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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BOSTON SCIENTIFIC - COSTA RICA (COYOL) OPTICROSS¿; CATHETER, ULTRASOUND, INTRAVASCULAR
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BOSTON SCIENTIFIC - COSTA RICA (COYOL) OPTICROSS¿; CATHETER, ULTRASOUND, INTRAVASCULAR Back to Search Results
Model Number H749518080
Device Problem Torn Material (3024)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 01/19/2017
Event Type  malfunction  
Manufacturer Narrative
Age at time of event: 18 years or older.(b)(4).
 
Event Description
It was reported that a tear in the guidewire exit port occurred.The 100% stenosed target lesion was located in a severely tortuous and mildly calcified middle right coronary artery.An opticross¿ imaging catheter was selected for use.After pre-intravascular ultrasound (ivus), the physician tried to cross the opticross¿ imaging catheter to the lesion to perform ivus; however, it was noticed that the transducer moved in a strange direction during removal.Furthermore, it was noted that the guidewire exit port was torn when the opticross¿ was visually checked.The procedure was completed with a non-bsc device.No patient complications were reported.
 
Manufacturer Narrative
Device evaluated by mfr: the device was returned for analysis.Device analysis revealed a damaged on the guidewire exit port assembly.A test guidewire (0.014") was inserted and no indication of resistance in tracking the guidewire into the catheter was noted.It was observed that the catheter flushed normally when the imaging core was fully retracted and fully advanced.Impedance testing shows a good unit wave form.During image characterization testing, a good square image appeared in the ilab system.No other issues or defects were observed during product analysis of the returned device.The manufacturing batch record review confirmed that the device met all material, assembly and performance specifications.The most probable root cause is operational context as device performance was limited due to anatomical procedural factors.(b)(4).
 
Event Description
It was reported that a tear in the guidewire exit port occurred.The 100% stenosed target lesion was located in a severely tortuous and mildly calcified middle right coronary artery.An opticross¿ imaging catheter was selected for use.After pre-intravascular ultrasound (ivus), the physician tried to cross the opticross¿ imaging catheter to the lesion to perform ivus; however, it was noticed that the transducer moved in a strange direction during removal.Furthermore, it was noted that the guidewire exit port was torn when the opticross¿ was visually checked.The procedure was completed with a non-bsc device.No patient complications were reported.
 
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Brand Name
OPTICROSS¿
Type of Device
CATHETER, ULTRASOUND, INTRAVASCULAR
Manufacturer (Section D)
BOSTON SCIENTIFIC - COSTA RICA (COYOL)
2546 first street
propark free zone
alajuela
CS 
Manufacturer (Section G)
BOSTON SCIENTIFIC - COSTA RICA (COYOL)
2546 first street
propark free zone
alajuela
CS  
Manufacturer Contact
sonali arangil
one scimed place
maple grove, MN 55311
7634941700
MDR Report Key6298182
MDR Text Key66446628
Report Number2134265-2017-00756
Device Sequence Number1
Product Code OBJ
Combination Product (y/n)N
PMA/PMN Number
K123621
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,distri
Reporter Occupation Physician
Type of Report Initial,Followup
Report Date 01/19/2017
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received02/02/2017
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Expiration Date09/28/2017
Device Model NumberH749518080
Device Catalogue Number51808
Device Lot Number0019752286
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer01/24/2017
Is the Reporter a Health Professional? Yes
Date Manufacturer Received02/07/2017
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured09/29/2016
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage N
Patient Sequence Number1
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