MAUDE Adverse Event Report: LAKE REGION MEDICAL PREFORM GUIDEWIRE - SAFARI2; WIRE GUIDE

Model Number H74939406S1

Device Problems Flaked (1246); Material Deformation (2976)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 01/28/2019

Event Type  malfunction  

Manufacturer Narrative

Reportable based on analysis of the returned specimen exhibiting frayed ptfe coating.A review of the device history records of the specimen device did not present any indication of manufacturing defect or anomaly that could have impacted on the event as reported.The history records indicate this product was final inspection tested and was determined to be acceptable.As received, the specimen consisted of one-1 safari2 275cm sml crv; returned coiled, loose and double-bagged within "zip-lock" style poly biohazard pouches.The specimen presented kink/bend damage located 73.25 to 73.50cm from the distal aspect of the formed curve with large radius bends over the distal 20cm and proximal 10 cm of the wire shaft.The specimen also presented offset/overlapping coil wraps located 72.65 to 72.80cm from the distal aspect of the formed curve creating a localized oversized diameter to.04265".The region of offset/overlapping coil wraps presented damaged and removed ptfe coating.The report of damage is confirmed.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.As indicated in the follow-up communications, the "kink occurred during procedure, but which point and where it occurred is unknown".At this time, it is not possible to assign a definitive root cause for the event as reported.As indicated in the warnings section of the device instructions for use (dfu), "exercise care in handling of the guidewire during a procedure to reduce the possibility of accidental breakage, bending, kinking or coil separation".The operational instructions of the dfu also notes, " safari2 guidewires should be handled carefully and inspected before use and when possible during the procedure to observe for any defect or damage that may occur.Do not use a wire that has damaged coating, tip, camber (change in plane), bend or kink on the wire.Damage will hinder the performance of the safari2 guidewire.Prior to use and when possible during the procedure, inspect the wire carefully for coil separation, bends, or kinks which may have occurred.Do not use a wire which has a damaged tip.Damage will hinder the performance of the guidewire".Based on the information provided and the evidence presented by the returned guidewire, it appears that clinical and/or procedural factors contributed to the event as reported.

Event Description

As reported: it was reported that: the wire got kinked.Kink occurred during procedure, but which point and where it occurred is unknown.Procedure outcome: completed with another of same device.

• Brand Name: PREFORM GUIDEWIRE - SAFARI2
• Type of Device: WIRE GUIDE
• 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: jackie ohnsorg ; 340 lake hazeltine drive; chaska, MN 55318 ; 9526418516
• MDR Report Key: 8374528
• MDR Text Key: 139343065
• Report Number: 2126666-2019-00011
• Device Sequence Number: 1
• Product Code: DQX
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K151244
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 02/27/2019

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
• Device Operator: Health Professional
• Device Expiration Date: 09/30/2021
• Device Model Number: H74939406S1
• Device Catalogue Number: 39406S1
• Device Lot Number: 11060589
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/19/2019
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 02/19/2019
• Initial Date FDA Received: 02/27/2019
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/10/2018
• 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: 85 YR