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

Model Number	N/A
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
E1: customer zip code = (b)(6).E3: customer occupation = materials manager.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, 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
As reported, the tip of a 'hiwire nitinol hydrophilic wire guide' broke off as the device was being removed from the package, prior to the procedure; there was no patient contact.A section of the device did not remain inside the patient¿s body.The patient did not require any additional intervention due to this occurrence.The patient did not experience any adverse effects due to this occurrence.Additional information regarding wire guide coating activation and how the procedure was completed has been requested but is not available at this time.
Additional Manufacturer Narrative
Blank fields on this form indicate the information is unknown, unchanged, or unavailable.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, 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
Additional information received 14sep2023: the coating of the wire guide was activated with sterile water.The procedure was completed with another device.
Event or Problem Description
No additional information regarding the patient and/or event has been received since the previous medwatch report was sent.
Additional Manufacturer Narrative
Blank fields on this form indicate the information is unknown, unavailable, or unchanged.Event summary as reported, the tip of a 'hiwire nitinol hydrophilic wire guide' broke off as the device was being removed from the package, prior to the procedure; there was no patient contact.The coating of the wire guide was activated with sterile water.The procedure was completed with another device.The patient did not experience any adverse effects due to this occurrence.Investigation ¿ evaluation a document-based investigation was performed including a review of complaint history, device history record (dhr), instructions for use (ifu), and quality control procedures, as well as a visual inspection of the device were conducted.One used hiwire nitinol hydrophilic wire guide was returned to cook for investigation.The wire guide was returned with the product packaging indicating it was from lot 71002941.The returned complaint device was reviewed by the supplier who noted the specimen presented a ductile/tensile overload fracture of the polymer jacket with material removal, exposing the distal 0.6 cm of the metallic core wire.The polymer jacket material distal of the fracture was not returned with the specimen.Except where noted, the specimen device appeared visually and dimensionally correct.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 dhr for the reported complaint device lot revealed no recorded non-conformances relevant to the failure mode.A database search did not identify any other events associated with the reported device lot.Based on the available information, cook has concluded that there is no evidence suggesting nonconforming product exists either in house or in field.The evidence from the complaint file, device history record, complaint history and the supplier evaluation of the complaint device indicates 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.The instructions for use state, ¿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 complaint device was assembled by a supplier to cook who carried out an investigation in addition to cook.The complaint was confirmed based on the customer testimony and returned complaint device.Cook has concluded a cause for the complaint cannot be established, it's not possible to rule out handling factors.The appropriate personnel have been notified.Cook will continue to monitor for similar complaints.Per the 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.

• 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: 17514655
• Report Number: 1820334-2023-01077
• Device Sequence Number: 5460169
• Product Code: OCY
• UDI-Device Identifier: 00827002304765
• UDI-Public: (01)00827002304765(17)250801(10)71002941
• 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: Other,Foreign,User Facility,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 11/07/2023

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: 08/01/2025
• Device Model Number: N/A
• Device Catalogue Number: HW-035150
• Device Lot Number: 71002941
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 07/24/2023
• Supplement Date Received by Manufacturer: 09/14/2023; 10/16/2023
• Initial Report FDA Received Date: 08/11/2023
• Supplement Report FDA Received Date: 10/10/2023; 11/07/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/02/2022
• 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