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

Model Number H74939406XS1

Device Problems Entrapment of Device (1212); Flaked (1246); Material Deformation (2976)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 02/04/2019

Event Type  malfunction  

Manufacturer Narrative

No product was provided for analysis; however the end user did provide lot traceability.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 at lake region medical and was determined to be acceptable.The complaint is non-verifiable as the product was not returned for evaluation.At this time it is not possible to assign a definitive root cause for the event as reported.If additional information is received or the product is returned for analysis a follow-up medwatch report will be submitted.

Event Description

As reported by the distributor: per clinical, it was reported that: "after deployment and release of the valve, nose cone was resheathed into the delivery system.As delivery system was being withdrawn, the safari wire felt stiff but could still be advanced.As the delivery system was withdrawn into the sheath, the wire locked completed (right at the point of withdrawal from sheath).- the wire and the delivery system were removed together out of the sheath.- there were no adverse effects from this complaint." the procedure was reportedly completed.

Manufacturer Narrative

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 at lake region medical and was determined to be acceptable.The product was returned for analysis.As received, the specimen consisted of one-1 safari2 275cm x sml crv; returned coiled, loose and double-bagged within "zip-lock" style poly biohazard pouches.The delivery system associated with the complaint was not returned with the specimen wire.The specimen presented an overall length of 276.50cm, curve dimensions of 3.20cm x 3.80cm, and a finished diameter of.03450" to.03460".A gage bushing certified to be.0355" passed over the length of the specimen to either aspect of the coil damage with no more effort than the mass of the bushing sliding down the wire shaft unaided, except by gravity.The specimen device was not returned lodged within the delivery system.The specimen presented multi-directional bend/twist damage to the small diameter curve and bend damage located 23.0 to 34.5cm from the distal aspect of the formed curve and stretched coil wraps located 79.7 to 80.1cm from the distal aspect of the formed curve.The specimen also presented several offset/overlapping coil wraps in the large diameter curve and scattered over the length of the wire creating localized oversized diameters to.03960" and varying amounts of scraped ptfe coating, with coating removal, scattered over the length of the device.All joints appeared to be correct and intact.Except where noted, the specimen device appeared visually and dimensionally correct.The specimen device was not returned lodged within the delivery system, preventing confirmation of the event as reported.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 confirm the complaint or assign a definitive root cause for the event as reported.As noted in the complaint narrative, there was no reported issue with the specimen wire until "the delivery system was withdrawn into the sheath".Based on the information provided and the evidence presented, it appears that clinical and/or procedural factors have contributed to 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: 8373986
• MDR Text Key: 137294799
• Report Number: 2126666-2019-00008
• 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: 03/08/2019

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: 05/31/2021
• Device Model Number: H74939406XS1
• Device Catalogue Number: 39406XS1
• Device Lot Number: 11003901
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/06/2019
• Initial Date Manufacturer Received: 02/04/2019
• Initial Date FDA Received: 02/27/2019
• Supplement Dates Manufacturer Received: 02/04/2019
• Supplement Dates FDA Received: 03/08/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 85 YR