MAUDE Adverse Event Report: BOSTON SCIENTIFIC - COSTA RICA (COYOL) ATLANTIS? SR PRO²; CATHETER, INTRAVASCULAR, DIAGNOSTIC

Model Number H749390140

Device Problem Retraction Problem (1536)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 12/02/2014

Event Type  malfunction  

Event Description

Same case as 2134265-2014-08337 and 2134265-2014-08338.It was reported that automatic pullback failure occurred.The motor drive unit (mdu) was used in conjunction with an atlantis¿ sr pro imaging catheter and a sled.When performing pullback, the mdu did not perform automatic pullback.No patient complications was reported.

Event Description

Same case as 2134265-2014-08337 and 2134265-2014-08338.It was reported that automatic pullback failure occurred.The motor drive unit (mdu) was used in conjunction with an atlantis¿ sr pro imaging catheter and a sled.When performing pullback, the mdu did not perform automatic pullback.No patient complications was reported.

Manufacturer Narrative

(b)(4).

Manufacturer Narrative

Device evaluated by manufacturer: the complaint device was received for evaluation.Device analysis revealed no issues found and appears to be in good condition.The telescope assembly was able to properly pull back, advance, and retract.The unit was correctly recognized by the imaging system.Impedance testing shows a good unit wave form.During image characterization testing, a good square image appeared in the ilab system.No issues or defects were observed during product analysis of the returned device.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).

• Brand Name: ATLANTIS? SR PRO²
• 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: 4355368
• MDR Text Key: 5177127
• Report Number: 2134265-2014-08346
• Device Sequence Number: 1
• Product Code: DQO
• Combination Product (y/n): N
• Reporter Country Code: GB
• 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,Followup
• Report Date: 12/02/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/23/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: H749390140
• Device Catalogue Number: 39014
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/17/2014
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/03/2015
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1