MAUDE Adverse Event Report: BOSTON SCIENTIFIC - FREMONT (SUD) ATLANTIS¿ SR PRO²; CATHETER, INTRAVASCULAR, DIAGNOSTIC

Model Number H749390140

Device Problem Device Markings/Labelling Problem (2911)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 10/13/2015

Event Type  malfunction  

Manufacturer Narrative

(b)(4).

Event Description

It was reported that one of the imaging catheter marker bands was missing.During an intravascular ultrasound (ivus), an atlantis¿ sr pro² imaging catheter was selected.It was noted that the connection between the parts at the proximal end of the atlantis¿ sr pro² imaging catheter were loose.It was further reported that one of the two markers on the imaging catheter was missing.The procedure was completed with another of the same device.No serious injury was reported and the patient status is stable.

Manufacturer Narrative

Corrected: describe event or problem the device was returned for evaluation.Evaluation of the returned device revealed that the telescope male tubing was found detached from the hub assembly.A kink was observed in the sheath assembly from femoral marker to the proximal end.Full image characterization cannot be performed due to the telescope detached.The manufacturing batch record review confirmed that the device met all material, assembly and performance specifications.The root cause is not confirmed as there was no evidence of the alleged issue or any anomalies which could have contributed to the reported difficulty.(b)(4).

Event Description

It was previously reported that one of the two markers on the imaging catheter was missing; however, this report is correcting that one of the two markers on the imaging catheter was unable to be visualized.

• Brand Name: ATLANTIS¿ SR PRO²
• 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: 5205449
• MDR Text Key: 30570647
• Report Number: 2134265-2015-07617
• Device Sequence Number: 1
• Product Code: DQO
• Combination Product (y/n): N
• PMA/PMN Number: K063312
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 10/14/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/05/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 07/05/2016
• Device Model Number: H749390140
• Device Catalogue Number: 39014
• Device Lot Number: 18150414
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/21/2015
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/05/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/06/2015
• 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
• Patient Age: 60 YR