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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 Entrapment of Device (1212); Material Twisted/Bent (2981); Adverse Event Without Identified Device or Use Problem (2993)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 12/04/2023
Event Type  malfunction  
Event Description
It was reported that catheter issue occurred.The target lesion was located in a 100% stenosed, moderately tortuous, severely calcified common femoral artery.An opticross peripheral imaging catheter was advanced for ultrasound examination however, it got stuck in the lesion.Severe twisting of the catheter was also noted.The catheter was then removed from the body and the procedure was completed using another opticross peripheral.There were no patient complications reported.
 
Event Description
It was reported that catheter issue occurred.The target lesion was located in a 100% stenosed, moderately tortuous, severely calcified common femoral artery.An opticross peripheral imaging catheter was advanced for ultrasound examination however, it got stuck in the lesion.Severe twisting of the catheter was also noted.The catheter was then removed from the body and the procedure was completed using another opticross peripheral.There were no patient complications reported.
 
Manufacturer Narrative
The device was returned for analysis.Visual inspection revealed a kink on the sheath assembly and the catheter was twisted at 20 cm and 21.7 cm from the lap joint section.Microscope inspection also revealed the catheter was twisted at 20 cm and 21.7 cm from the lap joint section and the guidewire exit port was damaged, but the tip was in good condition.It is possible that the reported anatomical factors of the lesion could generate a constriction over the catheter increasing the friction between the lesion, guidewire and the exit port assembly, resulting in the damage observed, and consequently, entrap the device.Therefore, the most probable cause to the observed issue is adverse event related to patient condition.Regarding the observed kink in the sheath, this can occur in the procedure during the advancement maneuvers, since in this process, the friction between the catheter and the lesion creates a force that opposes the movement of the catheter.If the pushing force from the user and this opposing force caused by the friction, are not parallel to each other, the sheath could bend and consequently collapse into a kink.Since the dhr review confirmed that the device met all manufacturing specifications, it is most probable that the forces which lead to the kink were found during the procedure.Due to the reported anatomical factors, it is possible that the friction between the catheter body and the lesion caused the opposing force that kinked the sheath, thus, adverse event related to patient condition is the assigned cause for the encountered kink in the sheath.All compiled information on this investigation determines that the most probable cause is: cause not established.
 
Manufacturer Narrative
The device was returned for analysis.Visual inspection revealed a kink on the sheath assembly and the catheter was twisted at 20 cm and 21.7 cm from the lap joint section.Microscope inspection also revealed the catheter was twisted at 20 cm and 21.7 cm from the lap joint section and the guidewire exit port was damaged, but the tip was in good condition.It is possible that the reported anatomical factors of the lesion could generate a constriction over the catheter increasing the friction between the lesion, guidewire and the exit port assembly, resulting in the damage observed, and consequently, entrap the device.Therefore, the most probable cause to the observed issue is adverse event related to patient condition.Regarding the observed kink in the sheath, this can occur in the procedure during the advancement maneuvers, since in this process, the friction between the catheter and the lesion creates a force that opposes the movement of the catheter.If the pushing force from the user and this opposing force caused by the friction, are not parallel to each other, the sheath could bend and consequently collapse into a kink.Since the dhr review confirmed that the device met all manufacturing specifications, it is most probable that the forces which lead to the kink were found during the procedure.Due to the reported anatomical factors, it is possible that the friction between the catheter body and the lesion caused the opposing force that kinked the sheath, thus, adverse event related to patient condition is the assigned cause for the encountered kink in the sheath.All compiled information on this investigation determines that the most probable cause is: cause not established.
 
Event Description
It was reported that catheter issue occurred.The target lesion was located in a 100% stenosed, moderately tortuous, severely calcified common femoral artery.An opticross peripheral imaging catheter was advanced for ultrasound examination however, it got stuck in the lesion.Severe twisting of the catheter was also noted.The catheter was then removed from the body and the procedure was completed using another opticross peripheral.There were no patient complications reported.
 
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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 Key18401056
MDR Text Key331677530
Report Number2124215-2023-73523
Device Sequence Number1
Product Code ITX
Combination Product (y/n)N
Reporter Country CodeJA
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,Followup,Followup
Report Date 03/19/2024
2 Devices were Involved in the Event: 1   2  
1 Patient was Involved in the Event
Date FDA Received12/27/2023
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 Number0031914250
Was Device Available for Evaluation? Device Returned to Manufacturer
Is the Reporter a Health Professional? Yes
Date Manufacturer Received03/14/2024
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured06/28/2023
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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