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

Model Number H74939272S

Device Problem Material Distortion (2977)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 09/08/2015

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.A combination of patient and procedural factors appear to have caused or contributed to this incident.The product is expected to be returned for failure analysis.If additional information is received or the product is returned for analysis a follow-up medwatch report will be submitted.Waiting product return.

Event Description

After successful release of a 27mm lotus valve and during the initial withdrawal of the device there was a movement observed of the lotus bioprosthesis towards the ascending aorta on the left coronary side which resulted on a higher than intended implantation but without compromising the hemodynamics of the patient.The implanting hcps found it very difficult to remove the safari wire from the patient`s left ventricle.Tried with various catheters apart from the pigtail.It was believed that the wire was somehow caught in the mitral valve.They finally managed to withdraw the safari wire.On its inspection outside of the patient there seemed to be a kind of disconnection of the wire`s stiff to soft part on its transition spot.Patient is stable and recovering.

• Brand Name: PREFORM GUIDEWIRE - SAFARI
• 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: 5128129
• MDR Text Key: 27489224
• Report Number: 2126666-2015-00065
• Device Sequence Number: 1
• Product Code: DQX
• Combination Product (y/n): N
• Reporter Country Code: PL
• PMA/PMN Number: K130798
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,foreign
• Reporter Occupation: Health Professional
• Report Date: 10/05/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/05/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Physician
• Device Expiration Date: 04/28/2018
• Device Model Number: H74939272S
• Device Catalogue Number: 39272S
• Device Lot Number: 10528166
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/14/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/30/2015
• 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