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

Model Number H74939406XS

Device Problems Difficult to Insert (1316); Kinked (1339)

Patient Problems Intimal Dissection (1333); Rupture (2208)

Event Date 09/07/2015

Event Type  Injury  

Manufacturer Narrative

The device was not received for analysis; therefore no physical 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 not expected to be returned for failure analysis.If additional information is received a follow-up medwatch report will be submitted.Product was disposed of by end user.

Event Description

During the use of safari 2 extra small (lme - limited market evaluation) a iliac dissection occurred.It occurred during insertion of an evolut r 23mm sheathless, at that level there was an angulate tortuosity and the wire kinked causing the rupture.It was solved by putting a covered stent and using an introducer (18f cook) to complete the procedure.

• 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: 5128825
• MDR Text Key: 27523431
• Report Number: 2126666-2015-00067
• 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,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?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Physician
• Device Expiration Date: 06/30/2018
• Device Model Number: H74939406XS
• Device Catalogue Number: 39406XS
• Device Lot Number: 10558840
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/16/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/29/2015
• 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): Required Intervention
• Patient Age: 85 YR