MAUDE Adverse Event Report: BOSTON SCIENTIFIC - COSTA RICA (COYOL) OPTICROSS¿ 18; CATHETER, ULTRASOUND, INTRAVASCULAR

Model Number H7493932800180

Device Problems Detachment Of Device Component (1104); Device Damaged by Another Device (2915)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 06/05/2017

Event Type  malfunction  

Manufacturer Narrative

Age at time of event: 18 years or older.(b)(4).

Event Description

Same case as mdr id# 2134265-2017-06271 it was reported that tip detachment occurred.The target lesion was located in the iliac vein.After a 5f sheath was inserted and a v-18 control wire crossed the lesion, an opticross 18 imaging catheter was advanced.However, during the procedure, the catheter sheared off or detached at the guide wire lumen.The device remained intact.The device was removed and another opticross 18 imaging catheter was advanced but the same thing happened.The procedure was completed with the third imaging catheter.No patient complications were reported and the patient's status was good.

Manufacturer Narrative

The complaint device was received for analysis.Unit returned in a generic plastic bag, overall visual revision did not identify failures or evidence that could be lost due to decontamination process.A damage was observed on the guidewire exit port assembly.A kink was observed in the imaging window assembly in the distal end.No other visual damages were encountered upon visual inspection and the device does not have detached sections.The telescope assembly was able to properly pull back, advance, and retract.A test guidewire (0.014") was inserted and no indication of resistance in tracking the guidewire into the catheter was noted.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

Same case as mdr id# 2134265-2017-06271.It was reported that tip detachment occurred.The target lesion was located in the iliac vein.After a 5f sheath was inserted and a v-18 control wire crossed the lesion, an opticross¿ 18 imaging catheter was advanced.However, during the procedure, the catheter sheared off or detached at the guide wire lumen.The device remained intact.The device was removed and another opticross¿ 18 imaging catheter was advanced but the same thing happened.The procedure was completed with the third imaging catheter.No patient complications were reported and the patient's status was good.

• Brand Name: OPTICROSS¿ 18
• 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 Key: 6661255
• MDR Text Key: 78252573
• Report Number: 2134265-2017-06272
• Device Sequence Number: 1
• Product Code: ITX
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: TBD
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 06/05/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/22/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 03/08/2019
• Device Model Number: H7493932800180
• Device Lot Number: 20379344
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/09/2017
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 06/27/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/09/2017
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1