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

Model Number G31519

Device Problem Material Deformation (2976)

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

Event Date 08/27/2018

Event Type  malfunction  

Manufacturer Narrative

The 510 (k) number: k083330.(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, "it came out of the package with a kink in the sheath and the needle would not advance.They opened another device to complete the procedure successfully.".

Manufacturer Narrative

510(k) number: k851962.Cook ireland ltd (manufacturer) is submitting this report on behalf of cook medical incorporated (cmi)(importer).Exemption number: e2016031.Information pertaining (b)(4).Importer site establishment registration number: (b)(4).The clso-10-7 device of lot c1476463 involved in this complaint was returned for evaluation, opened but with the original packaging.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 (b)(6) 2018.It should be noted that the customer stated in additional information that a 7 french pushing catheter (pc-7 was used to push the stent, however the pc-7 is not compatible with the clso-10-7 therefore it would not be able to push the stent passed the stricture.The complaint is confirmed as user error based on customer testimony.The relevant cook product manager has been contacted to offer retraining to the customer involved in this complaint, to prevent future occurrence documents review: a review of the manufacturing records for the clso-10-7 of lot c1476463 did not reveal any discrepancies that could have contributed to this complaint.Upon review of the complaints history, this failure has not occurred previously with this lot.Prior to distribution, all clso-10-7 devices are subject to visual inspection and functional checks to ensure device integrity.There is also a visual inspection of the product and packaging at packaging, packaging qc, and post sterile qc.It should be noted that this complaint is not related to a device malfunction, this complaint is related to user error.Ifu review: it should be noted that as per the instructions for use (ifu0045-6) precautions section the user is instructed to "select the cook introducer system(if not included) in the appropriate french size" and in the contraindications section the user is advised that "an inability to pass wire or stent through the obstructed area" is contraindicated.Root cause: a possible root cause of user error as per the evidence received in the customer additional information.The customer stated in additional information received that a 7 french sized pushing catheter was used to push the 10 french sized stent, however these devices are not compatible therefore it was not possible to push the stent.The product manager has been contacted to offer retraining to the customer to prevent further occurrence.Summary the complaint is confirmed as user error based on customer testimony.The risk was determined to be no risk (category iii).According to the initial reporter, the patient did not experience any adverse effects due to this occurrence.

• Brand Name: ECHOTIP ULTRA ENDOSCOPIC ULTRASOUND NEEDLE
• Type of Device: FCG KIT, NEEDLE, BIOPSY
• Manufacturer (Section D): COOK INC; 750 daniels way; bloomington IN 47404
• MDR Report Key: 7906154
• MDR Text Key: 122011927
• Report Number: 3001845648-2018-00442
• Device Sequence Number: 1
• Product Code: FCG
• UDI-Device Identifier: 00827002315198
• UDI-Public: (01)00827002315198(17)210130(10)C1448439
• 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
• Report Date: 09/24/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/25/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 01/30/2021
• Device Model Number: G31519
• Device Catalogue Number: ECHO-25
• Device Lot Number: C1448439
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/18/2018
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 08/27/2018
• Event Location: Hospital
• Date Manufacturer Received: 08/27/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1