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U.S. Department of Health and Human Services

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

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LAKE REGION MEDICAL ZIPWIRE HYDROPHILIC GUIDEWIRE UROLOGICAL CATHETER AND ACCESSORIES Back to Search Results
Model Number M006630222B1
Device Problem Material Integrity Problem (2978)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 04/08/2021
Event Type  malfunction  
Manufacturer Narrative
The device was not received for evaluation at the time of this report; 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. The supplied images appear to present an undetermined length of the polymer jacket detached from the distal tip, exposing the underlying metallic core wire. 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 indicated in the directions for use (dfu) precautions, "the surface of the zipwire hydrophilic guidewire is not lubricious unless it is wet. Before taking it out of its holder and inserting it through a catheter, fill the holder and the catheter with sterile physiological saline solution. " as noted in the dfu operational instructions, "to activate hydrophilic coating: before removing the zipwire hydrophilic guidewire from the protective hoop (by its distal end), inject physiological saline solution into the hub end of the holder in order to completely wet the surface of the wire. " at this time, it is not possible to assign a definitive root cause for the event as reported. Based on the information provided and the supplied imagery it appeared that handling factors contributed to the event as reported. If there is any further relevant information received, a follow up medwatch report will be submitted.
 
Event Description
It was reported that on (b)(6) 2021, the patient was admitted to hospital due to ureteral calculus. At 9pm, dj catheter placement was needed under guidance of a hydrophilic guidewire. The physician unpacked the guidewire and found one end of the hydrophilic guidewire had no hydrophilic layer, and the inner metal layer of the guidewire was exposed. The physician stopped using the guidewire. The procedure was completed with another guidewire and the physician reported the issue to hospital.
 
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Brand NameZIPWIRE HYDROPHILIC GUIDEWIRE
Type of DeviceUROLOGICAL 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
sharon seifert
340 lake hazeltine drive
chaska, MN 55318
9526418518
MDR Report Key11716382
MDR Text Key249134291
Report Number2126666-2021-00013
Device Sequence Number1
Product Code EYA
Combination Product (y/n)N
Reporter Country CodeCH
PMA/PMN Number
EXEMPT
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type distributor
Reporter Occupation Other Health Care Professional
Type of Report Initial,Followup
Report Date 06/01/2021
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received04/23/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberM006630222B1
Device Catalogue Number630-222B
Device Lot Number5754181
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer05/27/2021
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received05/27/2021
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured04/20/2020
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

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