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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION OPTICROSS; CATHETER, ULTRASOUND, INTRAVASCULAR
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BOSTON SCIENTIFIC CORPORATION OPTICROSS; CATHETER, ULTRASOUND, INTRAVASCULAR Back to Search Results
Model Number 8655
Device Problem Device Contamination with Chemical or Other Material (2944)
Patient Problems No Consequences Or Impact To Patient (2199); No Clinical Signs, Symptoms or Conditions (4582)
Event Date 09/30/2019
Event Type  malfunction  
Event Description
It was reported that foreign matter was found.The opticross ic imaging catheter was selected for use.While the device was outside the patient it was noted that an optical fiber remained trapped in the catheter.The procedure was completed with another of the same device.The patient was doing well and has already been discharged from the hospital.
 
Manufacturer Narrative
The device was returned for analysis.Visual inspection revealed the male telescope tubing was adhered to the sheath assembly and the female telescope tube was detached from the male tube.Visual and microscopic inspection revealed that a detached section of the sheath assembly was adhered to the inner walls of the telescope male tube.The device was deconstructed in order to further observed the adhesion between the male telescope tube and the sheath.
 
Event Description
It was reported that foreign matter was found.The opticross ic imaging catheter was selected for use.While the device was outside the patient it was noted that an optical fiber remained trapped in the catheter.The procedure was completed with another of the same device.The patient was doing well and has already been discharged from the hospital.
 
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Brand Name
OPTICROSS
Type of Device
CATHETER, ULTRASOUND, INTRAVASCULAR
Manufacturer (Section D)
BOSTON SCIENTIFIC CORPORATION
two scimed place
maple grove MN 55311
MDR Report Key10457217
MDR Text Key204523340
Report Number2134265-2020-11799
Device Sequence Number1
Product Code OBJ
Combination Product (y/n)N
PMA/PMN Number
K161125
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Type of Report Initial,Followup
Report Date 04/15/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received08/26/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Expiration Date04/01/2020
Device Model Number8655
Device Catalogue Number8655
Device Lot Number0023580859
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer12/18/2020
Date Manufacturer Received03/25/2021
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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