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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION OPTICROSS HD; CATHETER, ULTRASOUND, INTRAVASCULAR
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BOSTON SCIENTIFIC CORPORATION OPTICROSS HD; CATHETER, ULTRASOUND, INTRAVASCULAR Back to Search Results
Model Number 8668
Device Problem Device Contamination with Chemical or Other Material (2944)
Patient Problem No Patient Involvement (2645)
Event Date 12/11/2019
Event Type  malfunction  
Event Description
It was reported that during unpacking of an opticross hd imaging catheter, an object like a hair was found and another of the same device was used instead.
 
Manufacturer Narrative
Device evaluated by mfr.: the device was received inside of the original sealed pouch and a fiber that looks like a hair was found inside the pouch.No other visual damages were found.For the microscopic inspection, a fiber that looks like a hair was found inside the pouch.
 
Event Description
It was reported that during unpacking of an opticross hd imaging catheter, an object like a hair was found and another of the same device was used instead.
 
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Brand Name
OPTICROSS HD
Type of Device
CATHETER, ULTRASOUND, INTRAVASCULAR
Manufacturer (Section D)
BOSTON SCIENTIFIC CORPORATION
two scimed place
maple grove MN 55311
MDR Report Key9512633
MDR Text Key176778916
Report Number2134265-2019-16102
Device Sequence Number1
Product Code OBJ
Combination Product (y/n)N
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,distri
Type of Report Initial,Followup
Report Date 03/03/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/23/2019
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Expiration Date09/05/2020
Device Model Number8668
Device Catalogue Number8668
Device Lot Number0024383000
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer01/14/2020
Date Manufacturer Received02/07/2020
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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