MAUDE Adverse Event Report: COOK INC NEFF PERCUTANEOUS ACCESS SET; KGZ ACCESSORIES, CATHETER

Model Number	N/A
Medical Device Problem Codes	Material Separation (1562); Difficult to Advance (2920)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	06/11/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Occupation: sister.Pma/510(k) #: exempt.This report includes information known at this time.A follow up report will be submitted should additional relevant information become available.
Event or Problem Description
It was reported a female patient required the use of a neff percutaneous access set for a right sided percutaneous transhepatic cholangiography procedure.When inserting the wire, the operator noted the wire felt "resistant and scratchy on manipulating." when it was removed, the wire appeared "damaged." another wire was used, and upon removal resistance was felt.Imaging showed a portion of the wire was retained in the liver parenchyma.The fragment remains inside the patient's body and there is currently no plan to attempt of the wire fragment.No other adverse events were reported.Upon return and inspection of the device it was discovered that the first wire also separated.The first wire that was separated is reported under medwatch report with patient identifier (b)(6) (this report).The second wire that was separated where a portion of the wire remained in the patient is reported under medwatch report #: 1820334-2020-01157.
Additional Manufacturer Narrative
Additional methods code: communication/interviews (4111).Investigation / evaluation: a representative from north hampshire hospital informed cook an incident involving three neff percutaneous access sets.On (b)(6) 2020 during a percutaneous transhepatic cholangiography procedure the wire felt resistant and scratchy upon introduction.The wire was removed and found it was damaged.A second set was opened and again the wire felt resistant and scratchy upon introduction.This wire was removed and found it was damaged as well.A third set was opened and again the wire felt resistant and scratchy upon introduction.When removing the third wire, resistance was felt and found the wire separated with a piece left in the liver parenchyma.This distal fragment has been left in the patient.There are no plans to remove the wire fragment and the patient has not experienced any adverse effects due to these occurrences.The procedure was completed using a similar device from another manufacturer.Upon return of the three complaint wire guides, one was returned kinked and two were returned separated.A report was previously submitted under medwatch report # 1820334-2020-01157 to capture the wire guide that separated and left a portion in the patient.This report is for the wire guide that separated outside of the patient.A review of the complaint history, device history record, manufacturing instructions, quality control, and specifications of the device, as well as a visual inspection and functional test, were conducted during the investigation.The complainant returned three wire guides and three needle cannula / trocar to cook for investigation.Physical examination of the returned devices showed biomatter present.Two wires were returned separated and the other wire was returned kinked.Two of the three needle cannula/trocar combos were free of damage.The third needle cannula / trocar combo was bowed at 4cm from the distal end of cannula.For the separated wire guides, the weld balls are missing.The inner wire separated from the weld resulting in coil elongation.Due to the damage, no measurements could be taken.All damage is towards the distal end.All trocar stylets were inserted in the needle cannula without difficulty and moved freely.No drag or resistance was felt.A green.018" wire inserted (same as supplied with the npas set) was used to insert a wire through each needle cannula.The wire was able to be inserted without difficulty and moved freely through the cannula to exit the distal end.The coiled end was pulled back into the distal end of needle cannula and wire removed without damage.The failure could not be duplicated in the lab because there was no resistance or damage to the wire guide upon insertion and removal through the needle cannula.Additionally, a document based investigation evaluation was performed.Sufficient inspection activities are in place to identify this failure mode prior to distribution.The risks associated with these devices are acceptable when weighed against the benefits.All tested devices met the acceptance criterion for their tensile test peak loads for the wire guide.The product labeling could not be reviewed because no product¿s instructions for use [ifu] exists for a neff percutaneous access set.A review of the device history record (dhr) was also conducted as a part of the investigation.The dhr for the complaint lot and related subassembly lots found no related nonconformances.A database search was completed on the lot and two additional complaints were found.These complaints were to capture the other two wires reported during the same event.The wire guide subassembly lot filled another final lot.This final lot was examined and there were no related nonconformances or complaints on that lot.As there are adequate inspection activities established, objective evidence that the dhr was fully executed and no related non-conformance, it was concluded that there is no evidence that nonconforming product exists in house or in field.Findings of this investigation revealed no evidence to suggest the device was manufactured out of specification.The wire guide tip could have been caught on the introducing needle which can result in damage to the wire guide.However, a response from the user indicated that the user knows not to manipulate the wire through the needle.When the wire guide is manufactured, it is checked 100% before release and no related nonconformances or complaints from other facilities were recorded.The patient¿s anatomy may make withdrawal or manipulation of the wire guide difficult which can also result in damage.Because the failure occurred 3 times in the same patient, with no evidence of manufacturing issues, other complaints, or use error, it is likely that patient anatomy and / or the specific environment presented by this procedure are the major contributors to the failure.Based on the information provided, the examination of the returned product, and the results of the investigation, the investigation conclusion for this complaint is adverse event related to procedure.The appropriate personnel have been notified.Cook will continue to monitor for similar complaints.Per the quality engineering risk assessment no further action is required.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.
Event or Problem Description
No additional information regarding the patient and/or event has been received since the previous medwatch report was sent.

• Brand Name: NEFF PERCUTANEOUS ACCESS SET
• Common Device Name: KGZ ACCESSORIES, CATHETER
• Manufacturer (Section D): COOK INC; 750 daniels way; bloomington IN 47404
• MDR Report Key: 10304263
• Report Number: 1820334-2020-01335
• Device Sequence Number: 18961659
• Product Code: KGZ
• UDI-Device Identifier: 00827002084261
• UDI-Public: (01)00827002084261(17)230226(10)13012373
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 09/01/2020

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 Expiration Date: 02/26/2023
• Device Model Number: N/A
• Device Catalogue Number: NPAS-100-NT
• Device Lot Number: 13012373
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/14/2020
• Initial Date Received by Manufacturer: 07/14/2020
• Supplement Date Received by Manufacturer: 08/14/2020
• Initial Report FDA Received Date: 07/21/2020
• Supplement Report FDA Received Date: 09/01/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1