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

Model Number H74939406XS1

Device Problem Difficult to Insert (1316)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Type  malfunction  

Manufacturer Narrative

The device has been received for analysis; however, at the time of this report the evaluation was still in-process.The manufacturing batch record review confirmed that the device met all material, assembly and inspection specifications.A follow up medwatch report will be filed upon completion of the evaluation.

Event Description

During a tavi procedure (no lotus procedure), the physician wanted to use the safari 2 xs guidewire.He referred that while he was inserting the safari 2 xs into the catheter (cordis 6fr amplatz al) using the j-straightener, he felt high resistance and he could insert only a few centimeters of the guidewire into the catheter.Then he noticed that the coil around the safari 2 was removed.He changed the broken safari 2 xs with a new safari 2 xs.The procedure was completed with another of the same device.Problem was noticed during introduction outside of the patient.

Manufacturer Narrative

The manufacturing batch record review confirmed that the device met all material, assembly and inspection specifications.As received, the specimen consists of one each clinically used, damaged safari2 275cm x sml crv; returned coiled, loose and double bagged within "zip-lock" style poly biohazard pouches.The specimen presents a fracture of the core wire 0.758cm from the distal tip; the fracture presents indications of bending overload low cycle fatigue fracture.The specimen presents bends over the distal 7.58mm and over the 5.80mm immediately proximal of the core wire fracture.The specimen also presents stretched coil damage located 2.00 to 3.20mm from the distal tip and from 4.22mm from the distal tip to approximately 6.10cm from the distal apex of the formed curve; exposing 0.35cm of the core wire distal of the fracture and 9.40cm of the core wire proximal of the fracture.No other damage or inconsistencies are noted to the specimen at this time.Both joints appear to be correct and intact by visual examination and by non-destructive testing.Except where noted, the specimen device appears visually and dimensionally correct.Based on the evidence presented by the sample and the information provided by the supporting documentation, 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
• 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: 5532069
• MDR Text Key: 41428059
• Report Number: 2126666-2016-00031
• 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: Physician
• Type of Report: Initial,Followup
• Report Date: 04/14/2016

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: 09/30/2018
• Device Model Number: H74939406XS1
• Device Catalogue Number: 39406XS1
• Device Lot Number: 10610274
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/28/2016
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/11/2016
• Initial Date FDA Received: 03/29/2016
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 04/14/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/28/2015
• 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