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

Model Number N/A

Device Problems Material Separation (1562); Unraveled Material (1664)

Patient Problem No Code Available (3191)

Event Date 09/19/2018

Event Type  Injury  

Manufacturer Narrative

Initial reporter occupation: unknown.Pma/510(k) #: exempt.(b)(4).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 a female patient required placement of a neff percutaneous access set for drainage of an "inter-vesico-uterine hematoma" 15 days post caesarean section.The operator reported that "the end of the metal guide of the drain ruptured in the inter-vesico-uterine region and could not be recovered." the fragment was left in the patient which caused persistent pain to the patient.An unknown time later, the "metal part" was removed during a laparoscopic procedure and "the pain is then clearly reduced." photos of the device provided by the customer reveal the device had unraveled.No other adverse effects were reported for this incident.

Manufacturer Narrative

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

The fragment was removed on (b)(6) 2019.

Manufacturer Narrative

Blank fields on this form indicate the information is unchanged, unknown or unavailable.Additional methods code: communication/interviews (4111).Investigation ¿ evaluation.C.H.U de nimes informed cook of an incident involving a neff percutaneous access set.On (b)(6) 2018 during a procedure for access for drainage the tip of the wire guide broke off into the patient.The patient experienced pain due the fragment left inside.On (b)(6) 2019 the fragment was removed during a laparoscopic procedure.After removal of the fragment the pain reduced.The complainant did not return the complaint device to cook for investigation.However, the customer provided images of the wire guide that failed.The guide is separated and unraveled throughout the device.The mandril is broken and there appears to maybe be glue on the end of the wire guide.From the image cook is unable to tell if the weld ball is intact.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.A review of the device history record (dhr) was unable to be completed due to lack of lot information from the user facility.A european sales shipment report was conducted and the lot was unable to be narrowed down.Due to missing information, there is no evidence suggesting nonconforming product from the affected lot exists in house or in the field.Cook could not review the product¿s instructions for use (ifu) for the reported failure mode because no ifu exists for a neff percutaneous access set.The customer reported the tip of the wire guide broke off into the patient.Findings of this investigation revealed no evidence to suggest the device was manufactured out of specification.Some factors that can cause separation of the wire guide include the wire guide tip caught on the introducing needle which can result in damage to the wire guide.The patient¿s anatomy may make withdrawal or manipulation of the wire guide difficult which can also result in damage.When the wire guide is manufactured the wire guide is checked 100% before released.Based on the information provided, examination of photos provided by the user, and the results of the investigation it was concluded that a component failure without a manufacturing or design defect contributed to this event.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 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
• MDR Report Key: 9559635
• MDR Text Key: 188481094
• Report Number: 1820334-2020-00076
• Device Sequence Number: 1
• Product Code: KGZ
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup,Followup
• Report Date: 03/26/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/07/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: NPAS-105-RH-NT-U
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 03/25/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention