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

Model Number	M006630200B1
Medical Device Problem Codes	Device Damaged by Another Device (2915); Material Split, Cut or Torn (4008)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	08/18/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
As received, the specimen consisted of one-1 each hydro gw std s 150-018; returned coiled, loose, accompanied by the skived polymer jacket material and the labelled portion of the packaging pouch, and double bagged within "zip-lock" style poly pouches.The specimen presented cut/skive damage to the polymer jacket material 8.00 to 16.75cm from the distal tip, exposing 8.70cm of the metallic core wire.The specimen also presented bend damage over the distal 13.5cm, consistent with tensile loading.The returned specimen included 8.65cm of polymer jacket material skived from the specimen wire.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 above, the specimen presented cut/skive damage to the polymer jacket material 8.00 to 16.75cm from the distal tip, exposing 8.70cm of the metallic core wire.The specimen also presented bend damage over the distal 13.5cm, consistent with tensile loading.The specimen also included 8.65cm of polymer jacket material skived from the specimen wire.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 damage presented by the specimen appeared consistent with withdrawal through a metal cannula or needle.As indicated in the device instructions for use, 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 the 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." multiple attempts have been made to obtain additional event and patient information from the end-user.At the time of this report, no additional information has been received.Note that the recorded age in section a2 is an estimate.The actual age of the patient is unknown.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.If any further information is received, a follow up medwatch report will be submitted.
Event or Problem Description
Per medwatch report # (b)(4): fragment of the glidewire used to place the r subclavian cvl sheared off the device and was retained in the central venous system following the procedure.

• Brand Name: ZIPWIRE HYDROPHILIC GUIDEWIRE
• Common Device Name: UROLOGICAL CATHETER AND ACCESSORIES
• Manufacturer (Section D): LAKE REGION MEDICAL; 340 lake hazeltine drive; chaska MN 55318
• MDR Report Key: 12525995
• Report Number: 2126666-2021-00039
• Device Sequence Number: 20127140
• Product Code: EYA
• UDI-Device Identifier: 08714729802433
• UDI-Public: 08714729802433
• Combination Product (Y/N): N
• Initial Reporter State: CT
• Initial Reporter Country: US
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: other
• Initial Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date (Section B): 09/24/2021

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 Expiration Date: 11/30/2023
• Device Model Number: M006630200B1
• Device Catalogue Number: 630-200B
• Device Lot Number: 6090560
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/22/2021
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/09/2021
• Initial Report FDA Received Date: 09/24/2021
• 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: Other
• Patient Age: 50 YR