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

Catalog Number ECHO-19

Device Problems Off-Label Use (1494); Material Perforation (2205)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 04/09/2020

Event Type  malfunction  

Manufacturer Narrative

Investigation is still pending.A follow-up /final vigilance report will be submitted to include the investigation conclusions.

Event Description

User detected the needle penetrated the surface of sheath and cannot continue biopsy.User retracted the device and cut part of sheath off and needle tip was exposed which cannot be used to pick the biopsy any more.User changed another same device to complete the procedure.A section of the device did not remain inside the patient¿s body.The patient did not require any additional procedures due to this occurrence.According to the initial reporter, the patient did not experience any adverse effects due to this occurrence.".

Manufacturer Narrative

Investigation is still pending.A follow-up report will be submitted to include the investigation conclusions.

Event Description

Follow up report is being submitted to indicate the device has been returned.User detected the needle penetrated the surface of sheath and cannot continue biopsy.User retracted the device and cut part of sheath off and needle tip was exposed which cannot be used to pick the biopsy any more.User changed another same device to complete the procedure.A section of the device did not remain inside the patient¿s body.The patient did not require any additional procedures due to this occurrence.According to the initial reporter, the patient did not experience any adverse effects due to this occurrence.".

Event Description

This is a follow up report.The investigation was completed on (b)(6) 2020.Results and conclusions are outlined in section h of this report.User detected the needle penetrated the surface of sheath and cannot continue biopsy.User retracted the device and cut part of sheath off and needle tip was exposed which cannot be used to pick the biopsy any more.User changed another same device to complete the procedure.A section of the device did not remain inside the patient¿s body.The patient did not require any additional procedures due to this occurrence.According to the initial reporter, the patient did not experience any adverse effects due to this occurrence.

Manufacturer Narrative

Device evaluation: 1 unit of lot c1619851 of echo-19 involved in this complaint was returned for evaluation, with the original packaging.With the information provided, a physical examination and document based investigation was conducted.Lab evaluation: the device involved in the complaint was evaluated in the laboratory on (b)(6) 2020.In summary the following results were observed in the lab evaluation: device functioned as intended.Tip of the sheath appears to be cut.Sheath extender advanced and retract without any difficulties.No kinks or deformation on distal end of needle observed.Needle advanced and retract without any issues.Stylet removed and no defects observed.Needle removed from the device and no defect observed.Document review including ifu review prior to distribution, all echo-19 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-19 of lot number c1619851 did not reveal any discrepancies that could have contributed to this complaint issue.There is no evidence to suggest that this issue affects the entire lot # c1619851; upon review of complaints this failure mode has not occurred previously with this lot # c1619851.The notes section of the instructions for use, se, ifu0101-1, which accompanies this device instructs the user "this device is used to sample targeted submucosal gastrointestinal lesions through the accessory channel of an ultrasound endoscope." there is evidence to suggest that the customer did not follow the instructions for use, from the information provided, the location in the body for the intended target site was mediastinum.As per engineering input: "the physician/assistant used the device in a situation not specified for intended use.Root cause review: a definitive root cause could be determined from the available information.From the information provided, the location in the body for the intended target site was mediastinum, this would be off-label use.As per engineering input, "the ¿needle penetrated the surface of sheath¿ could have occurred due to the fact the physician/assistant used the device in a situation not specified for intended use summary: complaint is confirmed based on the customer's testimony.According to the initial reporter, the patient did experience any adverse effects due to this occurrence.From additional information received "customer just confirmed the procedure was complete with same lot# of complaint product." complaints of this nature will continue to be monitored for potential emerging trends.

• Brand Name: ECHOTIP ULTRA ENDOSCOPIC ULTRASOUND NEEDLE
• Type of Device: FCG KIT, NEEDLE, BIOPSY
• Manufacturer (Section D): COOK IRELAND LTD; o halloran road; limerick
• MDR Report Key: 10033517
• MDR Text Key: 191889483
• Report Number: 3001845648-2020-00288
• Device Sequence Number: 1
• Product Code: FCG
• UDI-Device Identifier: 10827002315201
• UDI-Public: (01)10827002315201(17)220605(10)C1619851
• Combination Product (y/n): N
• PMA/PMN Number: K083330
• 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: 07/15/2020

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: 06/05/2022
• Device Catalogue Number: ECHO-19
• Device Lot Number: C1619851
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/06/2020
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 04/09/2020
• Event Location: Hospital
• Initial Date Manufacturer Received: 05/07/2020
• Initial Date FDA Received: 05/07/2020
• Supplement Dates Manufacturer Received: 04/10/2020; 04/10/2020
• Supplement Dates FDA Received: 06/05/2020; 07/28/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 51 YR
• Patient Weight: 53