MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION OPTICROSS 18; CATHETER, ULTRASOUND, INTRAVASCULAR

Model Number 44021

Device Problem Entrapment of Device (1212)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 07/30/2018

Event Type  malfunction  

Manufacturer Narrative

Age at time of event - 18 years.Device not returning.

Event Description

It was reported that the catheter became stuck in stent occurred.The 70% stenosed target lesion was located in the moderately tortuous, severely calcified, 8mm in diameter and 6 mm inner diameter left external iliac artery.After an epic stent was deployed, an opticross imaging catheter was advanced to view the lesion; however, the tip of the catheter was stuck inside the stent.It was also reported that the stent was not fully apposition and the lesion was not fully dilated without post dilatation when the stuck occurred.Subsequently, the opticross imaging catheter was fully removed from the patient's body.The stent was observed to be damage-free and has been deployed inside the patient and the procedure was completed.No patient complications were reported and patient's status is good.

• Brand Name: OPTICROSS 18
• Type of Device: CATHETER, ULTRASOUND, INTRAVASCULAR
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; two scimed place; maple grove MN 55311
• Manufacturer (Section G): BOSTON SCIENTIFIC DE COSTA RICA S.R.L.; 2546 calle primera; propark, coyol; alajuela ; CS
• Manufacturer Contact: sonali arangil ; two scimed place; maple grove, MN 55311 ; 6515827403
• MDR Report Key: 7842983
• MDR Text Key: 119114353
• Report Number: 2134265-2018-60437
• Device Sequence Number: 1
• Product Code: ITX
• Combination Product (y/n): N
• Reporter Country Code: JA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 09/04/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/04/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 05/24/2020
• Device Model Number: 44021
• Device Catalogue Number: 44021
• Device Lot Number: 0022172221
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/12/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/25/2018
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1