MAUDE Adverse Event Report: BOSTON SCIENTIFIC - FREMONT (SUD) ULTRASONIC IMAGING CATHETER - CORONARY; CATHETER, INTRAVASCULAR, DIAGNOSTIC

Model Number UNK97

Device Problem Retraction Problem (1536)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Type  malfunction  

Event Description

Same case as: 2134265-2014-07747 and 2134265-2014-07877.It was reported that automatic pullback failure occurred.A 100v galaxy 2 intravascular ultrasound system was used in conjunction with an unspecified coronary imaging catheter to visualize an unspecified lesion.During the procedure, the physician verbalized that automatic pullback movement was bad and was eventually stopped after it was checked.And so, automatic pullback failure occurred.The physician then performed manual pullback to complete the procedure.No patient complications were reported and the patient's status is stable.

Manufacturer Narrative

(b)(4).The complaint device was not available for evaluation; therefore, product inspection could not be performed.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: ULTRASONIC IMAGING CATHETER - CORONARY
• Type of Device: CATHETER, INTRAVASCULAR, 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: 4334504
• MDR Text Key: 5138600
• Report Number: 2134265-2014-07873
• Device Sequence Number: 1
• Product Code: DQO
• Combination Product (y/n): N
• PMA/PMN Number: UNKNOWN
• 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: 11/27/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/16/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: UNK97
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/27/2014
• 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
• Type of Device Usage: Initial
• Patient Sequence Number: 1