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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION ROTAWIRE AND WIRECLIP TORQUER; CATHETER, CORONARY, ATHERECTOMY
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BOSTON SCIENTIFIC CORPORATION ROTAWIRE AND WIRECLIP TORQUER; CATHETER, CORONARY, ATHERECTOMY Back to Search Results
Model Number 3520
Device Problem Unsealed Device Packaging (1444)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 11/01/2018
Event Type  malfunction  
Event Description
It was reported that the device was not well packed and the plastic package was not firmly sealed when unpacking.A 330 cm rotawire was selected used.During unpacking, it was reported that the device was not well packed and the plastic package was not firmly sealed.There were no patient complications reported.Patient condition is stable.
 
Manufacturer Narrative
Device evaluated by mfr: the device was returned for analysis.Visual inspection revealed that the device has its distal tip kinked.The pouch is open but it has the marks of glue; since the marks of glue are evidence of a complete seal before opening, the complaint cannot be confirm.Dimensional inspection revealed that the overall length, the outer diameter of the distal tip, middle of the device and proximal section of the device were within specification.
 
Event Description
It was reported that the device was not well packed and the plastic package was not firmly sealed when unpacking.A 330 cm rotawire was selected used.During unpacking, it was reported that the device was not well packed and the plastic package was not firmly sealed.There were no patient complications reported.Patient condition is stable.
 
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Brand Name
ROTAWIRE AND WIRECLIP TORQUER
Type of Device
CATHETER, CORONARY, ATHERECTOMY
Manufacturer (Section D)
BOSTON SCIENTIFIC CORPORATION
two scimed place
maple grove MN 55311
MDR Report Key8075200
MDR Text Key127347291
Report Number2134265-2018-62958
Device Sequence Number1
Product Code MCX
UDI-Device Identifier08714729195566
UDI-Public08714729195566
Combination Product (y/n)N
PMA/PMN Number
P900056
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Type of Report Initial,Followup
Report Date 01/09/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received11/15/2018
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Expiration Date10/17/2019
Device Model Number3520
Device Catalogue Number3520
Device Lot Number0021269483
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer12/11/2018
Date Manufacturer Received12/21/2018
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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