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

Model Number H749305900180

Device Problem Retraction Problem (1536)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 05/30/2018

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

Same case as: 2134265-2018-05942 and 2134265-2018-05943.It was reported that automatic pullback failure occurred.The 85% stenosed target lesion was located in the moderately tortuous and mildly calcified iliac artery.During an endovascular treatment (evt) for iliac stenosis, an ilab ultrasound imaging system was used in conjunction with an opticross¿ imaging catheter and pullback sled to view the target lesion.When opticross 18 peripheral was used, the part to perform pullback was hard and it could not be moved.The procedure was completed with another opticross¿ imaging catheter.No patient complications were reported.

Manufacturer Narrative

Device evaluated by manufacturer: device was returned.Analysis of returned product revealed that the device does not present any visual damages or abnormalities that can cause imaging related issue.The catheter was functionally tested and was able to properly pull back manually and automatically, not connection issues or errors were detected.The impedance testing shows a good unit wave form.During image characterization testing, a good square image appeared in the ilab system.The investigation conclusion is not confirmed - returned as there was no evidence of either the alleged issue(s) or any defect which could have contributed to the event.(b)(4).

Event Description

Same case as 2134265-2018-05942 and 2134265-2018-05943.It was reported that automatic pullback failure occurred.The 85% stenosed target lesion was located in the moderately tortuous and mildly calcified iliac artery.During an endovascular treatment (evt) for iliac stenosis, an ilab ultrasound imaging system was used in conjunction with an opticross imaging catheter and pullback sled to view the target lesion.When opticross 18 peripheral was used, the part to perform pullback was hard and it could not be moved.The procedure was completed with another opticross imaging catheter.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: 7614542
• MDR Text Key: 111547588
• Report Number: 2134265-2018-05485
• Device Sequence Number: 1
• Product Code: ITX
• Combination Product (y/n): N
• PMA/PMN Number: N/A
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,distri
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 05/31/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/19/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 02/19/2020
• Device Model Number: H749305900180
• Device Catalogue Number: 30590-018
• Device Lot Number: 21763037
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/12/2018
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 07/04/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/19/2018
• 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