MAUDE Adverse Event Report: COOK INC QUICK-CORE COAXIAL BIOPSY NEEDLE SET; GCA CATHETER, BILIARY, DIAGNOSTIC CATHETER, NEPHROSTOMY

Catalog Number QCS-18-15.0-20T

Device Problem Difficult to Remove (1528)

Patient Problem No Patient Involvement (2645)

Event Date 06/25/2018

Event Type  malfunction  

Manufacturer Narrative

Pma/510(k) #: not exempt; pma/510(k) #: pre-amendment.(b)(4).This report includes information known at this time.A follow up report will be submitted should additional relevant information become available.

Event Description

As reported, a quick-core coaxial biopsy needle set was to be used during a transthoracic needle biopsy procedure.The physician opened the package and found that the handle of the device was too tight to open.A new device was then opened to complete the procedure.Preliminary investigation findings for the returned device found that it was possible the handle was screwed on too tightly during the manufacture of the complaint device.The defective device did not make patient contact.

Event Description

It was reported a quick-core coaxial biopsy needle set was to be used during a transthoracic needle biopsy procedure.The physician opened the package and found that the handle of the device was too tight to open.A new device was then opened and experienced the same difficulties.A third device was used to complete the procedure.The defective devices did not make patient contact.As reported, the patient did not experience any adverse effects or require any additional procedures due to this occurrence.

Manufacturer Narrative

Blank fields on this form indicate the information is unchanged, unknown or unavailable.Correction: event description: it was initially reported one device was found difficult to operate prior to patient contact and then the procedure was completed with a second device.The updated description accurately describes two devices that were found difficult to operate prior to patient contact and a third device used to complete the procedure.Investigation evaluation: a review of the complaint history, device history record, instructions for use (ifu), drawings, manufacturing instructions, quality control, and specifications of the device, as well as a visual inspection, dimensional verification, functional test, and supplier investigation, were conducted during the complaint investigation.Two unused devices were returned for investigation.A visual inspection revealed no damage to the devices.A functional test revealed that both devices exhibited difficulty in separating the stylet from the cannula.The failure could be recreated if the device was forcibly tightened.Both the outer diameter of the stylet and inner diameter of the cannula were measured to be within specifications.Additionally, a document based investigation evaluation was performed.A review of the device history record showed no non-conformances for the complaint device lot or related sub-assembly.It should be noted there were no other reported complaints for this lot.The instructions for use (ifu) advise the user to inspect the device prior to use to ensure that no damage has occurred.A component of the device related to the malfunction is supplied to cook by an external supplier.A supplier investigation was requested for this occurrence.The supplier investigated the lot records for the supplied subassembly components and found no non-conformances.The supplier concluded the failure mode did not seem to be associated with supplier processes.Based on the information provided, an examination of returned product, and the results of our investigation, the root cause was determined to most likely be manufacturing related.Specifically, the cause is traced to a quality control deficiency.There is no quality control step directly addressing this failure mode.The appropriate personnel have been notified.Appropriate measures are being conducted to address this failure mode.Per the quality engineering risk assessment no further action is required.Cook will continue to monitor for similar complaints.This report is required by the fda under 21 cfr part 803 and is based on unconfirmed information submitted by others.Neither the submission of this report nor any statement contained herein is intended to be an admission that any cook device is defective or malfunctioned, that a death or serious injury occurred, nor that any cook device caused, contributed to, or is likely to cause or contribute to a death or serious injury if a malfunction occurred.

• Brand Name: QUICK-CORE COAXIAL BIOPSY NEEDLE SET
• Type of Device: GCA CATHETER, BILIARY, DIAGNOSTIC CATHETER, NEPHROSTOMY
• Manufacturer (Section D): COOK INC; 750 daniels way; bloomington IN 47404
• MDR Report Key: 7801207
• MDR Text Key: 117852307
• Report Number: 1820334-2018-02457
• Device Sequence Number: 1
• Product Code: GCA
• UDI-Device Identifier: 00827002087903
• UDI-Public: (01)00827002087903(17)221010(10)8279506
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,foreign,health pr
• Type of Report: Initial,Followup
• Report Date: 08/21/2018

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: 10/10/2022
• Device Catalogue Number: QCS-18-15.0-20T
• Device Lot Number: 8279506
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/10/2018
• Initial Date Manufacturer Received: 07/30/2018
• Initial Date FDA Received: 08/21/2018
• Supplement Dates Manufacturer Received: 01/23/2019
• Supplement Dates FDA Received: 02/11/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 69 YR
• Patient Weight: 54