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

Catalog Number HWA-035150

Device Problem Peeled/Delaminated (1454)

Patient Problem No Code Available (3191)

Event Date 10/15/2020

Event Type  Injury  

Manufacturer Narrative

Blank fields on this form indicate the information is unknown or unavailable.Device information lot # : 5763839 or 5710853 customer unable to confirm lot #.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.This report is based on unconfirmed information submitted by others.Neither the submission of this report nor any statement made in it is intended to be an admission that any cook device is defective or malfunctioned; that a death or serious injury occurred; or that any cook device caused or contributed to; or is likely to cause or contribute to a death or serious injury if a malfunction occurred.

Event Description

It was reported, during a percutaneous nephrolithotomy (pcnl), while trying to remove a hiwire nitinol hydrophilic wire guide, the coating of the wire got "caught" and sheared about 7 inches off in the patient's kidney.A flexible nephroscopy was performed and a basket was used to remove the coating from the patient.Two hiwire nitinol hydrophilic wire guides were opened during this case.One from lot number 5763839 and one from lot number 5710853.The customer is not sure which lot number, the wire guide with the alleged malfunction described above, came from.The procedure was able to be completed.No unintended section of the device remained inside the patient¿s body.No additional patient consequences were reported.

Manufacturer Narrative

Blank fields on this form indicate the information is unchanged, unknown or unavailable.H6: ec method code desc - 5: communication/interviews (4111).Event summary: as reported, an unknown patient required the use of a hiwire nitinol hydrophilic wire guide during a percutaneous nephrolithotomy (pcnl) procedure.This procedure is used when a kidney stone is unable to be passed through the urine.The operator reported during the procedure while attempting to remove the wire guide, the coating of the wire got ¿caught¿ and sheared approximately seven inches off into the patient¿s kidney.The operator performed a flexible nephroscopy with a basket and removed the coating from the patient¿s kidney without further incident.The original procedure was completed successfully.No additional adverse effects were reported.Investigation - evaluation.A document-based investigation was performed including a review of complaint history, manufacturing instructions, instructions for use (ifu), specifications, and quality control data.The complaint device was not returned; therefore, no physical examinations could be performed.A review of the device history record found no nonconformances associated with either of the suspected lots.A review of complaint history records shows no other complaints associated with either of the suspected lots.The device is packaged with instructions for use which caution, "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.When exchanging or withdrawing an instrument over the wire guide, secure and maintain the wire guide in place under fluoroscopy in order to avoid unexpected wire guide displacement." a clinical assessment of this event was completed and concluded that based on the information provided, it is probable that inadvertent user manipulation of wire guide along with use of other instrumentation could have contributed to this failure.Clinical assessment cannot, however, eliminate any possible causes for this event such as product handling, medical procedure, device failure, or manufacturing related causes.The complaint device was not returned for evaluation as it was discarded following the operation.Reviews of the device history records of cook and of the device supplier did not find any indication the complaint device was manufactured out of specification.While a specific cause for the separated coating could not be determined, the investigation cannot rule out damage during use of the wire guide by additional instruments or mishandling during the procedure.Per the quality engineering risk assessment, no further action is warranted.Cook medical will continue to monitor this device via the complaints database for similar complaints.This report is required by the fda under 21 cfr part 803.This report is based on unconfirmed information submitted by others.Neither the submission of this report nor any statement made in it is intended to be an admission that any cook device is defective or malfunctioned; that a death or serious injury occurred; or that any cook device caused or contributed to; or is likely to cause or contribute to a death or serious injury if a malfunction occurred.

Event Description

No new patient or event information since the last report was submitted.

• 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
• MDR Report Key: 10746541
• MDR Text Key: 213410800
• Report Number: 1820334-2020-01948
• Device Sequence Number: 1
• Product Code: OCY
• Combination Product (y/n): N
• PMA/PMN Number: K082536
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup
• Report Date: 12/07/2020

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 Catalogue Number: HWA-035150
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 10/15/2020
• Initial Date FDA Received: 10/28/2020
• Supplement Dates Manufacturer Received: 12/01/2020
• Supplement Dates FDA Received: 12/07/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention