MAUDE Adverse Event Report: COOK IRELAND LTD ECHOTIP PROCORE ENDOBRONCHIAL HD BIOPSY NEEDLE; FCG KIT, NEEDLE, BIOPSY

Model Number G34279

Device Problem Break (1069)

Patient Problem Foreign Body In Patient (2687)

Event Date 10/03/2019

Event Type  Injury  

Manufacturer Narrative

Pma/510(k) #k160229.Investigation is still pending.A follow up mdr will be submitted to include the investigation conclusions.

Event Description

Per dr.(b)(6) via email: the needle bent at the patient end and broke off when the scope was withdrawn.There was no issue on visual inspection of the needle beforehand, after the procedure, the end of the needle was not present.The needle remnant advanced through the sheath without issue.

Manufacturer Narrative

Pma/510(k) #k160229 1 unit of echo-hd-22-ebus-p-c of lot number c1631930 was returned opened not in its original packaging.The device involved in the complaint was evaluated in the laboratory.The needle was found to be broken distally.Prior to distribution, all echo-hd-22-ebus-p-c 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-22-ebus-p-c of lot number c1631930 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 c1631930.The notes section of the instructions for use, which accompanies this device instructs the user to; "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.The failure of needle broken was observed in the laboratory.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to hard lesion as the needle became bent/kinked after hitting against the trachea and then broke when the scope was withdrawn as indicated in the additional information and complaint description.Complaint is confirmed as the failure was verified in the laboratory.According to the initial reporter, the patient did not experience any adverse effects due to this occurrence.The patient will be followed to monitor for issues related to this occurrence.Complaints of this nature will continue to be monitored for potential emerging trends.

Event Description

Per dr.(b)(6) via email: the needle bent at the patient end and broke off when the scope was withdrawn.There was no issue on visual inspection of the needle beforehand, after the procedure, the end of the needle was not present.The needle remnant advanced through the sheath without issue.

• Brand Name: ECHOTIP PROCORE ENDOBRONCHIAL HD BIOPSY NEEDLE
• Type of Device: FCG KIT, NEEDLE, BIOPSY
• Manufacturer (Section D): COOK IRELAND LTD; o halloran road; limerick
• MDR Report Key: 9248678
• MDR Text Key: 164854560
• Report Number: 3001845648-2019-00568
• Device Sequence Number: 1
• Product Code: FCG
• UDI-Device Identifier: 00827002342798
• UDI-Public: (01)00827002342798(17)220716(10)C1631930
• Combination Product (y/n): N
• 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: 10/29/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 07/16/2022
• Device Model Number: G34279
• Device Catalogue Number: ECHO-HD-22-EBUS-P-C
• Device Lot Number: C1631930
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/12/2019
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 10/03/2019
• Event Location: Hospital
• Initial Date Manufacturer Received: 10/03/2019
• Initial Date FDA Received: 10/29/2019
• Supplement Dates Manufacturer Received: 10/03/2019
• Supplement Dates FDA Received: 11/26/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 62 YR