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

Model Number H7493932800180

Device Problems Detachment Of Device Component (1104); Entrapment of Device (1212)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 04/03/2017

Event Type  Injury  

Manufacturer Narrative

(b)(4).Device evaluated by mfr: the complaint device was not returned by the customer; therefore, no product analysis could be performed.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 catheter stuck in the lesion and tip detachment occurred.An opticross¿ 18 imaging catheter was selected for use.During an arterial intravascular ultrasound (ivus), it was noticed that the tip of the opticross¿ 18 imaging catheter was stuck at the bifurcation.While the physician was trying to advance the opticross¿ 18, the tip of the opticross¿ 18 became dislodged from the catheter.The physician removed the opticross¿ 18 imaging catheter and then retrieved the dislodged tip from the patient's body.The procedure was completed with this device.No patient complications were reported and the patient's status is okay.

Manufacturer Narrative

(b)(4).

Event Description

It was further reported that the dislodged catheter tip was snared out from the patient's body.

• 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: 6533489
• MDR Text Key: 74041677
• Report Number: 2134265-2017-03855
• 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: 04/03/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/01/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 02/15/2019
• Device Model Number: H7493932800180
• Device Lot Number: 20292748
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 05/01/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/16/2017
• 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
• Patient Outcome(s): Other; Required Intervention