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

Model Number M006630222B1

Device Problem Device Damaged by Another Device (2915)

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

Event Date 01/10/2022

Event Type  malfunction  

Manufacturer Narrative

The device was not recieived 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.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: do not manipulate, advance and/or withdraw the zipwire hydrophilic guidewire through a metal cannula or needle.Manipulation, advancement, and/or withdrawal through a metal device may result in destruction and/or separation of the outer polymer jacket requiring retrieval.If a needle is used for initial placement, a plastic entry needle is recommended when using the zipwire hydrophilic guidewire.Extreme caution should be observed when used with a one-wall puncture needle.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.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

It was reported that the ptfe peeled off.The device is expected to be returned before feb 10th.Is clinical? no.What was the patient condition following procedure? stable.Where did the problem occur? inside the patient.Event resolved? yes.Additional information received january 25, 2022: 1.Was there any patient injury reported? no.2.Was it the first time the device was used? if not, how many times had it been? yes.3.Was there visible damage to the device and/or its packaging prior to use? except reported, no.4.How was the procedure(s) completed? (i.E.Was the same device exchanged for another of the same, different device, etc.)? completed with another of the same device.5.Did this event occur during insertion, advancement or withdrawal? during procedure.6.Did any part of the guidewire detach inside the patient? no.

Manufacturer Narrative

Device evaluation: as received, the specimen consisted of one-1 each hydro gw stf std s 150-035; returned reloaded into dispenser assembly in labelled packaging pouch and single bagged in a "zip-lock" style poly biohazard pouch.An extra "zip-lock" style poly biohazard pouch bag was enclosed in the product packaging pouch.The specimen presented an overall length of 150.7cm and a finished diameter of.03140" to.03245".A gage bushing certified to be.0350" passed over the length of the specimen with no more effort than the mass of the bushing sliding down the wire shaft unaided, except by gravity, to either aspect of the polymer jacket damage.The specimen presented skive/cut damage to the polymer jacket material in a proximal to distal orientation 38.2 cm to 68.4cm from the distal tip and a large radius bend over the distal 9.2 cm.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.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 evidence presented, it appeared that clinical and/or procedural factors have contributed to the event as reported.As noted in the device instructions for use (dfu) warnings: do not manipulate, advance and/or withdraw the zipwire hydrophilic guidewire through a metal cannula or needle.Manipulation, advancement, and/or withdrawal through a metal device may result in destruction and/or separation of the outer polymer jacket requiring retrieval.If a needle is used for initial placement, a plastic entry needle is recommended when using the zipwire hydrophilic guidewire.Extreme caution should be observed when used with a one-wall puncture needle.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.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

It was reported that the ptfe peeled off.The device is expected to be returned before feb 10th.Is clinical? no.What was the patient condition following procedure? stable.Where did the problem occur? inside the patient.Event resolved? yes.Additional information received january 25, 2022: was there any patient injury reported? no.Was it the first time the device was used? if not, how many times had it been? yes.Was there visible damage to the device and/or its packaging prior to use? except reported, no.How was the procedure(s) completed? (i.E.Was the same device exchanged for another of the same, different device, etc.)? completed with another of the same device.Did this event occur during insertion, advancement or withdrawal? during procedure.Did any part of the guidewire detach inside the patient? no.

• 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: 13415430
• MDR Text Key: 295785887
• Report Number: 2126666-2022-00004
• Device Sequence Number: 1
• Product Code: EYA
• UDI-Device Identifier: 08714729755326
• UDI-Public: 08714729755326
• Combination Product (y/n): N
• Reporter Country Code: CH
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Distributor
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date: 08/11/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/01/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 06/30/2023
• Device Model Number: M006630222B1
• Device Catalogue Number: 630-222B
• Device Lot Number: 5877525
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Manufacturer Received: 01/19/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/04/2020
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Age: 55 YR
• Patient Sex: Male
• Patient Weight: 65 KG