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

Model Number G30474

Device Problem Material Separation (1562)

Patient Problem No Code Available (3191)

Event Date 05/05/2020

Event Type  Injury  

Manufacturer Narrative

(b)(6).(b)(4).This report includes information known at this time.A follow up report will be submitted should additional relevant information become available.

Event Description

It is reported during an unspecified procedure using a hiwire nitinol hydrophilic wire guide, the wire broke in half and stuck inside the patient.The patient needed another unspecified procedure afterwards to remove the device fragment.No adverse effects to the patient have been reported as a result of this occurrence.The patient is reported be "fine".Additional details regarding the patient and event have been requested.At this time, no additional information has been provided.

Manufacturer Narrative

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

Additional information was received: the procedure being performed was a percutaneous nephrostomy lithotomy (pcnl) under local anesthetic.The physician was moving the wire guide forward and backwards slowly to place it in the fitting part of the kidney and the wire guide split lengthways.The wire guide was cut in two, approximately 18 cm from the distal tip and the piece that was cut got stuck in the kidney.The procedure was stopped and a nephrostomy tube was placed.11 days later a second pcnl was performed to remove the piece of the broken wire guide and the remaining stone fragments.The patient's condition after the removal of the wire guide and stone fragments was reported as "ok.".

Event Description

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

Manufacturer Narrative

Blank fields on this form indicate the information is unknown, unchanged, or unavailable.H6: ec method code desc - 5: communication/interviews.Event description: it is reported during a percutaneous nephrolithotomy (pcnl) under local anesthesia using a hiwire nitinol hydrophilic wire guide (and a storz nephroscope-working channel size unknown), the wire broke in half and stuck inside the patient.The physician was moving the wire guide forward and backwards slowly to place it in the fitting part of the kidney and the wire guide split lengthways.The wire guide was cut in two, approximately 18 cm from the distal tip and the piece that was cut got stuck in the kidney.The procedure was stopped, and a nephrostomy tube was placed.11 days later, a second pcnl was performed to remove the piece of the broken wire guide and the remaining stone fragments.The patient's condition after the removal of the wire guide and stone fragments was reported as "ok." there were no additional consequences to the patient as a result of this occurrence.Investigation ¿ evaluation a visual inspection and dimensional verification of the returned device was conducted.A document-based investigation was also performed including a review of complaint history, device history record, the instructions for use, specifications, and quality control data.Visual examination confirmed one wire guide was received in used condition and 42 unopen/ sealed packages.The used device was separated into two segments; a section of the wire jacket measuring 17cm in length received inside a plastic tube.Wire guide jacket was damaged 1.5cm on the flexible end of the wire guide.The metal wire was exposed and visible.The supplier of this device was notified of this occurrence and performed an evaluation of the returned complaint device and five devices from the same lot.A review of the device history records of the specimen device did not present any indication of manufacturing defect or anomaly that could have impacted on the event as reported.During manufacturing the production operators are instructed to 100% visually and tactually inspect for any obvious defect, which includes a tactile examination of the entire length of each wire.In addition, during packaging of this product the operators are instructed to 100% visually inspect for any obvious defect prior to shipment.The history records indicate this product was final inspection tested at the supplier and was determined to be acceptable.As noted above, the specimen presented skive/cut damage 1.455 to 18.8cm, 71.9 to 72.2cm, 73.6 to 83.2cm, 129.2 to 129.5cm,130.4 to 130.7cm and 141.5 to 141.8cm from the distal tip exposing the metallic core wire in each region.The recovered detached polymer jacket segments measured 14.75cm, 2.70cm and 0.15cm; all presented indications of being cut with a sharp-edged device.The metallic core wire was complete and intact.The skive/cut damage over the distal 83.2cm with a proximal to distal orientation, appeared consistent with manipulation of the specimen within a metal cannula/needle.The skive/cut damage over the proximal 31.5cm, with a distal to proximal and rotational orientation appeared consistent with the aggressive application of a torque device to manipulate the specimen wire against resistance.The damage to the clinically used specimen did not present any indication of a manufacturing related issue; therefore, it was determined unnecessary to analyze the unopened specimen devices.A review of the device history record (dhr) found no non-conformances related to the reported failure mode.Because there are no related non-conformances, adequate inspection activities have been established, there is objective evidence that the dhr was fully executed, and no other related complaints from the lot have been received from the field, it was concluded that there is no evidence that nonconforming product exists in house or in field.A review of complaint history records shows no other complaints associated with the complaint device lot.The device is packaged with instructions for use which caution, "manipulation of the wire guide requires appropriate imaging control.Use caution not to force or over manipulate the wire guides when gaining access," and, "when using wire guide through a metal cannula/needle, use caution as damage may occur to outer coating." based on the available information and a supplier evaluation of the device and manufacturing records, cook has concluded that, while a specific cause for this event could not be determined, it is likely that procedural factors contributed to the separation of the device.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.

• 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: 10123645
• MDR Text Key: 194149586
• Report Number: 1820334-2020-01076
• Device Sequence Number: 1
• Product Code: OCY
• UDI-Device Identifier: 00827002304741
• UDI-Public: (01)00827002304741(17)230122(10)11209193
• Combination Product (y/n): N
• PMA/PMN Number: K082536
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,other,user facility
• Type of Report: Initial,Followup,Followup
• Report Date: 11/17/2020

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 Expiration Date: 01/22/2023
• Device Model Number: G30474
• Device Catalogue Number: HWS-035150
• Device Lot Number: 11209193
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/22/2020
• Initial Date Manufacturer Received: 06/02/2020
• Initial Date FDA Received: 06/05/2020
• Supplement Dates Manufacturer Received: 06/05/2020; 11/11/2020
• Supplement Dates FDA Received: 06/25/2020; 11/17/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: STORZ NEPHROSCOPE
• Patient Outcome(s): Other