MAUDE Adverse Event Report: COOK INC STANDARD FIXED CORE WIRE GUIDE; OCY ENDOSCOPIC GUIDEWIRE, GASTROENTEROLOGY-UROLOGY

Model Number G14589

Device Problem Unraveled Material (1664)

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

Event Date 08/24/2022

Event Type  malfunction  

Manufacturer Narrative

Blank fields on this form indicate the information is unknown or unavailable.Occupation = sterile processing 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 Description

As reported, during an unspecified procedure, the wire from a standard fixed core wire guide unraveled inside the patient.The device did not separate, and no portion of the device was left in the patient.The procedure was successfully completed, but details have not been confirmed on how it was completed.The patient did not require any additional procedures and did not experience any adverse effects due to this occurrence.Additional information regarding event details has been requested but is not available at this time.

Manufacturer Narrative

Blank fields on this form indicate the information is unknown, unavailable, or unchanged.Event summary as reported, during an unspecified procedure, the wire from a standard fixed core wire guide unraveled inside the patient.The device did not separate, and no portion of the device was left in the patient.The procedure was completed with the unraveled device.The patient did not require any additional procedures and did not experience any adverse effects due to this occurrence.Additional information: b5 investigation - evaluation reviews of the complaint history, device history record, and quality control procedures of the device were conducted during the investigation.No device was returned for investigation.A document-based investigation evaluation was performed.No related non-conformances were recorded, and there have been no other reported complaints for this lot number.The device history record review provides objective evidence that the device was manufactured to specification.There is no evidence of nonconforming devices from the complaint lot in house or in the field.A review of relevant manufacturing documents was conducted.It was concluded that the device aspect in question was functionally inspected by quality control and no notable gaps in production or processing controls were noted.There is no indication that a design or process related failure mode contributed to the reported event.Sufficient inspection activities are in place to identify this failure mode prior to distribution.Based on the available information, cook has concluded that a cause for this event could not be established.Cook will continue monitoring of similar complaints and has notified the appropriate personnel of this event.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 Description

Additional information received (b)(6) 2022.The procedure was completed with the unraveled device.

• Brand Name: STANDARD FIXED CORE 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: 15370068
• MDR Text Key: 305416929
• Report Number: 1820334-2022-01458
• Device Sequence Number: 1
• Product Code: OCY
• UDI-Device Identifier: 00827002145894
• UDI-Public: (01)00827002145894(17)241021(10)14297520
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K082536
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: User Facility,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 10/11/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/07/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: G14589
• Device Catalogue Number: 638497
• Device Lot Number: 14297520
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 09/16/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/21/2021
• 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