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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION OPTICROSS 18; CATHETER, ULTRASOUND, INTRAVASCULAR
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BOSTON SCIENTIFIC CORPORATION OPTICROSS 18; CATHETER, ULTRASOUND, INTRAVASCULAR Back to Search Results
Model Number 44021
Device Problems Device Displays Incorrect Message (2591); Material Twisted/Bent (2981)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 07/06/2023
Event Type  malfunction  
Event Description
It was reported that catheter twist occurred.Vascular access was obtained using radial access with a retrograde approach.Following a successful de-clot of a non-boston scientific graft, an opticross peripheral imaging catheter was advanced to verify results and complete the procedure.The catheter was placed across the lesion and while imaging was being initiated, the screen gave a motor drive unit (mdu) overload error and the mdu shut down.An attempt was made to reinitiate imaging, but the mdu message returned.The catheter tip was visualized using angiography and it could be seen that the catheter had become wrapped around the wire distal to the sheath.An attempt was made to remove the catheter from the arm however, it would not pass into the sheath.The physician cut both the catheter and wire outside the patient and used force to pull the entanglement through the sheath and out of the patient.No patient complications were reported and the procedure was considered successful.
 
Event Description
It was reported that catheter twist occurred.Vascular access was obtained using radial access with a retrograde approach.Following a successful de-clot of a non-boston scientific graft, an opticross peripheral imaging catheter was advanced to verify results and complete the procedure.The catheter was placed across the lesion and while imaging was being initiated, the screen gave a motor drive unit (mdu) overload error and the mdu shut down.An attempt was made to reinitiate imaging, but the mdu message returned.The catheter tip was visualized using angiography and it could be seen that the catheter had become wrapped around the wire distal to the sheath.An attempt was made to remove the catheter from the arm however, it would not pass into the sheath.The physician cut both the catheter and wire outside the patient and used force to pull the entanglement through the sheath and out of the patient.No patient complications were reported, and the procedure was considered successful.
 
Manufacturer Narrative
The device was returned for analysis.Visual inspection revealed a catheter twist in the lap joint section, a cut in the imaging window, and kinks in the imaging window and sheath.The catheter was properly recognized by the imaging system when plugged into the motor drive unit and no connection issues or errors were detected during its testing.A picture provided by the site was inspected and it showed evidence of a twist in the imaging window.
 
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Brand Name
OPTICROSS 18
Type of Device
CATHETER, ULTRASOUND, INTRAVASCULAR
Manufacturer (Section D)
BOSTON SCIENTIFIC CORPORATION
300 boston scientific way
marlborough MA 01752
Manufacturer (Section G)
BOSTON SCIENTIFIC CORPORATION
2546 calle primera
alajuela
CS  
Manufacturer Contact
rachel shields
4100 hamline ave n
arden hills, MN 55112
6512422111
MDR Report Key17398923
MDR Text Key319795633
Report Number2124215-2023-39653
Device Sequence Number1
Product Code OBJ
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K160514
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 09/21/2023
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received07/26/2023
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model Number44021
Device Catalogue Number44021
Device Lot Number0031557989
Was Device Available for Evaluation? Device Returned to Manufacturer
Is the Reporter a Health Professional? Yes
Date Manufacturer Received09/13/2023
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured05/05/2023
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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