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

Model Number	G30473
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	09/30/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(6).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 percutaneous nephrolithotomy, the surgeon discovered that the "cladding" on a hiwire nitinol hydrophilic wire guide was separating as it was advanced past the stone burden.The procedure was completed using a similar wire guide.No adverse effects to the patient were reported due to this incident.No portion of the device remained within the patient.
Additional Manufacturer Narrative
H6: communication/interviews (4111).Additional information: d10.Investigation evaluation: 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.The returned packaging confirms the reported complaint device lot number.Visual examination confirmed wire guide was received in used condition and without the coiled holder.Under magnification areas of scrape marks were visible on the wire coating.Supplier investigation found that the specimen presented a large radius bend over the distal 19.4cm; consistent with tensile loading, such as from withdrawal against resistance.The complaint is not confirmed as the specimen did not present any evidence that ¿the cladding on the wire was separating¿.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.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.The complaint is confirmed upon customer testimony and the returned complaint device displayed evidence of wear consistent with clinical use.The coating was not spontaneously separating from the wire guide.The supplier reviewed the device history record and was unable to find any evidence the wire was not manufactured to specifications prior to shipment.The customer most likely experienced the hydrophilic coating scraping against the stone during the procedure.Per the quality engineering risk assessment, no further action is warranted.Cook medical has notified the appropriate personnel and 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 additional patient or event information has been received since the last report was submitted on 03oct2019.

• 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: 9152541
• Report Number: 1820334-2019-02527
• Device Sequence Number: 14097346
• Product Code: OCY
• UDI-Device Identifier: 00827002304734
• UDI-Public: (01)00827002304734(17)220522(10)11150909
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: K082536
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 12/02/2019

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
• Operator of Device: Health Professional
• Device Expiration Date: 05/22/2022
• Device Model Number: G30473
• Device Catalogue Number: HW-038150
• Device Lot Number: 11150909
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/15/2019
• Initial Date Received by Manufacturer: 09/30/2019
• Supplement Date Received by Manufacturer: 11/26/2019
• Initial Report FDA Received Date: 10/03/2019
• Supplement Report FDA Received Date: 12/02/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1