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

Model Number N/A

Device Problem Detachment of Device or Device Component (2907)

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

Event Date 09/09/2021

Event Type  malfunction  

Manufacturer Narrative

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 Description

It was reported that the hub of a neff percutaneous access set separated from the external cannula during a nephrostomy procedure.As a result, another same-model device was used.No adverse effects to the patient have been reported.Additional information regarding the patient, device, and event has been requested but is currently unavailable.

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 on27oct2021.The separation was confirmed to be at the hub of the sheath.The separation occurred at the beginning of the procedure, during the insertion in the renal pelvis.The patient did not have tortuous or abnormal anatomy.

Event Description

No additional information regarding the patient and/or event has been received since the previous medwatch report was sent.

Manufacturer Narrative

Investigation ¿ evaluation: asst ovest milanese in italy informed cook of an issue with a npas-100-nt (neff percutaneous access set) from lot 14018605.The customer stated the neff hub detached from the external cannula (sheath).The separation occurred at the beginning of the procedure.A section of the device did not remain in the patient.No additional procedures were required.The procedure was completed with a replacement device.The patient did not experience any adverse effects.A review of the complaint history, device history record, instructions for use (ifu), and quality control were conducted during the investigation.The customer did not return the device for evaluation.A device failure analysis could not be completed.However, a document based investigation evaluation was performed.There are sufficient controls in place to detect damage prior to distribution.Cook also reviewed product labeling.This device is not packaged with instructions for use.Cook reviewed the device history record.There are no nonconformances for lot 14018605.There are no related non-conformances for the three related sheath subassembly lots.A database search revealed one other complaint from lot 14018605 for the same failure mode at the time of investigation (reported under medwatch report #: 1820334-2021-02219).This complaint was reported from the same user facility.Additional final lots containing the same sheath subassembly lots were reviewed.Seven lots were found.No additional complaints or related nonconformances were noted from these lots.Based on this information, it is feasible to suggest that non-manufacturing-related factors contributed to the event.Considering this information, there is no evidence that nonconforming product exists in house or in the field.Based on the device master record and device history record, there is no indication the complaint device was manufactured out of specification.It is possible there was difficulty during insertion.This could have led to excessive force being used when attempting to withdraw the device, causing the hub to detach.However, the customer reported that the patient did not have tortuous/difficult anatomy, so this cannot be confirmed with certainty.Based on the information provided and the results of the investigation, it was concluded that component failure unrelated to manufacturing or design deficiencies contributed to the event.The appropriate personnel have been notified.Per the 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: 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: 12528862
• MDR Text Key: 273450877
• Report Number: 1820334-2021-02218
• Device Sequence Number: 1
• Product Code: KGZ
• UDI-Device Identifier: 00827002084261
• UDI-Public: (01)00827002084261(17)240610(10)14018605
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Health Professional,User Facility,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 12/22/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/24/2021
• 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-NT
• Device Lot Number: 14018605
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/22/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/10/2021
• 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 Sex: Male