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

Model Number H74939407SO

Device Problems Flaked (1246); Difficult to Remove (1528); Deformation Due to Compressive Stress (2889); Material Distortion (2977)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 10/04/2016

Event Type  malfunction  

Manufacturer Narrative

The device was not received for analysis; therefore no physical or visual analysis of the product can be performed.The manufacturing batch record review confirmed that the device met all material, assembly and inspection specifications prior to shipment.Based on the information provided by the supporting documentation, procedural and/or clinical factors appear to have impacted on the event as reported.The guidewire is expected to be returned for analysis.If additional information is received or the product is returned for analysis a follow-up medwatch report will be submitted.No product returned.

Event Description

This mdr is for the second of the two guidewires mentioned below.A safari small and a lotus valve 27 mm were used.When the lotus valve system was outside the introducer, with the guidewire inserted into, the lotus valve system remained blocked without the possibility to move backward and forward.The guidewire has been cut close to the nosecone.A new safari small and a new lotus valve system 27 mm have been used.The valve implantation was successfully completed.During catheter removal and when the catheter was outside the introducer, the catheter remained blocked.Gently pulling, the catheter was removed completely and successfully.At visual inspection, a damage of the safari small guidewire was noticed.

Manufacturer Narrative

The product was returned for analysis.As received, the specimen consisted of one each safari2 275cm sml crv; returned coiled, loose and double-bagged within "zip-lock" style poly biohazard pouches.The returned specimen was consistent with the second wire noted in the complaint narrative, as such the complaint of damage was confirmed.The returned specimen presented bend damage of varying severity and frequency and offset and overlapping coil wraps scattered over the length of the device.The offset coil damage produced localized oversized diameters to.04895".The specimen also presented scraped and missing ptfe coating over the proximal 40cm and at the offset and overlapping coil wraps.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 indicated this product was final inspection tested at lake region medical and was determined to be acceptable.It was 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.If additional information is received a follow-up medwatch report will be submitted.

• 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: 6072656
• MDR Text Key: 59037991
• Report Number: 2126666-2016-00088
• Device Sequence Number: 1
• Product Code: DQX
• Combination Product (y/n): N
• Reporter Country Code: IT
• PMA/PMN Number: K151244
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor
• Reporter Occupation: Health Professional
• Type of Report: Initial,Followup
• Report Date: 03/30/2017

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: 06/30/2018
• Device Model Number: H74939407SO
• Device Catalogue Number: 39407S
• Device Lot Number: 10696858
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/20/2017
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 10/11/2016
• Initial Date FDA Received: 11/02/2016
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 03/30/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/06/2016
• 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