MAUDE Adverse Event Report: LAKE REGION MEDICAL ZIPWIRE HYDROPHILIC GUIDEWIRE; UROLOGICAL CATHETER AND ACCESSORIES

Model Number M006630205B1

Device Problems Device Damaged by Another Device (2915); Material Split, Cut or Torn (4008)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 10/21/2021

Event Type  Injury  

Manufacturer Narrative

It was reported that the device was disposed; therefore, no physical analysis of the device can be performed.A review of the device history records of the specimen device does 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 history records indicate this product was final inspection tested at lake region medical and was determined to be acceptable.As noted in the device instructions for use (dfu) warnings, manipulate the zipwire hydrophilic guidewire slowly and carefully in the urinary system while confirming the behavior and location of the wire's tip under fluoroscopy.Excessive manipulation of the zipwire hydrophilic guidewire without fluoroscopic confirmation may result in perforation or trauma of the linings or associated tissues, channels or ducts.If any resistance is felt or if the tip's behavior and/or location seem improper, stop manipulating the wire and/or catheter and determine the cause by fluoroscopy.Failure to exercise proper caution may result in bending, kinking, separation of the zipwire hydrophilic guidewire's tip, damage to the catheter, or damage to the urinary system.If necessary, remove the zipwire hydrophilic guidewire and ancillary device or scope as a complete unit to avoid complications.The dfu precautions also indicate, the zipwire hydrophilic guidewire should be advanced through the scope using short, deliberate 2-3cm movements to prevent inadvertent damage to the device or patient.Due to variations in certain catheter tip diameters, abrasion of the hydrophilic coating may occur during manipulation.If any resistance is felt during introduction of the catheter, it is advisable to stop using such catheters.The complaint is non-verifiable as the product was not returned for evaluation.Based on the information provided, it appeared that clinical and/or procedural factors may have impacted on the event as reported.At this time, it is not possible to assign a definitive root cause for the event as reported.If any further information is received, a follow up medwatch report will be submitted.

Event Description

Event description: it was reported that: the doctor was finishing up the case and was pulling out both the safety wire and working wire when it was noticed some of the wire fell off in the patient.The doctor then used a 2 prong grasper to go back and get the remaining wire that was left inside the patient.What was the outcome of the procedure?: procedure completed successfully.Patient complications: no patient complications.What troubleshooting steps took place? none, this was towards the end of the case so the doctor went back in and grabbed the remaining portion of the wire that was left behind.Device used to complete procedure: it was at the end of the case so another wire was not needed.Failure modes related to this device include: detachment of device or device component.Were the issues present upon opening the package?: no.How was the procedure completed (with another of the same device, with a different device, etc.)? this was the end of the procedure so he did not need another wire.If there was a procedure involved, was it for treatment or diagnosis? treatment.If there was a procedure involved, what was the anatomy location? ureter and kidney.Which device was used with the wire when the issue was found? he was using 2 prong graspers.Was the problem found during insertion or retraction of the wire? retraction.Please describe what portion of the guidewire detached/peeled hydrophilic tip, ptfe coating, other? the wire broke in half when the doctor was pulling out the wire.Were metal cannula used during the procedure? there was a cystoscope that was used during the procedure.What devices were used with the wire during the procedure? cystoscope, access sheath, 2 prong grasper.Additional information received november 1, 2021: 1.Was there any patient injury reported? no patient complications.2.Were there any patient complications during the procedure(s) or after as a result of the product issue? no patient complications.3.Was it the first time the device was used? if not, how many times had it been? this was the first time the device was used.4.Was there visible damage to the device and/or its packaging prior to use? no visible damage prior to being used.5.Was the guidewire hydrated or rinsed with saline solution prior to removal from the dispenser? yes the wire was rinsed prior to removing from the dispenser.6.Was there an issue with lubricity of the device? to the best of my knowledge there was no issue with the lubrication of the wire.7.Was the zipwire flushed during the procedure? yes, the zipwire was flushed during the procedure.8.Did the physician encounter any resistance while advancing the zipwire to its intended location? the physician did not encounter any resistance in getting the wire to the intended location.9.Did the physician encounter any resistance while removing the zipwire? the physician did not encounter any resistance while removing the wire.10.Was the zipwire advanced through a metal cannula or needle? there was a cystoscope that was used during the procedure.11.How long had the zipwire been inside the patient before it was removed? the zipwire was immediately removed once the doctor pulled out the zip and noticed that part of it was missing.12.Is the metal core wire exposed? the wire broke in half.13.What was the "safety wire"? the safety wire was a sensor wire.14.Is there an image available? unfortunately, there is no image available.

• Brand Name: ZIPWIRE HYDROPHILIC GUIDEWIRE
• Type of Device: UROLOGICAL CATHETER AND ACCESSORIES
• Manufacturer (Section D): LAKE REGION MEDICAL; 340 lake hazeltine drive; chaska MN 55318
• Manufacturer (Section G): LAKE REGION MEDICAL; 340 lake hazeltine drive; chaska MN 55318
• Manufacturer Contact: victoria foss ; 340 lake hazeltine drive; chaska, MN 55318 ; 9526418506
• MDR Report Key: 12790894
• MDR Text Key: 281660246
• Report Number: 2126666-2021-00048
• Device Sequence Number: 1
• Product Code: EYA
• UDI-Device Identifier: 08714729761761
• UDI-Public: 08714729761761
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Distributor
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 11/10/2021

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?: No
• Device Operator: Health Professional
• Device Expiration Date: 06/30/2024
• Device Model Number: M006630205B1
• Device Catalogue Number: 630-205B
• Device Lot Number: 6401339
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 10/27/2021
• Initial Date FDA Received: 11/10/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/22/2021
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention