MAUDE Adverse Event Report: BOSTON SCIENTIFIC - FREMONT (SUD) ATLANTIS¿ 018; TRANSDUCER, ULTRASONIC, DIAGNOSTIC

Model Number M001FG000240

Device Problem Entrapment of Device (1212)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 02/09/2016

Event Type  Injury  

Manufacturer Narrative

Device evaluated by manufacturer: the device was not returned for analysis.The manufacturing batch record review confirmed that the device met all material, assembly and performance specifications.The most probable root cause was unable to be determined.(b)(4).

Event Description

It was reported that the tip became stuck in the lesion.The 95% stenosed target lesion was located in the moderately tortuous and severely calcified left common iliac artery (cia).An atlantis¿ 018 was selected for use.During the procedure, it was noted that the tip was caught in the left cia.Due to the lost image issue, the device was unable to be used.The procedure was completed with another of the same device.No patient complications were reported and the patient's condition was stable.

• Brand Name: ATLANTIS¿ 018
• Type of Device: TRANSDUCER, ULTRASONIC, DIAGNOSTIC
• Manufacturer (Section D): BOSTON SCIENTIFIC - FREMONT (SUD); 47215 lakeview blvd phone; west dock; fremont CA 94538
• Manufacturer (Section G): BOSTON SCIENTIFIC - FREMONT (SUD); 47215 lakeview blvd phone; west dock; fremont CA 94538
• Manufacturer Contact: linda leimer ; one scimed place; maple grove, MN 55311 ; 7634941700
• MDR Report Key: 5483544
• MDR Text Key: 39776780
• Report Number: 2134265-2016-01436
• Device Sequence Number: 1
• Product Code: ITX
• Combination Product (y/n): N
• PMA/PMN Number: K073623
• 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
• Report Date: 02/09/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/07/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 07/20/2016
• Device Model Number: M001FG000240
• Device Catalogue Number: FG000-24
• Device Lot Number: 18216769
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/09/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/21/2015
• 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
• Treatment: GUIDING CATHETER: 6FR PARENT 108CM
• Patient Outcome(s): Other