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

Model Number N/A

Device Problems Break (1069); Unraveled Material (1664)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 07/12/2022

Event Type  malfunction  

Manufacturer Narrative

Blank fields on this form indicate the information is unknown or unavailable.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.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.

Event Description

It was reported that the wire guide included in the neff percutaneous access set was "broken" during an rtcd procedure on a 73 year-old female patient.An additional wire guide that was opened as a replacement also "broke" during the procedure.The wire guide was then removed and another device was opened to complete the procedure successfully.The patient did not experience any adverse effects due to this occurrence.Additional information regarding event details has been requested, but is currently unavailable.This report captures the first instance of wire guide breakage.The second occurrence of wire breakage has been referenced in the report with patient identifier: (b)(6).

Event Description

In additional information provided on 21sep2022, it was confirmed by the distributor that the second wire was fractured in the same way as the first wire guide.On 23sep2022, the distributor later reported that two cook wires were used in the procedure.The device with lot #: 14141571 (captured in this event) was lost by the nurse and will not be returned.Only one device (captured in mfg, report reference #: 1820334-2022-01390) has been received by the manufacturer.The returned black wire is a competitor wire; however, no additional information on the wire could be provided by the facility.

Manufacturer Narrative

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.

Manufacturer Narrative

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.

Event Description

Additional information was provided on 26aug2022.The procedure was a percutaneous transhepatic cholangio drain placement for advanced intrahepatic cholangiocarcinoma.The puncture needle was inserted into the bile duct and the wire was advance to the target location.The needle was then withdrawn.The "grey soft catheter" passed the tip of the wire into the bile duct, as noted in fluoroscopy imaging, when the wire guide "broke" in the patient.The user felt "the support force weakened" and suspected the wire fractured.The wire and soft catheter were removed together, and the wire was noted to be "broken" in the catheter.No further information has been provided related to the second wire that "broke" during the procedure (captured in medwatch report #:1820334-2022-01390).Two cook wire guides were returned in association with this incident.One wire was unraveled and the other was undamaged.A third, unknown manufacturer wire was also returned unraveled.

Manufacturer Narrative

Heshuo medical technology co., ltd.(china) contacted cook on 16aug2022 concerning a neff percutaneous access set (rpn: npas-100-rh-nt; lot# 14141571).The customer stated that during a ptcd procedure on (b)(6) 2022, the wire guide broke when introducing the catheter.The wire guide was not withdrawn or manipulated through the needle.The second wire guide used also broke (medwatch ref # 1820334-2022-01390).The procedure was completed with another new device.No part of the product remained within the patient.The patient did not require any additional procedures nor experience any adverse effects due to this occurrence.Reviews of the complaint history, device history record (dhr), manufacturing instructions, and quality control procedures for the device, were conducted during the investigation.The complaint device was not returned; therefore, no physical examinations could be performed.However, a document-based investigation evaluation was performed.In response to this incident, cook completed a review of the product device master record (dmr) and concluded that sufficient inspection activities are in place to identify this failure mode prior to distribution.Cook also reviewed the device history record (dhr).The dhr for lot# 14141571 and all related sub assembly lots records no relevant non-conformances.A database search for complaints on the reported lot found no additional complaints reported from the field.Based on the available information, cook was not able to determine the product was manufactured out of specification.There is no evidence of non-conforming material in house or in the field.This product is not supplied with an instructions for use (ifu) pamphlet.Based on the information provided, no returned device and the results of the investigation, cook has concluded that component failure unrelated to manufacturing or design deficiencies contributed to the event.The appropriate personnel have been notified.Cook will continue to monitor for similar complaints.Per the 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 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
• Type of Device: KGZ ACCESSORIES, CATHETER
• Manufacturer (Section D): COOK INC; 750 daniels way; bloomington IN 47404
• Manufacturer (Section G): COOK INC; 750 daniels way; bloomington IN 47404
• Manufacturer Contact: jason crouch ; 750 daniels way; bloomington, IN 47404 ; 8123392235
• MDR Report Key: 15282628
• MDR Text Key: 305502489
• Report Number: 1820334-2022-01389
• Device Sequence Number: 1
• Product Code: KGZ
• UDI-Device Identifier: 00827002105447
• UDI-Public: (01)00827002105447(17)240806(10)14141571
• Combination Product (y/n): N
• Reporter Country Code: CH
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,User Facility,Distributor
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 03/06/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/24/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: NPAS-100-RH-NT
• Device Lot Number: 14141571
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 02/16/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/06/2021
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Age: 73 YR
• Patient Sex: Female