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

Model Number	G30473
Medical Device Problem Code	Peeled/Delaminated (1454)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	03/20/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Occupation: other non-healthcare professional: analyst.This report includes information known at this time.A follow up report will be submitted should additional relevant information become available.
Event or Problem Description
It was reported, during a flexible laser ureterolitotripsy using a hiwire nitinol hydrophilic wire guide, the hydrophilic came off the device.The wire guide was first activated by placing in sterile saline.As the user was maneuvering the guide wire through the working channel of the scope, the hydrophilic coating was being removed.No part of the device remained inside the patient.They replaced with another similar type device from another manufacturer to complete the procedure.According to the initial reported, there were no adverse effects reported due to the alleged malfunction.
Additional Manufacturer Narrative
Blank fields on this form indicate the information is unknown, unchanged, or unavailable.Ec methods code desc - 5: communication/interviews (4111) investigation ¿ evaluation it was reported, during flexible laser ureterolithotripsy, when inserting a hiwire nitinol hydrophilic wire guide through the working channel of the rigid ureteroscope, the hydrophilic cover is coming off.A different type hydrophilic wire guide was used to proceed with the procedure.A visual inspection, dimensional verification, 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, quality control data, and specifications.One device was returned for investigation.Visual examination confirmed the open wire guide was received in used condition.Wire guide was returned without the protective coil.Wire guide is lumpy and shows evidence of hydration.Distal end of the wire jacket is peeling approximately 3.5cm from the flexible tip.Supplier investigation summary: dimensional verification: the specimen presented an overall length of 150.35cm and a finished diameter of.03515¿ to.03700¿.A gage bushing certified to be.0380¿ passed over the length of the specimen with no more effort than the mass of the bushing sliding down the wire shaft unaided, except by gravity.Note all diameter measurements were acquired with a non-contact, toolmakers scope after allowing the specimen device to become dry after hydrating the specimen device with blood-bank saline.Observation findings: after wetting the specimen with blood-bank saline, the specimen w subjected to visual and tactile examination.The specimen coating appeared visually and tactilely consistent when examined at 1x ¿18 inches, unaided, wet.The specimen presented surface wear and abrasion consistent with clinical use.The specimen did not present any indication of ¿the hydrophilic cover leaves the material¿.Except where noted, the specimen device appeared visually and dimensionally correct.Summary of findings: a review of the device history records of the specimen device does not present any indication of manufacturing defect or anomaly that could have impacted on the event as reported.During manufacturing the production operators are instructed to 100% visually and tactilely inspect for any obvious defect, which includes a tactile examination of the entire length of each wire.In addition, during packaging of this product the operators are instructed to 100% visually inspect for any obvious defect prior to shipment.The history records indicate this product was final inspection tested at lake region medical and was determined to be acceptable.As noted above, the specimen presented surface wear and abrasion consistent with clinical use.The specimen did not present any indication of ¿the hydrophilic cover leaves the material¿.The hydrophilic coating on this product is a transparent polymer coating that does expand when hydrated; however, any pressure (point or broad surface) on the hydrated coating will immediately displace the hydrating fluid in accordance to the amount of pressure applied.Our investigation was unable to confirm that the product did not meet specification prior to shipment.The investigation concluded that the product met specification at the time of shipment.At this time, it is not possible confirm the complaint as reported or 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 a review of the device history record found no non-conformances related to the reported failure mode.A trackwise search revealed one additional complaints associated with lot 11160106.Complaint (b)(6) was initiated by the same customer for the same failure mode.Due to the individual inspection of these devices at the supplier, one nonconformance in the lot is not indicative of the entire lot.In response to this event, cook has reviewed the instructions for use for this device.The following information is provided in the use of the device: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.A review of relevant manufacturing documents was conducted.It was concluded that the device aspect in question was visually/functionally inspected by quality control and no related gaps in production or processing controls were noted.It is not possible to assign a definitive root cause for this event.Per the quality engineering risk assessment, no further action is warranted.Cook 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.
Event or Problem Description
No new patient or event information to report.

• Brand Name: HIWIRE NITINOL HYDROPHILIC WIRE GUIDE
• Common Device Name: OCY ENDOSCOPIC GUIDEWIRE, GASTROENTEROLOGY-UROLOGY
• Manufacturer (Section D): COOK INC; 750 daniels way; bloomington IN 47404
• MDR Report Key: 9928065
• Report Number: 1820334-2020-00751
• Device Sequence Number: 2827159
• Product Code: OCY
• UDI-Device Identifier: 00827002304734
• UDI-Public: (01)00827002304734(17)220723(10)11160106
• Combination Product (Y/N): N
• PMA/510(K) Number: K082536
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: distributor,foreign,other,use
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 06/01/2020

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
• Operator of Device: Health Professional
• Device Expiration Date: 07/23/2022
• Device Model Number: G30473
• Device Catalogue Number: HW-038150
• Device Lot Number: 11160106
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/30/2020
• Initial Date Received by Manufacturer: 03/27/2020
• Supplement Date Received by Manufacturer: 05/27/2020
• Initial Report FDA Received Date: 04/06/2020
• Supplement Report FDA Received Date: 06/01/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1