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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BOSTON SCIENTIFIC - FREMONT (SUD) ATLANTIS? 018; TRANSDUCER, ULTRASONIC, DIAGNOSTIC

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BOSTON SCIENTIFIC - FREMONT (SUD) ATLANTIS? 018; TRANSDUCER, ULTRASONIC, DIAGNOSTIC Back to Search Results
Model Number M001FG000240
Device Problem Material Deformation (2976)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 10/22/2014
Event Type  malfunction  
Event Description
Reportable based on investigation completed on 08dec2014.It was reported that the tip of the catheter was flattened or damaged.The 100% stenosed target lesion was located in the moderately tortuous and calcified superficial femoral artery.During a peripheral percutaneous intervention (ppi), an atlantis¿ 018 imaging catheter was used in order to visualize the target lesion.However, it was noted that the tip of the device was flattened or damaged.Subsequently, a non-bsc guide wire was unable to pass through the imaging catheter.The procedure was then completed using a different device.No patient complications were reported and the patient's status is good.However, after device analysis it was found out that the distal tip assembly was broken and missing.
 
Manufacturer Narrative
Age at the time of event: 18 years or older.(b)(4).The complaint device was received for evaluation.After device analysis, the following were observed: a kink was observed in the sheath assembly at 20.0cm from femoral marker to the distal end.The distal tip assembly was broken off and missing approximately 3.0mm long during investigation.The broken distal tip assembly appeared stretched and neckdown was observed at the ro marker distal end.During image characterization testing in the roller coaster model, a good square image appeared in the system and the product performed within specification.No other 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 most probable root cause is operational context as device performance was limited due to anatomical procedural factors.(b)(4).
 
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Brand Name
ATLANTIS? 018
Type of Device
TRANSDUCER, ULTRASONIC, 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 Key4358422
MDR Text Key20659607
Report Number2134265-2014-07962
Device Sequence Number1
Product Code ITX
Combination Product (y/n)N
PMA/PMN Number
K073623
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Foreign,Health Professional,Company Representative
Reporter Occupation Physician
Type of Report Initial
Report Date 12/08/2014
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Expiration Date04/04/2015
Device Model NumberM001FG000240
Device Catalogue NumberFG000-24
Device Lot Number16872560
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer11/04/2014
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 12/08/2014
Initial Date FDA Received12/23/2014
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured04/07/2014
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
Treatment
GUIDE WIRE: TREASURE XS (ST.JUDE MEDICAL); INTRODUCER SHEATH: DESTINATION (TERUMO)
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