MAUDE Adverse Event Report: BOSTON SCIENTIFIC - COSTA RICA (COYOL) ATLANTIS? SR PRO; CATHETER, INTRAVASCULAR, DIAGNOSTIC

Model Number H749389420

Device Problem Retraction Problem (1536)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 12/01/2014

Event Type  malfunction  

Event Description

Same case as 2134265-2014-07825, 2134265-2014-07867 and 2134265-2014-07868.It was reported that automatic pullback failure occurred.During an angioplasty procedure, a motor drive unit (mdu) was used in conjunction with an atlantis¿ sr pro imaging catheter to view an unspecified target lesion.Imaging was working fine when the test run was performed.The catheter was then inserted into the unspecified lesion.The catheter was parked at the intended site, imaging was switched on to confirm location.Then as 'pullback record' was pressed, the pullback does not work.Recording is underway - the 'frame' counter and the 'distance' counter progressed.It was noted that the pullback sled did not move.Another sled was then used but the same issue occurred with the catheter not pulling back.The physician performed manual pullback.Procedure was completed with another of the same device.No patient complications were reported and the patient's condition is stable.

Manufacturer Narrative

Age at time of event: 18 years or older.Device evaluated by manufacturer: the complaint device was not returned for evaluation.The batch number is unknown and the manufacturing records for the complaint device could not be reviewed.The most probable root cause was unable to be determined.(b)(4).

• Brand Name: ATLANTIS? SR PRO
• Type of Device: CATHETER, INTRAVASCULAR, 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: linda leimer ; one scimed place; maple grove, MN 55311 ; 7634941700
• MDR Report Key: 4337580
• MDR Text Key: 5144162
• Report Number: 2134265-2014-07866
• Device Sequence Number: 1
• Product Code: DQO
• Combination Product (y/n): N
• Reporter Country Code: MY
• PMA/PMN Number: K063312
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 12/01/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: H749389420
• Device Catalogue Number: 38942
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 12/01/2014
• Initial Date FDA Received: 12/17/2014
• 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
• Patient Sequence Number: 1