MAUDE Adverse Event Report: COOK INC QUICK-CORE COAXIAL BIOPSY NEEDLE SET; KNW INSTRUMENT, BIOPSY

Model Number	N/A
Medical Device Problem Code	Difficult to Remove (1528)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	10/11/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).No known impact or consequence to patient.Difficult to remove.The event is currently under investigation.A follow-up report will be submitted upon receipt of additional information or completion of the investigation.
Event or Problem Description
The international customer reported that, when used, the quick-core coaxial biopsy needle would not pull out from the cannula.This issue occurred with two separate devices.The procedure was ultimately truncated when the patient developed a pneumothorax.The operator of the device reported that the cause of the pneumothorax is not known.Approximately 30 minutes later, the patient reportedly returned to the ward in stable condition.The patient is currently in good condition.Further information has been requested from the customer, but current no more information is available.The circumstances surrounding the handling and usage of the device leading up to the product issue and subsequent pneumothorax were not reported.The product is reportedly available for return; however, as of the date of this report, no product has yet been received for evaluation.
Additional Manufacturer Narrative
Investigation summary: a review of the complaint history, documentation, device history record, instructions for use(ifu), specifications, drawings, quality control, manufacturing instructions, and functional testing of the returned device were conducted during the investigation.One quickcore biopsy set was returned for evaluation.One prior to use coaxial needle assembly was returned.No quick core biopsy needle was returned.The coaxial needle assembly is made up of a trocar and an outer cannula.The outer cannula and trocar of the coaxial needle assembly were locked together.With excessive force applied, the operator was able to unlock the hubs.Once unlocked, the trocar easily slide in and out of the cannula.Additionally, a document based investigation evaluation was performed.There was no evidence to suggest the product was not made to specifications.A review of the device history record found no non-conforming events.It should be noted there were no other reported complaints for this lot number.Per the conclusion of an internal investigation, it was determined that the issue of unlocking the hubs on the coaxial needle subassembly is potentially two-fold.One potential explanation is due to humidity causing product to swell and another could be attributed to over-torqueing of the hub.Based on the information provided, the examination of the returned product, and the results of our investigation, the root cause is related to manufacturing.Measures have been initiated to correct this issue.Appropriate personnel have been notified and monitoring will continue to be performed for similar complaints.Per the quality engineering risk assessment, no further action is required at this time.

• Brand Name: QUICK-CORE COAXIAL BIOPSY NEEDLE SET
• Common Device Name: KNW INSTRUMENT, BIOPSY
• Manufacturer (Section D): COOK INC; 750 daniels way; bloomington IN 47404
• MDR Report Key: 6980299
• Report Number: 1820334-2017-03647
• Device Sequence Number: 10999008
• Product Code: KNW
• UDI-Device Identifier: 00827002087880
• UDI-Public: (01)00827002087880(17)210913(10)7269188
• Combination Product (Y/N): N
• Initial Reporter Country: CN
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign,user facility
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 01/22/2018

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
• Operator of Device: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: QCS-20-15.0-20T
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: 10/12/2017
• Supplement Date Received by Manufacturer: 01/10/2018
• Initial Report FDA Received Date: 10/26/2017
• Supplement Report FDA Received Date: 01/22/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 63 YR
• Patient Weight: 72