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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 Problems Difficult to Flush (1251); Detachment of Device or Device Component (2907); Material Deformation (2976); Adverse Event Without Identified Device or Use Problem (2993)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 10/17/2023
Event Type  malfunction  
Manufacturer Narrative
E1: initial reporter address 1 - (b)(6).
 
Event Description
It was reported that a catheter issue occurred.The target lesion was located in the left coronary artery.The opticross hd imaging catheter was selected for use.When pretreated to flush the catheter outside the patient, it was found out that there was no liquid coming out from tip of the device.It was further reported that the device has a detached imaging window and a kinked drive cable.The procedure was completed with another of same device.There were no patient complications reported.
 
Event Description
It was reported that a catheter issue occurred.The target lesion was located in the left coronary artery.The opticross hd imaging catheter was selected for use.When pretreated to flush the catheter outside the patient, it was found out that there was no liquid coming out from tip of the device.It was further reported that the device has a detached imaging window and a kinked drive cable.The procedure was completed with another of same device.There were no patient complications reported.
 
Manufacturer Narrative
E1: (b)(6).The device was not returned for analysis.A media review of a picture provided by the client showed a difficult to flush catheter, imaging window was detached and kinked, and the drive cable was kinked in the distal section.H3 other text : media.
 
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Brand Name
OPTICROSS HD
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 shields
4100 hamline ave n
arden hills, MN 55112
6512422111
MDR Report Key18539559
MDR Text Key333336638
Report Number2124215-2023-76019
Device Sequence Number1
Product Code OBJ
Combination Product (y/n)N
Reporter Country CodeCH
PMA/PMN Number
K173284
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Foreign,Health Professional,Company Representative,Distributor
Reporter Occupation Physician
Type of Report Initial
Report Date 02/13/2024
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received01/18/2024
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model Number8668
Device Catalogue Number8668
Device Lot Number0031884299
Was Device Available for Evaluation? No
Date Returned to Manufacturer11/22/2023
Is the Reporter a Health Professional? Yes
Date Manufacturer Received01/22/2024
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured06/26/2023
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
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