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

Model Number	N/A
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	06/11/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Concomitant medical products: boston accustick.Occupation: unknown.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 placement of a neff percutaneous access set for a 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".A second wire was used, and the operator experienced the same difficulty.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 effects were reported for this incident.
Event or Problem Description
It was originally reported that two devices were felt resistant and scratchy on manipulating and appeared "damaged" on removal.A third device was reported to have separated in the patient.The products were returned on (b)(6) 2020 and showed separation of two wires.Examination of the third wire showed no malfunction.The first wire that separated is reported under medwatch report number: 1820334-2020-01335.The second wire that separated with a portion retained in the patient is reported under medwatch report number: 1820334-2020-01157 (this report).
Additional Manufacturer Narrative
Concomitant products: no concomitant products provided by customer.This report includes information known at this time.A follow up report will be submitted should additional relevant information become available.This report is required by the fda under 21 cfr part 803.This report is based on unconfirmed information submitted by others.Neither the submission of this report nor any statement made in it is intended to be an admission that any cook device is defective or malfunctioned; that a death or serious injury occurred; or that any cook device caused or contributed to; or is likely to cause or contribute to a death or serious injury if a malfunction occurred.
Additional Manufacturer Narrative
Blank fields on this form indicate the information is unchanged, unknown or unavailable.D10 ¿ product received on: 14jul2020.Additional methods code: analysis of production records (3331).Additional information: section c - suspect product(s).Investigation ¿ evaluation.A representative from (b)(6) hospital informed cook of three incidents involving a neff percutaneous access set.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.For all three sets, cook is interpreting the response from the user that the user knows not to manipulate the wire through the needle.Upon return of the three complaint wire guides, one was returned kinked and two were returned separated.Three complaints were opened to capture these failures.This report is for the wire guide separated with a portion left in 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 device showed 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.For the kinked wire guide, the kink measures at 3.5cm from the distal end with multiple off-set coils.All trocar stylets were inserted and 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 pmg-18sp 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.At the time of the investigation, the returned devices suggest no evidence that the device was manufactured out of specification.Additionally, a document based investigation evaluation was performed.The risks associated with these devices are acceptable when weighed against the benefits.Sufficient inspection activities are in place to identify this failure mode prior to distribution.The device history record (dhr) for the complaint lot, the wire guide subassembly lot and the needle sub-assembly and raw material lots revealed no related non-conformances.A database search was completed on the complaint lot and two additional complaints were found.These complaints were reported at the same time from the same user facility for the same failure.One complaint is for the wire guide kinked.The other complaint is for the wire guide separated with no portion left in the patient.The wire guide tip could have been caught on the introducing needle which can result in damage to the wire guide.However, cook is interpreting the response from the user to mean that the user knows not to manipulate the wire through the needle.When the wire guide is manufactured the wire guide is checked 100% before released and no related non-conformances 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, inspection of returned product and the results of the investigation, it was concluded an adverse event related to procedure contributed to this incident.The appropriate personnel have been notified.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.
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: 10174932
• Report Number: 1820334-2020-01157
• Device Sequence Number: 13915321
• 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,Followup
• Report Date (Section B): 08/14/2020

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: 06/12/2020
• Supplement Date Received by Manufacturer: 07/14/2020; 08/14/2020
• Initial Report FDA Received Date: 06/19/2020
• Supplement Report FDA Received Date: 07/27/2020; 08/14/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: SEE H10
• Outcome Attributed to Adverse Event: Other