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U.S. Department of Health and Human Services

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

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BOSTON SCIENTIFIC - FREMONT (SUD) ATLANTIS? SR PRO²; CATHETER, INTRAVASCULAR, DIAGNOSTIC Back to Search Results
Model Number H749390140
Device Problem Hole In Material (1293)
Patient Problem No Patient Involvement (2645)
Event Date 03/06/2014
Event Type  malfunction  
Event Description
It was reported that a hole was found on the catheter.During a percutaneous coronary intervention, the 90% stenosed target lesion was located in a moderately calcified and moderately tortuous middle left anterior descending coronary artery.An atlantis sr pro² imaging catheter was used in conjunction with a motor drive unit to view the lesion.During preparation, a hole was noticed on the connecting plastic portion of the imaging catheter.The procedure was completed with another of the same device.No patient complications were reported and the patient's status is good.
 
Manufacturer Narrative
Age at time of event: 18 years or older.(b)(4).
 
Manufacturer Narrative
Device returned to mfr: the device was returned for evaluation.Examination of the returned device revealed that the hub flaps appeared normal and a good click sound was heard during insertion into the mdu system.Fluid was leaking at the male/female luer connection was connected when the catheter was flushed.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 was unable to be determined.(b)(4).
 
Event Description
It was reported that a hole was found on the catheter.During a percutaneous coronary intervention, the 90% stenosed target lesion was located in a moderately calcified and moderately tortuous middle left anterior descending coronary artery.An atlantis¿ sr pro² imaging catheter was used in conjunction with a motor drive unit to view the lesion.During preparation, a hole was noticed on the connecting plastic portion of the imaging catheter.The procedure was completed with another of the same device.No patient complications were reported and the patient's status is good.
 
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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
ingrid matte
one scimed place
maple grove, MN 55311
7634941700
MDR Report Key3726104
MDR Text Key4328556
Report Number2134265-2014-01804
Device Sequence Number1
Product Code DQO
Combination Product (y/n)N
PMA/PMN Number
K063312
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Foreign,Health Professional,Company Representative,Distributor
Reporter Occupation Physician
Type of Report Initial,Followup
Report Date 03/06/2014
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 Date09/12/2014
Device Model NumberH749390140
Device Catalogue Number39014
Device Lot Number16376478
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer03/11/2014
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 05/22/2014
Initial Date FDA Received04/03/2014
Supplement Dates Manufacturer ReceivedNot provided
Supplement Dates FDA Received06/17/2014
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured09/12/2013
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
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