran road; national technology park; limerick
• MDR Report Key: 17225570
• MDR Text Key: 318287576
• Report Number: 3001845648-2023-00507
• Device Sequence Number: 1
• Product Code: QIJ
• UDI-Device Identifier: 00827002465602
• UDI-Public: (01)00827002465602(17)230930(10)C1999588
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 10/05/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 09/30/2023
• Device Model Number: G46560
• Device Catalogue Number: ECHO-PPG
• Device Lot Number: C1999588
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/22/2023
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 04/17/2023
• Event Location: Hospital
• Initial Date Manufacturer Received: 04/18/2023
• Initial Date FDA Received: 06/29/2023
• Supplement Dates Manufacturer Received: 04/18/2023
• Supplement Dates FDA Received: 11/03/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/10/2022
• 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