MAUDE Adverse Event Report: LAKE REGION MEDICAL ZIPWIRE HYDROPHILIC GUIDEWIRE; WIRE, GUIDE, CATHETER

Model Number	M00146151B1
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	12/28/2021
Type of Reportable Event	Serious Injury
Additional 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.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 final inspection tested at (b)(6) medical and was determined to be acceptable.As indicated in the device instructions for use, warnings: do not manipulate or withdraw the zipwire hydrophilic guide wire through a metal entry needle or metal dilator.Manipulation and/or withdrawal through a metal entry needle or metal dilator may result in destruction and or separation of the outer polyurethane coating, requiring retrieval.A plastic entry needle is recommended when using this wire for initial placement.To prevent possible tissue damage, care should be taken when manipulating a device over a zipwire hydrophilic guide wire during the device's placement or withdrawal.If resistance is felt during device placement, discontinue the procedure and determine the cause of resistance before proceeding.If the cause of resistance cannot be determined, remove the zipwire hydrophilic guide wire and device as a unit to prevent possible damage and/or complications.If any resistance is felt or if the tip's behavior and/or location seems improper, stop manipulating the zipwire hydrophilic guide wire and/or catheter and determine the cause under fluoroscopy.Failure to exercise proper caution may result in bending, kinking, separation of the guide wire's tip, damage to the catheter or damage to the vessel.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.Based on the information provided, it appears that clinical and/or procedural factors impacted on the event as reported.If there is any further relevant information provided, a follow up report will be submitted.
Event or Problem Description
Event description: please provide a brief summary of the event that includes any additional details that you have not already provided: dialysis catheter exchange was procedure, they advanced the wire through old catheter, then removed old catheter.Placed new catheter over that wire.When catheter was secured in body they went to remove wire and it fractured approximately halfway down the wire shaft.At that point they tried to snare wire out but couldn't.Patient was transferred to outside facility where wire was successfully removed endovascular method.Unknown outside location at this time.What troubleshooting steps took place? what troubleshooting steps, if any, resolved the issue?: attempted to remove wire per normal procedure.What is the next course of action?: n/a.Patient present at time of event?: yes.Patient complications: additional intervention required.In the physician's opinion, did the device or procedure cause or contribute to the patient complication?: yes.Please describe the way in which the device or procedure caused or contributed to the patient complication?: wire couldn't be removed and patient transferred to outside facility to handle.Medical or surgical interventions: outside facility removed wire.Patient admitted to hospital beyond the standard of care: unknown.Patient outcome: fully recovered.Reason for unsuccessful procedure: wire was left in patient and patient was transferred to outside facility.Was the patient sedated when the procedure was cancelled?: yes.What is the anatomical location of the lesion being treated? dialysis catheter placement so wire is venous through svc into right atrium.When during the procedure did the device fracture (unpacking, preparation, introduction, use, removal, packaging for shipment, etc)? during removal.
Additional 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.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 final inspection tested at (b)(6) medical and was determined to be acceptable.As indicated in the device instructions for use, warnings: do not manipulate or withdraw the zipwire hydrophilic guide wire through a metal entry needle or metal dilator.Manipulation and/or withdrawal through a metal entry needle or metal dilator may result in destruction and or separation of the outer polyurethane coating, requiring retrieval.A plastic entry needle is recommended when using this wire for initial placement.To prevent possible tissue damage, care should be taken when manipulating a device over a zipwire hydrophilic guide wire during the device's placement or withdrawal.If resistance is felt during device placement, discontinue the procedure and determine the cause of resistance before proceeding.If the cause of resistance cannot be determined, remove the zipwire hydrophilic guide wire and device as a unit to prevent possible damage and/or complications.If any resistance is felt or if the tip's behavior and/or location seems improper, stop manipulating the zipwire hydrophilic guide wire and/or catheter and determine the cause under fluoroscopy.Failure to exercise proper caution may result in bending, kinking, separation of the guide wire's tip, damage to the catheter or damage to the vessel.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.Based on the information provided, it appears that clinical and/or procedural factors impacted on the event as reported.If there is any further relevant information provided, a follow up report will be submitted.
Event or Problem Description
Event description: please provide a brief summary of the event that includes any additional details that you have not already provided: dialysis catheter exchange was procedure, they advanced the wire through old catheter, then removed old catheter.Placed new catheter over that wire.When catheter was secured in body they went to remove wire and it fractured approximately halfway down the wire shaft.At that point they tried to snare wire out but couldn't.Patient was transferred to outside facility where wire was successfully removed endovascular method.Unknown outside location at this time.What troubleshooting steps took place? what troubleshooting steps, if any, resolved the issue?: attempted to remove wire per normal procedure.What is the next course of action?: n/a.Patient present at time of event?: yes.Patient complications: additional intervention required.In the physician's opinion, did the device or procedure cause or contribute to the patient complication?: yes.Please describe the way in which the device or procedure caused or contributed to the patient complication?: wire couldn't be removed and patient transferred to outside facility to handle.Medical or surgical interventions: outside facility removed wire.Patient admitted to hospital beyond the standard of care: unknown.Patient outcome: fully recovered.Reason for unsuccessful procedure: wire was left in patient and patient was transferred to outside facility.Was the patient sedated when the procedure was cancelled?: yes.What is the anatomical location of the lesion being treated? dialysis catheter placement so wire is venous through svc into right atrium.When during the procedure did the device fracture (unpacking, preparation, introduction, use, removal, packaging for shipment, etc)? during removal.
Event or Problem Description
Event description: please provide a brief summary of the event that includes any additional details that you have not already provided: dialysis catheter exchange was procedure - they advance wire through old catheter, then removed old catheter.Placed new catheter over that wire.When catheter was secured in body they went to remove wire and it fractured approximately halfway down the wire shaft.At that point they tried to snare wire out but couldn't.Patient was transferred to outside facility where wire was successfully removed endovascular method.Unknown outside location at this time.What troubleshooting steps took place? what troubleshooting steps, if any, resolved the issue?: attempted to remove wire per normal procedure what is the next course of action?: patient present at time of event?: yes.Patient complications: additional intervention required.In the physician's opinion, did the device or procedure cause or contribute to the patient complication?: yes.Please describe the way in which the device or procedure caused or contributed to the patient complication?: wire couldn't be removed and patient transferred to outside facility to handle.Medical or surgical interventions: outside facility removed wire.Patient admitted to hospital beyond the standard of care: unknown.Patient outcome: fully recovered.Reason for unsuccessful procedure: wire was left in patient and patient was transferred to outside facility.Was the patient sedated when the procedure was cancelled?: yes.What is the anatomical location of the lesion being treated? dialysis catheter placement so wire is venous through svc into right atrium when during the procedure did the device fracture (unpacking, preparation, introduction, use, removal, packaging for shipment, etc)? during removal.
Additional Manufacturer Narrative
Section d4: expiration date on initial report 9680001-2022-00001 was incorrect.Correct expiration date: august 5, 2024.

• Brand Name: ZIPWIRE HYDROPHILIC GUIDEWIRE
• Common Device Name: WIRE, GUIDE, CATHETER
• Manufacturer (Section D): LAKE REGION MEDICAL; 340 lake hazeltine drive; chaska MN 55318
• Manufacturer (Section G): VENUSA DE MEXICO S. DE R.L. DE C.V.; calle hertz 1525; parque industrial a j bermudez; ciudad juarez, chihuahua 32470 ; MX 32470
• Manufacturer Contact: victoria foss ; 340 lake hazeltine drive; chaska, MN 55318 ; 9526418506
• MDR Report Key: 13283257
• Report Number: 9680001-2022-00001
• Device Sequence Number: 4872660
• Product Code: DQX
• UDI-Device Identifier: 08714729754695
• UDI-Public: 08714729754695
• Combination Product (Y/N): N
• Initial Reporter State: OH
• Initial Reporter Country: US
• PMA/510(K) Number: K000011
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Distributor
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 01/21/2022

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
• Operator of Device: Health Professional
• Device Expiration Date: 08/05/2024
• Device Model Number: M00146151B1
• Device Catalogue Number: 46-151B
• Device Lot Number: JRZ6551507
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/04/2022
• Supplement Date Received by Manufacturer: 01/04/2022
• Initial Report FDA Received Date: 01/18/2022
• Supplement Report FDA Received Date: 01/21/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 08/05/2021
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown