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

Model Number N/A

Device Problems Break (1069); Material Separation (1562); Unraveled Material (1664)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 08/28/2023

Event Type  malfunction  

Event Description

It was reported that a roadrunner nimble hydrophilic wire guide was found to be broken prior to use.A customer provided photo shows separation of the wire tip from the wire guide.The device did not make patient contact.A new same device from same lot was used to complete the procedure.As reported, the patient did not experience any adverse effects or require any additional procedures due to this occurrence.

Manufacturer Narrative

Blank fields on this form indicate the information is unknown or unavailable.E1- customer (person): (b)(6).H3: 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 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 or that a death or serious injury occurred; nor is it admission 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 Description

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

Manufacturer Narrative

Event description: it was reported that a roadrunner nimble hydrophilic wire guide was found to be broken prior to use.A customer provided photo shows separation of the wire tip from the wire guide.The device did not make patient contact.A new same device from same lot was used to complete the procedure.As reported, the patient did not experience any adverse effects or require any additional procedures due to this occurrence.Investigation ¿ evaluation a visual inspection of the returned device was conducted.A document-based investigation was also performed including a review of complaint history, device history record (dhr), the instructions for use (ifu), and quality control procedures.One roadrunner nimble hydrophilic wire guide was returned in an opened labelled package.The flexible tip was separated from the rest of the wire guide and the coiling wire was partially unraveled.No other damage noticed.A document-based investigation evaluation was performed.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 found no non-conformances related to the reported failure mode.A review of complaint history records shows one other related complaint associated with the complaint device lot.There are 100% inspections in place to ensure the surface of the wire guide is smooth and not damaged.Therefore, it is unlikely this issue affects the entire lot.Based on the available information, cook has concluded that the device was manufactured to specification and there is no evidence suggesting nonconforming product exists either in house or in the field.The instructions for use (ifu), provides the following information to the user related to 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 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 customer reported finding the damage after opening the packaging.A cause for the complaint could not be established.Per the quality engineering risk assessment, no further action is required.The appropriate personnel have been notified, and we will continue to monitor 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: ROADRUNNER NIMBLE HYDROPHILIC WIRE GUIDE
• Type of Device: 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: 17799655
• MDR Text Key: 324050992
• Report Number: 1820334-2023-01271
• Device Sequence Number: 1
• Product Code: OCY
• Combination Product (y/n): N
• PMA/PMN Number: K082536
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,User Facility,Distributor
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 12/05/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/22/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: RFSPC-035145-0-I-AQ
• Device Lot Number: 15210231
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/20/2023
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 11/06/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/06/2023
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Age: 53 YR
• Patient Sex: Female