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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BOSTON SCIENTIFIC - MAPLE GROVE KINETIX?; WIRE, GUIDE, CATHETER
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BOSTON SCIENTIFIC - MAPLE GROVE KINETIX?; WIRE, GUIDE, CATHETER Back to Search Results
Model Number H74939122010
Device Problems Detachment Of Device Component (1104); Difficult to Advance (2920)
Patient Problems Bradycardia (1751); Chest Pain (1776); Thrombosis (2100); Device Embedded In Tissue or Plaque (3165)
Event Date 01/28/2015
Event Type  Injury  
Event Description
It was reported that thrombosis, chest pain, bradycardia and guide wire tip detachment occurred.The target lesion was located in the right coronary artery (rca).There was a previously implanted stent in the proximal rca.A 185cm kinetix¿ guide wire was advanced to the lesion however the wire went down a side branch of the rca.The device was pulled back to re-wire distally, however, the device became caught on or behind a stent strut of the previously implanted stent.It was then noted that the tip of the guide wire broke off and was left in the side branch of the rca.The remaining portion of the guide wire was able to be removed.Approximately 5-7 minutes later, the rca was filled with thrombus and the patient was noted to have bradycardia and chest pain.A non bsc guide wire was advanced to the native rca.Then a 3.0x32mm veriflex stent was implanted over the side branch to open up the vessel and to jail the detached tip and the procedure was completed.No further patient complications were reported and the patient's status was fine.
 
Manufacturer Narrative
(b)(4).
 
Manufacturer Narrative
Device evaluated by mfr: returned product consisted of a kinetix guidewire and an extra kinetix guidewire.The extra guidewire was not damaged.The guidewire was completely separated 108.5cm from the proximal end.Magnified inspection of the fracture surface appear to be consistent with separation due to ductile bending overload.The distal end was not returned for analysis.There was no damage or irregularities to the bonds.The manufacturing batch record review confirmed that the device met all material, assembly and performance specifications.The most probable root cause is operational context as device performance was limited due to anatomical procedural factors.(b)(4).
 
Event Description
It was reported that thrombosis, chest pain, bradycardia and guide wire tip detachment occurred.The target lesion was located in the right coronary artery (rca).There was a previously implanted stent in the proximal rca.A 185cm kinetix¿ guide wire was advanced to the lesion however the wire went down a side branch of the rca.The device was pulled back to re-wire distally, however, the device became caught on or behind a stent strut of the previously implanted stent.It was then noted that the tip of the guide wire broke off and was left in the side branch of the rca.The remaining portion of the guide wire was able to be removed.Approximately 5-7 minutes later, the rca was filled with thrombus and the patient was noted to have bradycardia and chest pain.A non bsc guide wire was advanced to the native rca.Then a 3.0x32mm veriflex stent was implanted over the side branch to open up the vessel and to jail the detached tip and the procedure was completed.No further patient complications were reported and the patient's status was fine.
 
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Brand Name
KINETIX?
Type of Device
WIRE, GUIDE, CATHETER
Manufacturer (Section D)
BOSTON SCIENTIFIC - MAPLE GROVE
one scimed place
maple grove MN 55311
Manufacturer Contact
linda leimer
one scimed place
maple grove, MN 55311
7634941700
MDR Report Key4536644
MDR Text Key21837073
Report Number2134265-2015-00771
Device Sequence Number1
Product Code DQX
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K081021
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Health Professional,Company Representative
Reporter Occupation Physician
Type of Report Initial,Followup
Report Date 01/29/2015
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? Yes
Device Operator Health Professional
Device Expiration Date09/04/2016
Device Model NumberH74939122010
Device Catalogue Number39122-01
Device Lot Number17256935
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer02/18/2015
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 04/15/2015
Initial Date FDA Received02/23/2015
Supplement Dates Manufacturer ReceivedNot provided
Supplement Dates FDA Received05/06/2015
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured09/05/2014
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
Patient Outcome(s) Required Intervention;
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