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

Model Number G30474

Device Problem Peeled/Delaminated (1454)

Patient Problems No Consequences Or Impact To Patient (2199); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 01/27/2021

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

As reported, during a flexible ureteroscopic surgery, the user discovered the coating of a hiwire nitinol hydrophilic wire guide peeled off while advancing a stent on the wire.The user changed to another brand device and completed the procedure.A section of the device did not remain inside the patient¿s body.The patient did not require any additional procedures due to this occurrence.According to the initial reporter, the patient did not experience any adverse effects due to this occurrence.

Manufacturer Narrative

Blank fields on this form indicate the information is unknown, unavailable, or unchanged.Event summary: as reported, during a flexible ureteroscopic surgery, the user discovered the coating of a hiwire nitinol hydrophilic wire guide peeled off while advancing a stent on the wire.The user changed to another brand device and completed the procedure.A section of the device did not remain inside the patient¿s body.The patient did not require any additional procedures due to this occurrence.According to the initial reporter, the patient did not experience any adverse effects due to this occurrence.Investigation - evaluation: reviews of the complaint history, device history record, instructions for use, manufacturing instructions, and quality control procedures and a visual inspection of the device were conducted during the investigation.The device was returned for investigation and sent to the device supplier for evaluation.The device presented an overall length and finished diameter within specification.After flushing the dispenser assembly with saline, the specimen was removed and subjected to visual and tactile examination.The device coating appeared visually and tactilely consistent when examined at 1x ¿ 18 inches, unaided and wet.The specimen presented a large radius bend over the distal 11.5cm and polymer jacket separation/removal from the proximal 0.50cm by ductile/tensile shear overload, exposing the underlying metallic core wire.Except where noted, the specimen device appeared visually and dimensionally correct.The bend damage over the distal 11.5cm appeared consistent with tensile loading, suggesting manipulation of the wire against resistance such as a positional constraint in the distal region.The polymer jacket damage at the proximal end appeared consistent with the efforts to free the device from a constraint condition.A review of the device history records conducted by the supplier 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 tactilely 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 supplier concluded that the product met specification at the time of shipment.A document-based investigation evaluation was also performed by cook.No related non-conformances were recorded.One additional complaint for this product lot was received from the same user facility alleging a similar failure mode.The device history record review provides objective evidence that the device was manufactured to specification.There is no evidence of nonconforming devices from the complaint lot in house or in the field.There were no identified gaps in the manufacturing instructions and quality control procedures.Current controls for manufacturing are in place to assure functionality and device integrity prior to shipping.The device is included with instructions for use which caution, ¿manipulation of wire guide requires appropriate imaging control.Use caution not to force or over manipulate the wire guide when gaining access.When using wire guide through a metal cannula/needle, use caution as damage may occur to outer coating.¿ based on the available information, cook has concluded that the most probable cause of this incident could not be determined.Cook will continue monitoring of similar complaints and have notified the appropriate personnel of this event.Per the quality engineering 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
• MDR Report Key: 11260869
• MDR Text Key: 249060640
• Report Number: 1820334-2021-00221
• Device Sequence Number: 1
• Product Code: OCY
• UDI-Device Identifier: 00827002304741
• UDI-Public: (01)00827002304741(17)230122(10)11209197
• Combination Product (y/n): N
• PMA/PMN Number: K082536
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,foreign,other,use
• Type of Report: Initial,Followup
• Report Date: 05/03/2021

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 Expiration Date: 01/22/2023
• Device Model Number: G30474
• Device Catalogue Number: HWS-035150
• Device Lot Number: 11209197
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/11/2021
• Initial Date Manufacturer Received: 01/28/2021
• Initial Date FDA Received: 02/01/2021
• Supplement Dates Manufacturer Received: 04/15/2021
• Supplement Dates FDA Received: 05/03/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 40 YR