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

Catalog Number ECHO-HD-25-EBUS-O-C

Device Problem Material Deformation (2976)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 11/21/2018

Event Type  Injury  

Manufacturer Narrative

510 (k) number; k160229.(b)(4).Investigation is still pending.A follow up mdr will be submitted to include the investigation conclusions.

Event Description

As reported to customer relations: "while completing an ebus procedure: using a 25g cook pro-tip fna needle.We were attempting to sample a lymphnode, the needle was unable to retract into the sheath, dr.Decided to take scope out of patient.Once scope removed noted that needle was bent at 90 degrees.Straightened needle with wire cutters to remove from scope.Needle checked afterwards it was intact.Patient was re-bronched to rule out injury.Small scratches noted.Patient alert, orientated, and vital signs stable.".

Manufacturer Narrative

510 (k) number; k160229.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)(6).Cook medical incorporated (cmi) (b)(4).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

As reported to customer relations: "while completing a ebus procedure: using a 25g cook pro-tip fna needle.We were attempting to sample a lympnode, the needle was unable to retract into the sheath, dr.Decided to take scope out of patient.Once scope removed noted that needle was bent at 90 degrees.Straightened needle with wire cutters to remove from scope.Needle checked afterwards it was intact.Patient was re-bronched to rule out injury.Small scratches noted.Patient alert, orientated, and vital signs stable.".

Manufacturer Narrative

510 (k) number; k160229.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)(6).Cook medical incorporated (cmi) (b)(4).Importer site establishment registration number: (b)(4).This follow up report is being submitted as the investigation of this event and the conclusion of this investigation is complete.The rep has confirmed that the device is no longer available for evaluation; therefore a document based investigation will be carried out.It was confirmed with the rep that the kink was distal.Complaint is confirmed based on the customer testimony as the complaint device has not been returned for evaluation.Prior to distribution, all echo-hd-25-ebus-o-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 the echo-hd-25-ebus-o-c device could not be performed as the lot number has not been provided.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".A definitive root cause for the customer complaint could not be determined as the complaint device has not been returned for evaluation.A possible root cause may be due to a hard node.As per information provided, the patient had small scratches noted due to this occurrence.Complaints of this nature will continue to be monitored for potential emerging trends.

Event Description

This follow up report is being submitted as the investigation of this event and the conclusion of this investigation is complete.Initial report details: as reported to customer relations: "while completing a ebus procedure: using a 25g cook pro-tip fna needle.We were attempting to sample a lympnode, the needle was unable to retract into the sheath, dr.Decided to take scope out of patient.Once scope removed noted that needle was bent at 90 degrees.Straightened needle with wire cutters to remove from scope.Needle checked afterwards it was intact.Patient was re-bronched to rule out injury, small scratches noted.Patient alert, orientated, and vital signs stable.".

Manufacturer Narrative

510 (k) number; k160229.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)(6).Cook medical incorporated (cmi) (b)(4).Importer site establishment registration number: (b)(4).This follow up report is being submitted due to the evaluation of the device involved in this event and the conclusion of this investigation.1 x echo-hd-25-ebus-o-c was returned to cirl for evaluation.Needle was observed to be kinked both proximally and distally.Resistance was encountered on trying to advance the needle but it was possible to advance.The distal kink most likely led to the proximal kink.Prior to distribution, all echo-hd-25-ebus-o-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 the echo-hd-25-ebus-o-c device could not be performed as the lot number has not been provided.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".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 a hard node.Complaint is confirmed as failure was verified in the laboratory.As per information provided, the patient had small scratches noted due to this occurrence.Complaints of this nature will continue to be monitored for potential emerging trends.

Event Description

This follow up report is being submitted due to the evaluation of the device involved in this event and the conclusion of this investigation.Initial report details: as reported to customer relations: "while completing a ebus procedure: using a 25g cook pro-tip fna needle.We were attempting to sample a lympnode, the needle was unable to retract into the sheath, dr.Decided to take scope out of patient.Once scope removed noted that needle was bent at 90 degrees.Straightened needle with wire cutters to remove from scope.Needle checked afterwards it was intact.Patient was re-bronched to rule out injury, small scratches noted.Patient alert, orientated, and vital signs stable.".

• 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: 8172802
• MDR Text Key: 130616222
• Report Number: 3001845648-2018-00598
• Device Sequence Number: 1
• Product Code: FCG
• 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,Followup,Followup
• Report Date: 02/19/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/18/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: ECHO-HD-25-EBUS-O-C
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/19/2019
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 12/18/2018
• Event Location: Hospital
• Date Manufacturer Received: 11/26/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention