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

Model Number	M00146151B1
Medical Device Problem Code	Device Damaged by Another Device (2915)
Health Effect - Clinical Code	Insufficient Information (4580)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
As received, the specimen consisted of one-1 each hydro gw std an 150-035; returned partially reloaded into the dispenser assembly, within the opened, labeled packaging pouch, accompanied by the skived polymer jacket material within a capped 90cc specimen cup, and double-bagged within "zip-lock" style poly biohazard pouches.The lack of lot traceability prevents performing a device history records review for 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 specimen presented cut/skive damage 11.30 to 38.30cm from the distal tip exposing the metallic core wire 11.45 to 37.85cm from the distal tip.The cut skive damage resulted in the separation of 26.50cm of polymer jacket from the body of the specimen.Our investigation was unable to confirm that the product did not meet specification prior to shipment.The investigation concluded that the product met specification at the time of shipment.The cut/skive damage appeared consistent with manipulation of the specimen wire within a metal needle or other metal device.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." at this time, it is not possible to assign a definitive root cause for the event as reported.Based on the information provided to date, it appears that clinical and/or procedural factors impacted on the event as reported.The patient information and event date were not provided at the time of this report.Additionally, the lot number was not provided and therefore the actual place of manufacture could not be determined.If there is any further relevant information provided, a follow up medwatch report will be submitted.
Event or Problem Description
Event description: per email, it was reported that: this piece of guidewire got stuck in a patient during surgery.Additional information from wip report: complaint summary: it was reported that unretrieved device fragment occurred.A 035/150 zipwire (zipwire hydrophilic guide wire) was advanced for treatment.However, during surgery, piece of the guidewire was stuck in the patient.No further information provided.Additional information received at a later date stated: "a piece of guidewire got stuck in a patient during surgery and we have that piece here and it needs to be sent off for investigation.".

• Brand Name: ZIPWIRE HYDROPHILIC GUIDEWIRE
• Common Device Name: WIRE, GUIDE, CATHETER
• Manufacturer (Section D): LAKE REGION MEDICAL; 340 lake hazeltine drive; chaska MN 55318
• MDR Report Key: 11579881
• Report Number: 9680001-2021-00030
• Device Sequence Number: 4182253
• Product Code: DQX
• UDI-Device Identifier: 08714729763895
• UDI-Public: 08714729763895
• Combination Product (Y/N): N
• Initial Reporter State: GA
• 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: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 03/26/2021

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
• Operator of Device: Health Professional
• Device Model Number: M00146151B1
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/16/2021
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/02/2021
• Initial Report FDA Received Date: 03/27/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention