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

Model Number G30472

Device Problem Peeled/Delaminated (1454)

Patient Problems Insufficient Information (4580); No Clinical Signs, Symptoms or Conditions (4582)

Event Type  malfunction  

Manufacturer Narrative

Initial reporter name and address: name and address- postal code: (b)(6).Initial reporter occupation: occupation -operating room materials coordinator.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, the polymer jacket of a hiwire nitinol hydrophilic wire guide delaminated from the inner wire, bunching up on the wire and leaving parts of the inner wire exposed.Additional event and patient outcome information has been requested.

Manufacturer Narrative

Blank fields on this form indicate the information is unknown, unchanged, or unavailable.Summary of event: as reported, the polymer jacket of a hiwire nitinol hydrophilic wire guide delaminated from the inner wire, bunching up on the wire and leaving parts of the inner wire exposed.Additional information received 04nov2022: the user facility reported that the wire was not altered from its original condition prior to use.Both powder and latex gloves were worn during device use.The device was used one time.The wire flushed with saline prior to use.The user was not aware of any flaking on the wire.The reporter is unsure how the coating was activated, how long the coating was activated, or if the coating was reactivated before reuse.The reporter stated they are not aware of any unintended section of the device remaining inside the patients body, if the patient was hospitalized or had prolonged hospitalization, if the patient required any additional procedures, if there were any adverse effects on the patient, or if there were any surgical/medical interventions performed due to this occurrence.Investigation evaluation: reviews of the complaint history, device history record, instructions for use (ifu), and quality control procedures were conducted during the investigation.The complaint device was not returned to cook for investigation.A document-based investigation evaluation was performed.No related non-conformances were found, and there have been no other reported complaints for this lot number.The suppliers review of the device history record did not present any indication of manufacturing defect or anomaly that could have impacted on the event as reported.The history records indicate this product was final inspection tested and was determined to be acceptable.The supplier was unable to determine a definitive root cause for the event reported.The product ifu provides the follow 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.The information provided upon review of the complaint file, device history record, complaint history and supplier investigation suggests that there is evidence the device was manufactured to specification.There is no evidence of non-conforming devices in-house or in the field.Cook has concluded that sufficient inspection activities are in place to identify this failure mode prior to distribution.Based on the information provided and the results of the investigation, cook was unable to determine a definitive cause for this event.The risk analysis for this failure mode was reviewed and no additional escalation was required.The appropriate personnel have been notified and cook will continue to monitor for similar events.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

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

Manufacturer Narrative

Additional/corrected information - b3: september 2022, b5, h6 (annex e and f) 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

Additional information received 04nov2022: the user facility reported that the wire was not altered from its original condition prior to use.Both powder and latex gloves were worn during device use.The device was used one time.The wire flushed with saline prior to use.The user was not aware of any flaking on the wire.The reporter is unsure how the coating was activated, how long the coating was activated, or if the coating was reactivated before reuse.The reporter stated they are not aware of any unintended section of the device remaining inside the patients body, if the patient was hospitalized or had prolonged hospitalization, if the patient required any additional procedures, if there were any adverse effects on the patient, or if there were any surgical/medical interventions performed due to this occurrence.

• Brand Name: HIWIRE NITINOL 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: 15550029
• MDR Text Key: 306916373
• Report Number: 1820334-2022-01593
• Device Sequence Number: 1
• Product Code: OCY
• UDI-Device Identifier: 00827002304727
• UDI-Public: (01)00827002304727(17)240824(10)71001971
• 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,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date: 12/28/2022

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
• Device Operator: Health Professional
• Device Model Number: G30472
• Device Catalogue Number: HWA-038150
• Device Lot Number: 71001971
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 09/13/2022
• Initial Date FDA Received: 10/06/2022
• Supplement Dates Manufacturer Received: 11/04/2022; 12/01/2022
• Supplement Dates FDA Received: 11/29/2022; 12/28/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/25/2021
• 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