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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BOSTON SCIENTIFIC - SAN JOSE FILTERWIRE EZ?; TEMPORARY CORONARY SAPHENOUS VEIN BYPASS GRAFT FOR EMBOLIC PROTECTION
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BOSTON SCIENTIFIC - SAN JOSE FILTERWIRE EZ?; TEMPORARY CORONARY SAPHENOUS VEIN BYPASS GRAFT FOR EMBOLIC PROTECTION Back to Search Results
Model Number H749201051900
Device Problems Break (1069); Device Damaged Prior to Use (2284)
Patient Problem No Patient Involvement (2645)
Event Date 09/26/2014
Event Type  malfunction  
Event Description
It was reported that the part that connected the tube and loop was broken.A 190cm filterwire ez¿ was selected for use.During preparation, it was noted that the part that connected the tube and loop was broken.The procedure was not completed due to this event.No patient complications reported and the patient's status was stable.
 
Manufacturer Narrative
Device evaluated by mfr.: the device was returned for analysis.During the visual and microscopic examination of the returned device, the distal tip of the protection wire was found to be normal and overall in good condition.It was not damaged or stretched.The filter bag was found deployed, the filter was found inverted, and the loop legs were found broken, but still attached to the device.The break was not found at a bond or joint.The break appears clean, with no jagged edges.No trace of blood was found on the inside of the device.170 cm of the protection wire was found exposed, where the slit begins at 6.9 cm from the distal end of the delivery sheath.The wire was found kinked approximately at 15.5 cm, when measured from the distal tip of the protection wire.The sheath was found kinked approximately at 148 cm, when measured from the distal tip of the delivery sheath.The cis technician was unable to perform the sheathing/unsheathing test due to the broken loop legs.The filter bag was observed to be in good condition and met specification.The peel away test was also performed successfully, no anomalies were observed.The manufacturing batch record review confirmed that the device met all material, assembly and performance specifications.The most probable root cause is considered handling damage as the event occurred without direct patient contact.(b)(4).
 
Event Description
It was reported that the part that connected the tube and loop was broken.A 190cm filterwire ez¿ was selected for use.During preparation, it was noted that the part that connected the tube and loop was broken.The procedure was not completed due to this event.No patient complications reported and the patient's status was stable.
 
Manufacturer Narrative
(b)(4).
 
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Brand Name
FILTERWIRE EZ?
Type of Device
TEMPORARY CORONARY SAPHENOUS VEIN BYPASS GRAFT FOR EMBOLIC PROTECTION
Manufacturer (Section D)
BOSTON SCIENTIFIC - SAN JOSE
150 baytech drive
san jose CA 95134
Manufacturer (Section G)
BOSTON SCIENTIFIC - SAN JOSE
150 baytech drive
san jose CA 95134
Manufacturer Contact
linda leimer
one scimed place
maple grove, MN 55311
7634941700
MDR Report Key4188867
MDR Text Key5224177
Report Number2134265-2014-06522
Device Sequence Number1
Product Code NFA
Combination Product (y/n)N
Reporter Country CodeTW
PMA/PMN Number
K061332
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 09/26/2014
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received10/21/2014
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Expiration Date05/06/2016
Device Model NumberH749201051900
Device Catalogue Number20105-190
Device Lot Number16951565
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer10/14/2014
Is the Reporter a Health Professional? Yes
Date Manufacturer Received10/29/2014
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured05/08/2014
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
Patient Age83 YR
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