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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: LAKE REGION MEDICAL PREFORM GUIDEWIRE - SAFARI; WIRE GUIDE
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LAKE REGION MEDICAL PREFORM GUIDEWIRE - SAFARI; WIRE GUIDE Back to Search Results
Device Problems Stretched (1601); Uncoiled (1659); Material Torqued (2980); Torn Material (3024)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 12/13/2017
Event Type  malfunction  
Manufacturer Narrative
The manufacturing batch lot was not provided; therefore, a review of the device history records for the guidewire involved in this incident could not be completed.The device was not received for analysis; therefore, no physical analysis of the product could be performed.The product is reportedly being returned for analysis but wasn't received by the time this report was submitted.Based on the information received to date an exact cause for the incident could not definitely be determined.If the product is returned for analysis or additional information is received a follow-up medwatch report will be submitted.
 
Event Description
As reported; safari wire coil came of the core.Per additional information received: it looked like it was separated like inner and outer coil.This was during sliding a balloon over the wire for predilatation.We took a new safari 2 wire.We did successfully implant an accurate valve with good outcome."patient is doing fine and is back home".This was product that was purchased last year and they unfortunately disposed the package so there is no information about the product but in my eyes it looked like the old safari wire.
 
Manufacturer Narrative
The manufacturing batch lot was not provided; therefore, a review of the device history records for the guidewire involved in this incident could not be completed.The safari guidewire was received for analysis january 17, 2018.As received, the specimen consists of one-1 unknown safari device; returned coiled, loose and double-bagged within "zip-lock" style poly biohazard pouches.The specimen presents a ductile, tensile, overload fracture of the core wire 0.041cm from the distal tip weld mass with subsequent coil stretching.The exposed core wire also presents bend damage with torsional loading 1.36 to 2.22cm from the proximal aspect of the core wire fracture in addition to several bends of varying severity and frequency scattered over the shaft of the device.In addition to the stretched coil wraps over the distal 83cm, the specimen also presents offset/overlapping coil wraps with frayed coating and coating removal scattered over the proximal 72cm.No other damage or inconsistencies are noted to the specimen at this time.The proximal joint appears to be correct and intact by visual examination and by non-destructive testing.Except where noted, the specimen device appears visually and dimensionally correct for a safari 300cm small curve device.As noted in the warnings section of the device instructions for use (dfu), "do not torque this guidewire" and "never advance the guidewire against resistance without first determining the reason for the resistance under fluoroscopy.Excessive force against resistance may result in damage to the catheter or vessel/organ." at this time it is not possible to assign a definitive root cause for the event as reported.Based on the evidence presented by the returned sample and the information provided by the supporting documentation, clinical and/or procedural factors appear to have impacted on the event as reported.
 
Event Description
As reported; safari wire coil came of the core.Per additional information received: it looked like it was separated like inner and outer coil.This was during sliding a balloon over the wire for predilatation.We took a new safari 2 wire.We did successfully implant an accurate valve with good outcome."patient is doing fine and is back home".This was product that was purchased last year and they unfortunately disposed the package so there is no information about the product but in my eyes it looked like the old safari wire.
 
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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 Key7186335
MDR Text Key97859767
Report Number2126666-2018-00004
Device Sequence Number1
Product Code DQX
Combination Product (y/n)N
Reporter Country CodeSW
PMA/PMN Number
K130798
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type distributor
Reporter Occupation Health Professional
Type of Report Initial,Followup
Report Date 02/25/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received01/12/2018
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Physician
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer01/17/2018
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? No
Date Manufacturer Received12/18/2017
Was Device Evaluated by Manufacturer? Yes
Is the Device Single Use? Yes
Type of Device Usage Initial
Patient Sequence Number1
Patient Age85 YR
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