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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION SYSTEM ACCESSORY; SYSTEM, IMAGING, PULSED ECHO, ULTRASONIC
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BOSTON SCIENTIFIC CORPORATION SYSTEM ACCESSORY; SYSTEM, IMAGING, PULSED ECHO, ULTRASONIC Back to Search Results
Model Number 8815
Device Problem Retraction Problem (1536)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 08/01/2018
Event Type  malfunction  
Event Description
It was reported that automatic pullback failure occurred.The 10% stenosed target lesion was located in the mildly tortuous and mildly calcified mid left anterior descending artery.An ilab ultrasound imaging system was used in conjunction with an imaging catheter and a pullback sled to view the target lesion.However, during procedure, it was reported that whenever the physician put the sled on the motor drive unit (mdu) in the sterile bag, it would not pull the catheter back.They utilized a new sled and everything worked fine.No patient complications were reported.
 
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Brand Name
SYSTEM ACCESSORY
Type of Device
SYSTEM, IMAGING, PULSED ECHO, ULTRASONIC
Manufacturer (Section D)
BOSTON SCIENTIFIC CORPORATION
two scimed place
maple grove MN 55311
Manufacturer (Section G)
EP TECHNOLOGIES, INC.
150 baytech drive
san jose CA 95134
Manufacturer Contact
sonali arangil
two scimed place
maple grove, MN 55311
6515827403
MDR Report Key7859832
MDR Text Key119669431
Report Number2134265-2018-60862
Device Sequence Number1
Product Code DQK
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K151613
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,health
Reporter Occupation Physician
Type of Report Initial
Report Date 09/10/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received09/10/2018
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model Number8815
Device Catalogue Number8815
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Date Manufacturer Received08/27/2018
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Is the Device Single Use? Yes
Type of Device Usage Initial
Patient Sequence Number1
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