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

Model Number	M006630205B1
Medical Device Problem Codes	Material Deformation (2976); Material Integrity Problem (2978)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	05/21/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
This medwatch report is being filed based on the results of the image analysis which appears to present polymer jacket removal from the distal tip region, exposing the metallic core wire.The product was not received 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 tactile 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.The supplied image appears to present polymer jacket removal from the distal tip region, exposing the metallic core wire.As indicated in the directions for use (dfu), "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.If any further relevant information is provided, a follow up medwatch report will be submitted.
Event or Problem Description
At the time of wanting to use the guide, the doctor noticed that one of the ends had no coating.So he decided not to use it on the patient and submit the complaint.Additionally it was reported that the procedure was completed using a different device (different model).
Additional Manufacturer Narrative
Device evaluation: as received, the specimen consisted of one-1 each hydro gw std s 150-035; returned coiled, loose and single-bagged within a "zip-lock" style poly pouch.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.The specimen presented a ductile, tensile overload fracture of the polymer jacket material, exposing the distal 0.94cm of the metallic core wire; the polymer jacket material distal of the fracture was not returned with the specimen.The polymer jacket damage appears consistent with attempting to remove the wire from the dispenser assembly without proper hydration.As indicated in the directions for use (dfu), "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." 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.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 handling factors have contributed to the event as reported.If there is any further relevant information provided, a follow up medwatch report will be submitted.

• Brand Name: ZIPWIRE HYDROPHILIC GUIDEWIRE
• Common Device Name: UROLOGICAL CATHETER AND ACCESSORIES
• Manufacturer (Section D): LAKE REGION MEDICAL; 340 lake hazeltine drive; chaska, mn
• MDR Report Key: 10148791
• Report Number: 2126666-2020-00034
• Device Sequence Number: 19374155
• Product Code: EZB
• UDI-Device Identifier: 08714729761716
• UDI-Public: 08714729761716
• Combination Product (Y/N): N
• Initial Reporter Country: MX
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: distributor
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 06/25/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 09/30/2022
• Device Model Number: M006630205B1
• Device Catalogue Number: 630-205B
• Device Lot Number: 11181706
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/24/2020
• Initial Date Received by Manufacturer: 06/01/2020
• Supplement Date Received by Manufacturer: 06/24/2020
• Initial Report FDA Received Date: 06/12/2020
• Supplement Report FDA Received Date: 06/25/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 33 YR