MAUDE Adverse Event Report: COOK INC HIWIRE HYDROPHILIC WIRE GUIDE; DQX WIRE, GUIDE, CATHETER

Catalog Number HW-35-150

Device Problem Flaked (1246)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Type  malfunction  

Manufacturer Narrative

Product code = dqx.This report includes information known at this time.A follow-up report will be submitted should additional relevant information become available.

Event Description

On (b)(6) 2018 it was reported the "wire hydrophilic tends to damaged when passed" and that this has happened multiple times "over the last 3 months." during percutaneous nephrolithotomy (pcnl) procedure the hydrophilic coating on the hiwire hydrophilic wire guide tends to become damaged when passed through the puncture needle.The flexible end allegedly becomes damaged resulting in the inability of the wire being used properly.Event dates are unknown.Additional information was requested in order to clarify the specific damage to the wire.The requested information was received (b)(6) 2019 reporting the wire "tends to strip off when it encounters resistance".It was reported that the coating was activated using normal saline prior to insertion into the patient's anatomy and intermittently throughout the procedures.Both ureteric orifice and nephrostomy puncture sites were used.It is unclear if latex or powdered gloves were used.Additional information stated that "a few of our patients required higher antibiotics due to prolonged procedure." patient anatomy has been described as normal.No patient adverse effects have been reported as a result of these events.Per the complainant, the complaint devices are not available for return to the manufacturer to aid in the investigation.Please reference medwatch 1820334-2019-00070 for the singular event that was initially reported.Additional information regarding event details has been requested, but is not available at this time.

Event Description

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

Manufacturer Narrative

A review of our documentation as well as the supplier¿s investigation was 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.There is no evidence to suggest the product was not made to specifications.A the cook lot number of the device is not known; accordingly, a review of the device history record could not be conducted.However, cook¿s supplier for this device, lake region medical reviewed their manufacturing, inspecting, and packaging records and provided the following report: "the history records indicate this product was final inspection tested at lake region medical and was determined to be acceptable.A review of the manufacturing and packaging processes indicates the operators are instructed to 100% visually inspect the general appearance of the hydrophilic coated wires for any obvious defects prior to shipment during manufacturing and packaging of this product.During the manufacture of this product, the operators perform a 100% tactile examination of each wire while the hydrophilic coated wires are wet, which includes an inspection that would detect inconsistencies in the coating.The operators also perform lot release testing on each lot of product including a lubricity test, which measures insertion and withdrawal loads.The investigation concluded that the product met specification at the time of shipment.As noted in the device instructions for use (dfu), prior to use, inspect for damage.If damaged, do not use.¿ in addition the device instructions for use (dfu) also states, ¿if movement of the wire within the device becomes diminished, remove the wire guide and reactivate the hydrophilic coating by wetting its entire surface with heparinized saline solution.¿ as indicated in the device instructions for use cautions, ¿avoid manipulating the hydrophilic wire guide back through a metal cannula/needle.A sharp edge may scrape the coating or shear the wire guide.A catheter, introducer sheath or vessel dilator should replace the needle as soon as the wire guide has been inserted in the vessel.¿ our investigation was unable to confirm that the product did not meet specification prior to shipment.The complaint is non-verifiable as the product was not returned for evaluation.At this time it is not possible to assign a definitive root cause for the event as reported.¿ based on the information provided, no product returned, the results of our investigation as well as the supplier¿s investigation, a definitive root cause could not be established.We will continue our monitoring of similar complaints and have notified the appropriate personnel of this event.Per the quality engineering risk assessment no further action is required.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.

• Brand Name: HIWIRE HYDROPHILIC WIRE GUIDE
• Type of Device: DQX WIRE, GUIDE, CATHETER
• Manufacturer (Section D): COOK INC; 750 daniels way; bloomington IN 47404
• MDR Report Key: 8258387
• MDR Text Key: 133527939
• Report Number: 1820334-2019-00074
• Device Sequence Number: 1
• Product Code: DQX
• Combination Product (y/n): N
• PMA/PMN Number: K000011
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,distri
• Type of Report: Initial,Followup
• Report Date: 02/12/2019

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
• Device Operator: Health Professional
• Device Expiration Date: 11/19/2020
• Device Catalogue Number: HW-35-150
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 01/02/2019
• Initial Date FDA Received: 01/17/2019
• Supplement Dates Manufacturer Received: 01/02/2019
• Supplement Dates FDA Received: 02/12/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1