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

Model Number H749389420

Device Problem Device Markings/Labelling Problem (2911)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 02/07/2014

Event Type  malfunction  

Event Description

It was reported that marker bands on catheter were malpositioned.The atlantis sr pro was used during unspecified procedure and the physician noticed that the marker bands were incorrectly placed.The procedure was completed with another with same device.No patient complications were reported.

Manufacturer Narrative

(b)(4).

Manufacturer Narrative

Device evaluated by mfr: the complaint device was returned for evaluation.A kink was observed in the sheath assembly at 4.0 cm from femoral marker to the proximal end.The telescope assembly was not able to properly pull back, advance, or retract.During image characterization testing, no image appeared in the system due to electrical open at distal.The white marker band was found completely intact and visible in corrected location on the shaft.The distance from the distal end of the transducer housing to the distal edge of the ro marker measured 5.5 mm.The observed distance is within specification.The distance from the distal tip to the femoral marker was measured as 109.8 cm.The observed distance is not within specification.The imaging window has a flatten section and appears to be about 5 cm longer then specification.The manufacturing batch record review confirmed that the device met all material, assembly and performance specifications.The most probable root cause was unable to be determined.(b)(4).

Event Description

It was reported that marker bands on catheter were malpositioned.The atlantis¿ sr pro was used during unspecified procedure and the physician noticed that the marker bands were incorrectly placed.The procedure was completed with another with same device.No patient complications were reported.

• Brand Name: ATLANTIS? SR PRO
• 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: ingrid matte ; one scimed place; maple grove, MN 55311 ; 7634941700
• MDR Report Key: 3663766
• MDR Text Key: 17931111
• Report Number: 2134265-2014-01100
• 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,Followup
• Report Date: 02/07/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/06/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 11/22/2014
• Device Model Number: H749389420
• Device Catalogue Number: 38942
• Device Lot Number: 16559751
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/19/2014
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 05/05/2014
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/22/2013
• 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