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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BOSTON SCIENTIFIC - FREMONT (SUD) GALAXY INTRAVASCULAR ULTRASOUND SYSTEM; SYSTEM, IMAGING, PULSED ECHO, ULTRASONIC
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BOSTON SCIENTIFIC - FREMONT (SUD) GALAXY INTRAVASCULAR ULTRASOUND SYSTEM; SYSTEM, IMAGING, PULSED ECHO, ULTRASONIC Back to Search Results
Model Number H749A70200
Device Problem Communication or Transmission Problem (2896)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 09/17/2015
Event Type  malfunction  
Manufacturer Narrative
Age at time of event: 18 years or older.Device evaluated by mfr: it is indicated that the device will not be returned for evaluation.A review of the batch history, historical trending, and similar complaint trending review for the product family will be conducted.If there is any further relevant information from that review, a supplemental medwatch will be filed.(b)(4).
 
Event Description
Same case as: 2134265-2015-07025, 2134265-2015-07028 and 2134265-2015-07026.It was reported that automatic pullback failure occurred.The 75% stenosed target lesion was located in the moderately tortuous and moderately calcified vessel.During a percutaneous coronary intervention (pci) with intravascular ultrasound (ivus), an ilab ultrasound imaging system was used in conjunction with an opticross¿ imaging catheter and a sled to view the target lesion.It was noted that the opticross¿ imaging catheter was not recognized.The imaging catheter was then reconnected; however, the issue was not resolved.Therefore, the console was rebooted up and then setting up was performed.However, it was noted that it was unable to perform automatic pullback.The imaging catheter was then exchanged with another opticross¿ imaging catheter but this issue was not resolved.Thus, manual pullback was performed.The procedure was completed with another of the same device.No patient complications were reported and the patient's status is good.
 
Manufacturer Narrative
Device evaluated by manufacturer: the complaint device was returned for evaluation.Evaluation revealed that no damages found on the returned pullback sled.The returned sled was able to properly connect to the motor drive unit (mdu).During functional testing using a test catheter, the sled was able to properly pull back and performed within specifications.No issues or defects were observed during product analysis of the returned accessory.The manufacturing batch record review confirmed that the device met all material, assembly and performance specifications.The root cause is not confirmed as there was no evidence of the alleged issue or any anomalies which could have contributed to the reported difficulty.(b)(4).
 
Event Description
Same case as: 2134265-2015-07025, 2134265-2015-07028 and 2134265-2015-07026.It was reported that automatic pullback failure occurred.The 75% stenosed target lesion was located in the moderately tortuous and moderately calcified vessel.During a percutaneous coronary intervention (pci) with intravascular ultrasound (ivus), an ilab ultrasound imaging system was used in conjunction with an opticross¿ imaging catheter and a sled to view the target lesion.It was noted that the opticross¿ imaging catheter was not recognized.The imaging catheter was then reconnected; however, the issue was not resolved.Therefore, the console was rebooted up and then setting up was performed.However, it was noted that it was unable to perform automatic pullback.The imaging catheter was then exchanged with another opticross¿ imaging catheter but this issue was not resolved.Thus, manual pullback was performed.The procedure was completed with another of the same device.No patient complications were reported and the patient's status is good.
 
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Brand Name
GALAXY INTRAVASCULAR ULTRASOUND SYSTEM
Type of Device
SYSTEM, IMAGING, PULSED ECHO, ULTRASONIC
Manufacturer (Section D)
BOSTON SCIENTIFIC - FREMONT (SUD)
47215 lakeview blvd phone
west dock
fremont CA 94538
Manufacturer (Section G)
BOSTON SCIENTIFIC - FREMONT (SUD)
47215 lakeview blvd phone
west dock
fremont CA 94538
Manufacturer Contact
linda leimer
one scimed place
maple grove, MN 55311
7634941700
MDR Report Key5150893
MDR Text Key28595653
Report Number2134265-2015-07027
Device Sequence Number1
Product Code IYO
Combination Product (y/n)N
PMA/PMN Number
K980851
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,distri
Reporter Occupation Physician
Type of Report Initial,Followup
Report Date 09/17/2015
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received10/14/2015
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Expiration Date06/28/2016
Device Model NumberH749A70200
Device Catalogue NumberA7020
Device Lot NumberS1004362
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer10/13/2015
Is the Reporter a Health Professional? Yes
Date Manufacturer Received12/31/2015
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured06/08/2015
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
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