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

Catalog Number HWS-035150

Device Problem Material Separation (1562)

Patient Problems Foreign Body In Patient (2687); Insufficient Information (4580)

Event Date 07/13/2023

Event Type  Injury  

Event Description

As reported, while inserting the hiwire nitinol hydrophilic wire guide during an unknown procedure, a small part of the sheath detached from the body of the device and was in the unspecified body cavity.It is unknown if or how the device fragment was retrieved.Additional information regarding event details, patient anatomy and outcome has been requested but is not available at this time.

Manufacturer Narrative

Blank fields on this form indicate the information is unknown or unavailable.D9: device available for eval: unknown.H3: device evaluated by mfg = other (code unspecified, describe in h10) (81) = product to be returned: unknown.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 03aug2023 and 07aug2023: as reported, the covering of a 'hiwire nitinol hydrophilic wire guide' separated from the device during a procedure.The user was performing a percutaneous nephrolithotomy (pcnl) on a female patient with renal calculi and 'complex urinary anatomy'.The user inserted the guidewire using an 18g chiba needle.Due to the 'complex urinary anatomy' of the patient, the user had to remove the guidewire from the inner channel of the needle.During removal, the needle 'stripped' the guidewire and part of the covering separated and remained in the patient; this resulted in the use of other medical devices and prolongation of surgery.The fragment remained in the patient upon cessation of the case.It is planned for the patient to return to the user facility in late august for a follow-up ct scan to check if the fragment is still retained or if it was naturally flushed from the body.Pending results from the scan, the user will explore other solutions for fragment retrieval.Additional information regarding event details, device use, and patient outcome has been requested but is not available at this time.

Manufacturer Narrative

B5: additional information received 03aug2023 and 07aug2023.B7: pre-existing conditions.D9: device available for eval.H3: device evaluated by mfg.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.

Manufacturer Narrative

Blank fields on this form indicate the information is unchanged, unknown, or unavailable.Investigation ¿ evaluation.As reported, while inserting a 'hiwire nitinol hydrophilic wire guide' during a percutaneous nephrolithotomy (pcnl) procedure, the polymer jacket separated from the device in 50 year old female patient.During the procedure, the user inserted the guidewire through an 18g needle.Due to the 'complex urinary anatomy' of the patient, the user had to remove the guidewire from the inner channel of the needle.During removal, the needle 'stripped' the guidewire and part of the polymer jacket separated and remained in the patient.The fragment remained in the patient upon cessation of the case.The patient was expected to pass the guidewire piece voluntarily from the body, and was scheduled to be reevaluated.Though requested, no additional information has been received from the facility.No other adverse effects have been reported.Reviews of the complaint history, device history record (dhr), and quality control procedures, as well as a visual inspection of the returned device, were conducted during the investigation.The complaint device was returned without packaging or label for evaluation.The black coating was stripped from the distal tip of the wire.The investigation found that the affected component is supplied to cook from another manufacturer.Cook requested that the supplier investigate this occurrence.Evaluation of the returned device presented skived/cut damage to the polymer jacket material with exposure of the metallic core wire.The damage presented by the specimen appeared consistent with manipulation of the guidewire against resistance.The supplier investigation concluded that the product met specification at the time of shipment.Additionally, 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.Cook's review of the device history record, complaint history, quality control documents, and device failure analysis indicates that the device was manufactured within specifications and does not suggest items in the lot or similar devices in the field or in house are nonconforming.Cook also reviewed product labeling.The wire guide was supplied with ifu t_hbwg2_rev1 which includes the following: - 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." - instructions for use: "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." based on the information provided, inspection of the returned device, and the results of the investigation, a definitive root cause was unable to be established.Handling and/or procedural factors could not be ruled out.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.

Event 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
• 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: 17436855
• MDR Text Key: 320198193
• Report Number: 1820334-2023-00994
• Device Sequence Number: 1
• Product Code: OCY
• UDI-Device Identifier: 00827002304741
• UDI-Public: (01)00827002304741(17)251113(10)71003004
• 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,Health Professional,User Facility,Company Representative
• Reporter Occupation: Pharmacist
• Type of Report: Initial,Followup,Followup
• Report Date: 11/21/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/01/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: HWS-035150
• Device Lot Number: 71003004
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/07/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/14/2022
• 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
• Treatment: CITOCUT CHIBA NEEDLE 18GX250MM
• Patient Outcome(s): Other
• Patient Age: 50 YR
• Patient Sex: Female