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

Model Number H74939272S1

Device Problem Difficult to Insert (1316)

Patient Problems Death (1802); Low Blood Pressure/ Hypotension (1914); Cardiogenic Shock (2262); Aortic Dissection (2491)

Event Date 06/30/2015

Event Type  Death  

Event Description

Three separate safari guidewires were used in this one case so separate mdr's (2126666-2015-00042, 2126666-2015-00043 & 2126666-2015-00044) are being filed for each safari wire involved.Per cnf: patient approved for lotus implantation.Tortuous peripheral anatomy but with big enough diameters on both sides to accommodate the large sheath.Left side access decided.Lotus large sheath was successfully inserted and valve was prepared and given for insertion.After a while of catheter advancement (still on iliac), the first operator experienced resistance and as we saw on the screen it was on the position of a curve of the iliac vessel.Decision was taken to stop, remove the catheter and change the safari wire and try to straighted the sheath by partially removing and readvancing it with its dilator.Valve was kept underwater and still sheathed without any obvious damage.They tried again with same results.They again took the catheter out.For the third time they changed the sheath and safari wire (3rd one).For this time, the valve was unsheathed, carefully inspected, flushed and re-sheathed again successfully and without any damage.They managed to advance the catheter through the sheath and the anatomy and started to implant the valve.During unsheathing the valve there was a drop on patient`s pressure observed.They tried to implant the valve quickly but there were 2 early clicks occurred before locking so the team decided to resheath and remove the valve and deal with the pressure drop.They were suspecting a bleeding due to some dissection somewhere in the anatomy.There was no annulus rupture according to transthoracic assessment.The contrast injection in abdominal aorta showed a small dissection in the low part of abdominal aorta close to bifurcation.Decision was taken to surgically treat the patient.The patient made it through surgery and currently recovering on a stable status.Additional info received on july 16, 2015.The patient unfortunately passed away on friday july 3.As per physician sayings the reason for patient`s death was a cardiogenic shock in severe af.This might came as result from the elongated occlusion which might have caused renal failure and eventually multiple organs failure.

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.Review of the dfu notes the reported event as potential adverse event associated with the tavi/tavr use of the device.If the guidewires were only introduced into or withdrawn from the ventricle through a catheter as required by the directions for use the safari guidewires would not come into contact with the abdominal aorta.A combination of patient and procedural factors appear to have caused or contributed to this incident.Other text : device not returned for evaluation.

• 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: 4926385
• MDR Text Key: 6029275
• Report Number: 2126666-2015-00044
• 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
• Reporter Occupation: Health Professional
• Type of Report: Initial
• Report Date: 07/20/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Physician
• Device Expiration Date: 04/28/2018
• Device Model Number: H74939272S1
• Device Catalogue Number: 39272S
• Device Lot Number: 10528166
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 07/07/2015
• Initial Date FDA Received: 07/20/2015
• 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 Outcome(s): Death