MAUDE Adverse Event Report: COOK INC HIWIRE NITINOL HYDROPHILIC WIRE GUIDE; OCY ENDOSCOPIC GUIDEWIRE, GASTROENTEROLOGY-UROLOGY

Model Number G30474

Device Problem Peeled/Delaminated (1454)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 12/01/2019

Event Type  malfunction  

Manufacturer Narrative

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 prior to the beginning of a ureteroscopy, the hiwire nitinol hydrophilic wire guide was found to be "dry and not slippery".The operator thought the coating was separating from the guidewire at "first contact." it is unknown how the procedure was completed.A section of the device did not remain inside the patient¿s body.The patient did not require any additional procedures due to this occurrence.According to the initial reporter, the patient did not experience any adverse effects due to this occurrence.Additional information has been requested and a follow-up report will be submitted when and if that information is received.

Event Description

No new patient or event information since the last report was submitted.

Manufacturer Narrative

Ec method code desc - 5: communication/interviews (4111).Investigation evaluation: a visual inspection and functional testing of the returned device was conducted.A document based investigation was also performed including a review of complaint history, device history record, the instructions for use, manufacturing instructions, specifications, and quality control data.The complainant returned one open package and four hundred twenty five unopen packages each containing a hiwire nitinol hydrophilic wire guide for investigation.Visual examination confirmed the open wire guide was received in prior to use condition.The holder was dry and showed no signs of hydration.The wire guide was protruding from the coiled holder by approximately 20.5cm.A review of the device history record found no non-conformances related to the reported failure mode.A review of complaint history records shows no other complaints associated with the complaint device lot.The instructions for use (ifu), provides the following information to the user related to the reported failure mode: precautions: manipulation of wire guide requires appropriate imaging control.Use caution not to force or over manipulate the wire guides when gaining access.When using wire guide through a metal cannula /needle, use caution as damage may occur to outer coating.When exchanging or withdrawing an instrument over the wire guide, secure and maintain the wire guide in place under fluoroscopy in order to avoid unexpected wire guide displacement.These wire guides are not intended for tpca use.Instructions for activating hydrophilic coating: the hydrophilic coating on the wire guide is activated by immersion in sterile water or sterile saline solution.1.Prior to using the wire guide, fill a syringe with sterile water or sterile saline solution and attach it to the flushing port on the wire guide.2.Inject enough solution to wet the wire guide surface entirely.This will activate the hydrophilic coating.Hydrophilic coated wires are very slippery when wet.Always maintain control of the wire guide when manipulating it through any device.For optimal performance, rehydrate the hydrophilic coated wire guide after exposure to ambient environment or after extended use, replace it with a new hydrophilic coated wire guide.How supplied: upon removal from the package, inspect the product to ensure no damage has occurred.The open device was returned to the supplier for investigation and 30 devices were archived and the remaining 395 have been destroyed.The investigation concluded that the product met specification at the time of shipment.At this time, it is not possible to assign a definitive root cause for the event as reported.Based on the information provided and the evidence presented, it appeared that clinical and/or procedural factors have contributed to the event as reported.The returned device showed evidence of a scrape on the surface of the coating.The cause of the scrape could not be determined as the device was returned in an opened condition.It is possible the device was scrapped during use, or from a manufacturing error.The lot number of the returned device is associated with a coating parameter being on the low end of specification during manufacturing at the supplier's facility from 15mar2019 to 15jun2019.Per the quality engineering risk assessment, no further action is warranted.Cook medical will continue to monitor this device via the complaints database for similar complaints.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 NITINOL HYDROPHILIC WIRE GUIDE
• Type of Device: OCY ENDOSCOPIC GUIDEWIRE, GASTROENTEROLOGY-UROLOGY
• Manufacturer (Section D): COOK INC; 750 daniels way; bloomington IN 47404
• MDR Report Key: 9439389
• MDR Text Key: 175750262
• Report Number: 1820334-2019-03051
• Device Sequence Number: 1
• Product Code: OCY
• UDI-Device Identifier: 00827002304741
• UDI-Public: (01)00827002304741(17)220528(10)11144422
• Combination Product (y/n): N
• PMA/PMN Number: K082536
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 02/04/2020

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
• Device Operator: Health Professional
• Device Expiration Date: 05/28/2022
• Device Model Number: G30474
• Device Catalogue Number: HWS-035150
• Device Lot Number: 11144422
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/07/2020
• Initial Date Manufacturer Received: 12/01/2019
• Initial Date FDA Received: 12/09/2019
• Supplement Dates Manufacturer Received: 02/03/2020
• Supplement Dates FDA Received: 02/04/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1