MAUDE Adverse Event Report: COOK INC JEFFREY WIRE GUIDE EXCHANGE SET; KGZ ACCESSORIES, CATHETER

Model Number G12016

Device Problem Material Separation (1562)

Patient Problem Foreign Body In Patient (2687)

Event Date 06/22/2021

Event Type  Injury  

Manufacturer Narrative

Occupation: lead radiology tech.Pma / 510(k) #: exempt.A follow-up report will be submitted should additional relevant information become available.

Event Description

It was reported that the radiopaque ring of a jeffrey wire guide exchange set became dislodged and trapped in the patient's renal calyx.The device was placed in the patient's kidney via direct stick with sheath access.As a result of the radiopaque ring being dislodged, an unspecified intervention was performed using additional wires and balloons as well as a different sheath to retrieve the radiopaque ring, but was unsuccessful.The initial procedure was ultimately completed by obtaining a second access.The radiopaque ring remains in the patient's kidney.The patient is currently stable, and it is unknown at this time if any further interventions will be performed as a result.No other adverse effects have been reported.

Manufacturer Narrative

Investigation ¿ evaluation.(b)(6) medical center in the united states informed cook of an incident involving a jwge-104-rh-nt (jeffrey wire guide exchange set) from lot 13620948.It was reported that the radiopaque ring of the device was dislodged and trapped in the renal calix.The user was able to complete the procedure by obtaining a second access.The radiopaque ring remains in the kidney.There was an intervention to attempt to obtain it with additional wires, balloons and a different sheath but it was unsuccessful.The patient is stable, and they do not know if there will be any additional interventions.A review of the complaint history, device history record, instructions for use (ifu), and quality control procedures of the device, as well as a visual inspection of the returned product, were conducted during the investigation.One device was returned in a used condition.The radiopaque ring was confirmed missing.Additionally, a document based investigation evaluation was performed.The device of the device master record (dmr) confirmed that there are controls in place to address the reported failure mode.A review of the device history record (dhr) was also conducted as a part of the investigation to check for failure related nonconformances and additional complaints.The dhr for the complaint lot records no relevant non-conformances.A database search for complaints on the reported lot found no additional complaints reported from the field.Therefore, it was concluded that no nonconforming product from this lot exists in house or in the field.The device is not shipped with instruction for use (ifu), so no review of product labeling was conducted.The information provided upon review of device master record, device history record, and device failure analysis suggests the device was manufactured to specification.There is no evidence to suggest items in the lot or similar devices in the field or in house are nonconforming.It was concluded that component failure unrelated to manufacturing or design deficiencies contributed to this incident.The appropriate internal personnel have been notified.Per the risk assessment, no further action is required.Cook will continue to monitor for similar complaints.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: JEFFREY WIRE GUIDE EXCHANGE SET
• Type of Device: KGZ ACCESSORIES, CATHETER
• 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: 12076031
• MDR Text Key: 258656158
• Report Number: 1820334-2021-01618
• Device Sequence Number: 1
• Product Code: KGZ
• UDI-Device Identifier: 00827002120167
• UDI-Public: (01)00827002120167(17)231210(10)13620948
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 05/19/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 12/10/2023
• Device Model Number: G12016
• Device Catalogue Number: JWGE-104-RH-NT
• Device Lot Number: 13620948
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 06/22/2021
• Initial Date FDA Received: 06/28/2021
• Supplement Dates Manufacturer Received: 04/25/2022
• Supplement Dates FDA Received: 05/20/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/10/2020
• 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 Outcome(s): Required Intervention; Other
• Patient Age: 77 YR
• Patient Sex: Male
• Patient Weight: 85 KG