MAUDE Adverse Event Report: BOSTON SCIENTIFIC - COSTA RICA (COYOL) ULTRA ICE¿; TRANSDUCER, ULTRASONIC, DIAGNOSTIC

Model Number M00499000

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Hematoma (1884)

Event Date 06/27/2018

Event Type  Injury  

Manufacturer Narrative

It was indicated that the device will not be returned for evaluation.If any further information is obtained, a supplemental medwatch will be filed.(b)(4).

Event Description

It was reported that a hematoma occurred at the access site.It was reported that during a watchman implant procedure, while attempting to insert an ultra ice ultrasonic imaging catheter via the patient¿s left leg, it was difficult to obtain access and the catheter was then successfully inserted on the right side of the patient.Approximately 3-4 hours post-procedure the patient developed a hematoma on the left leg at the attempted access site for the ultra ice catheter.Pressure was applied to the hematoma, but it did not resolve and it was necessary to perform a drainage procedure.The watchman had been successfully implanted and the patient was discharged from the hospital after a couple of days.The patient was reported to be ¿fine".

• Brand Name: ULTRA ICE¿
• Type of Device: TRANSDUCER, ULTRASONIC, DIAGNOSTIC
• 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: 7693434
• MDR Text Key: 114145217
• Report Number: 2134265-2018-06518
• Device Sequence Number: 1
• Product Code: ITX
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K902245
• 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
• Report Date: 06/27/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/17/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: M00499000
• Device Catalogue Number: 9900
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 06/27/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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): Required Intervention
• Patient Age: 64 YR