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

Model Number H749518050

Device Problem Retraction Problem (1536)

Patient Problem No Patient Involvement (2645)

Event Date 11/11/2014

Event Type  malfunction  

Event Description

Same case as: 2134265-2014-07368, 2134265-2014-07591.It was reported that automatic pullback failure occurred.An ilab ultrasound imaging system was used in conjunction with an icross¿ imaging catheter in order to visualize an unknown target lesion.During intravascular ultrasound (ivus) automatic pullback did not work.The physician tried to test the catheter and sled outside the patient's body but same issue occurred.The procedure was completed with this device by manual pullback.No patient complications were reported.

Manufacturer Narrative

Device evaluated by mfr: the device has not been received for analysis.Upon receipt and completion of the failure analysis of the complaint device, if there is any further relevant information from that review, a supplemental medwatch will be filed.(b)(4).

• Brand Name: ICROSS?
• 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: 4301739
• MDR Text Key: 5084715
• Report Number: 2134265-2014-07592
• Device Sequence Number: 1
• Product Code: DQO
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K063312
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 11/11/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/05/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: H749518050
• Device Catalogue Number: 51805
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/11/2014
• 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