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

Model Number	G30475
Medical Device Problem Code	Peeled/Delaminated (1454)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/29/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
E1: customer (person) postal code: (b)(6).H3: no evaluation code desc: other: device has been returned and preliminary evaluation has been performed, however, our investigation is ongoing and device evaluation summary will be included in our follow up report once our investigation has been completed.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 or Problem Description
It was reported that the coating of the hiwire nitinol hydrophilic wire guide was delaminated during device failure analysis (dfa) conducted for another failure mode for the same device.The tip of the product protector (pp) was bent during an unknown procedure, which was the initial complaint.After lubricating the pp, the wire was easily removed and examined.It was found that the black plastic coating was scraped off at approximately 31.5 cm from the protruding tip, suggesting that the wire might have been pulled before lubrication, causing the bend and scraping.The procedure was completed using another hiwire.As reported, the patient did not require any additional procedures due to this occurrence.The patient did not experience any adverse effects due to this occurrence.The device did not make patient contact.
Additional Manufacturer Narrative
Correction: d3/g1 (email), h3 investigation ¿ evaluation it was reported that the coating of the hiwire nitinol hydrophilic wire guide was delaminated during device failure analysis (dfa) conducted for another failure mode for the same device.The tip of the product protector (pp) was bent during an unknown procedure, which was the initial complaint.After lubricating the pp, the wire was easily removed and examined.It was found that the black plastic coating was scraped off at approximately 31.5 cm from the protruding tip, suggesting that the wire might have been pulled before lubrication, causing the bend and scraping.The procedure was completed using another hiwire.As reported, the patient did not require any additional procedures due to this occurrence.The patient did not experience any adverse effects due to this occurrence.The device did not make patient contact.The complaint device is assembled by a supplier to cook who carried out an investigation in addition to cook.Reviews of the complaint history, device history record (dhr), instructions for use (ifu), manufacturer¿s instructions (mi), and quality control (qc) procedures were conducted during the investigation.Functional tests and visual inspection of the returned complaint device was also conducted.One hiwire nitinol hydrophilic wire guide was returned for investigation in an open package with label.The tip protruding from the product protector was observed to be bent.After flushing the product protector, the wire guide was removed easily and was examined.The black jackets were observed to be scraped off the wire at approximately 31.5 cm from the protruding tip, indicating that the wire had been possibly pulled prior to lubrication which could have caused the bend and damage to the wire guide jacket.A review of the device master record (dmr) concluded that sufficient inspection activities are in place to identify this failure mode prior to distribution.A review of the device history record (dhr) was completed.The wire guide is assembled and packaged by a supplier who completed a dhr review.The incoming inspection records at cook were reviewed and the lot passed incoming inspection.A review of the dhr did not present any indication of manufacturing defect or anomaly that could have impacted on the event as reported.A complaint history database search showed one other related complaint for the failure mode attributed to the complaint device lot.The evidence from the complaint file, device history record, complaint history and the supplier investigation indicate that the complaint device was manufactured to specification as well as other items in the lot or similar devices in the field or in house.Cook also reviewed product labeling; the ifu supplied with the device states the following in consideration of the reported failure mode: 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 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.The wire guide is assembled and packaged by a supplier who noted the wire guide presented skived/cut damage, exposing the metallic core wire.The supplier concluded based on the nature of the skived/cut damage, it appears that the wire guide was not properly hydrated prior to removal from the dispenser hoop.This in combination with excessive manipulation of the wire guide while attempting to remove the wire guide from the dispenser hoop can result in bend damage.Based upon the available information, inspection of the returned device, and results of the investigation, cook has concluded that the cause for the complaint could not be established but is not ruling out handling the wire guide in preparation for the procedure.The appropriate personnel have been notified.Cook will continue to monitor for similar events.Per the quality engineering risk assessment, no further action is required.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 or Problem Description
No additional information regarding the patient and/or event has been received since the previous medwatch report was sent.

• 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
• Manufacturer (Section G): COOK INC.; 750 daniels way; bloomington IN 47404
• Manufacturer Contact: jason crouch ; 750 daniels way; bloomington, IN 47404 ; 8123392235
• MDR Report Key: 20906451
• Report Number: 1820334-2024-01632
• Device Sequence Number: 11818040
• Product Code: OCY
• UDI-Device Identifier: 00827002304758
• UDI-Public: (01)00827002304758(17)260109(10)71003334
• Combination Product (Y/N): N
• PMA/510(K) Number: K082536
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Distributor
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 06/17/2025

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: 01/09/2026
• Device Model Number: G30475
• Device Catalogue Number: HWAS-035150
• Device Lot Number: 71003334
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/20/2024
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 11/20/2024
• Supplement Date Received by Manufacturer: 05/30/2025
• Initial Report FDA Received Date: 12/11/2024
• Supplement Report FDA Received Date: 06/17/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/10/2023
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown