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

Model Number H7493932800180

Device Problem Detachment of Device or Device Component (2907)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 05/08/2017

Event Type  malfunction  

Manufacturer Narrative

(b)(4).

Event Description

It was reported that a catheter tip separation occurred during a venogram procedure, an opticross¿ imaging catheter was selected to view the target lesion located at the iliac vein.During the procedure it was noticed that the tip of first opticross¿ imaging catheter broke inside the patient's body while going over the bifurcation lesion, however, upon checking they noticed that the catheter was just separated like a snapped in half.The whole catheter was removed from the patient's body as one unit.To continue with the procedure they pulled the second opticross¿ imaging catheter to use they plugged it but they were unable to adjust any of the setting on the screen.They tried to unplug the catheter and plugged it back still settings could not be adjusted.They had to reboot and turned the console off then reboot it again plugged in the additional catheter then it worked.The procedure was completed using a different device.No patient complications were reported.

Manufacturer Narrative

Device evaluated by mfr: the device was returned for analysis.Device analysis revealed a damage in the distal tip portion.The flush testing cannot be performed based on the returned condition of the catheter.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 catheter tip separation occurred during a venogram procedure, an opticross imaging catheter was selected to view the target lesion located at the iliac vein.During the procedure it was noticed that the tip of first opticross imaging catheter broke inside the patient's body while going over the bifurcation lesion, however, upon checking they noticed that the catheter was just separated like a snapped in half.The whole catheter was removed from the patient's body as one unit.To continue with the procedure they pulled the second opticross imaging catheter to use they plugged it but they were unable to adjust any of the setting on the screen.They tried to unplug the catheter and plugged it back still settings could not be adjusted.They had to reboot and turned the console off then reboot it again plugged in the additional catheter then it worked.The procedure was completed using a different device.No patient complications were reported.

• 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: 6581496
• MDR Text Key: 75723921
• Report Number: 2134265-2017-05283
• 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: 05/09/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 03/08/2019
• Device Model Number: H7493932800180
• Device Lot Number: 20379118
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/12/2017
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 05/09/2017
• Initial Date FDA Received: 05/22/2017
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 06/06/2017
• 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