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 05/11/2018

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 does 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 returned specimen consisted of one safari2 275cm sml crv; returned coiled, loose and double-bagged within "zip-lock" style poly biohazard pouches.The specimen presented bend damage in the large diameter curve and at 170.0 to 182.0cm from the distal aspect of the formed curve, and an offset overlapping coil condition located 186.25 to 186.40 cm from the distal aspect of the formed curve creating a localized oversized diameter of.04180".The ptfe coating in the vicinity of the offset/overlapping coil wraps was frayed and presented coating removal.At this time it is not possible to assign a definitive root cause for the event as reported.Based on the evidence presented by the sample and the information provided by the supporting documentation, clinical and/or procedural factors appear to have impacted on the event as reported.

Event Description

As reported: during the introducing of loaded accurate neo, delivery system stuck inside of isleeve right after the crossing of hemostatic valve.It was not possible to advance the system through the sheath.New sheath, new valve and new delivery system was used to finish procedure.Case ended with a good result.Additional information received stated the following: the wire was kinked outside the sheath on the proximal end.With such kink is it impossible to advance the new system.Additionally we were not sure about presence of a kink inside the introducer.From our longtime experience with accurate neo we do know that even a small hardly visible kink or knot on the wire could cause stacking.That's why we decided to collect the wire as well.

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 does 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 returned specimen consisted of one safari2 275cm sml crv; returned coiled, loose and double-bagged within "zip-lock" style poly biohazard pouches.The specimen presented several kinks/bends located 9.0 to 45.5cm, 70.0 to 71.8cm, 212.0 to 214.5cm and 244.5 to 265.5cm from the distal apex of the preformed curve.The specimen also presented scraped/frayed ptfe coating with coating removal located 212.0 to 214.55cm from the distal apex of the preformed curve.The specimen presented deposits of dried blood-like material on and between the coil wraps scattered over the length of the device.No other damage or inconsistencies were noted.Both joints appeared to be correct and intact by visual examination and by non-destructive testing.Except where noted, the specimen device appeared visually and dimensionally correct.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 evidence presented by the sample and the information provided by the supporting documentation, clinical and/or procedural factors appear to have impacted on the event as reported.

• Brand Name: PREFORM GUIDEWIRE - SAFARI2
• Type of Device: WIRE GUIDE
• Manufacturer (Section D): LAKE REGION MEDICAL; 340 lake hazeltine drive; chaska MN 55318
• MDR Report Key: 7683898
• MDR Text Key: 113886542
• Report Number: 2126666-2018-00051
• Device Sequence Number: 1
• Product Code: DQX
• Combination Product (y/n): N
• PMA/PMN Number: K151244
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor
• Type of Report: Initial,Followup
• Report Date: 08/15/2018

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: 02/28/2021
• Device Model Number: H74939406S1
• Device Catalogue Number: 39406S1
• Device Lot Number: 10968034
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/06/2018
• Initial Date Manufacturer Received: 07/06/2018
• Initial Date FDA Received: 07/12/2018
• Supplement Dates Manufacturer Received: 07/06/2018
• Supplement Dates FDA Received: 08/17/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 86 YR