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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 Device Contamination with Chemical or Other Material (2944)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 06/09/2021
Event Type  malfunction  
Manufacturer Narrative
(b)(6).
 
Event Description
It was reported that debris was observed on the rotawire.The 90% stenosed target lesion was located in the mildly tortuous and severely calcified left anterior descending artery.A rotawire was selected for use.During removal of the device, it was noted that a lump was present at the junction of distal tip and the shaft of the wire.Some debris were also observed.The device was removed using a non bsc microcatheter and the procedure was completed using the original device.No patient complications were reported.
 
Event Description
It was reported that debris was observed on the rotawire.The 90% stenosed target lesion was located in the mildly tortuous and severely calcified left anterior descending artery.A rotawire was selected for use.During removal of the device, it was noted that a lump was present at the junction of distal tip and the shaft of the wire.Some debris were also observed.The device was removed using a non bsc microcatheter and the procedure was completed using the original device.No patient complications were reported.It was further reported that there was a white material observed on the wire.
 
Manufacturer Narrative
E1 - initial reporter city: (b)(6).
 
Event Description
It was reported that debris was observed on the rotawire.The 90% stenosed target lesion was located in the mildly tortuous and severely calcified left anterior descending artery.A rotawire was selected for use.During removal of the device, it was noted that a lump was present at the junction of distal tip and the shaft of the wire.Some debris were also observed.The device was removed using a non bsc microcatheter and the procedure was completed using the original device.No patient complications were reported.It was further reported that there was a white material observed on the wire.
 
Manufacturer Narrative
E1 - initial reporter city: (b)(6).Device evaluated by mfr.: the complaint device was returned for analysis.Visual inspection, both the body and the spring tip of the guidewire were carefully inspected and no abnormalities were observed, they were smooth and uniform and no foreign matters were detected.A white small material was returned within a peri dish, this white material is consistent with the coated thin film of lubricant part of the rotawire.Analysis of pictures attached by the customer revealed a foreign matter in the spring tip of the device; consequently, confirming the reported complaint; however, it was not present when returned to the cis.Additionally, this white material observed on the wire is consistent with the coated thin film of lubricant part of the rotawire.
 
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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 Key12085481
MDR Text Key258970660
Report Number2134265-2021-08147
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,distri
Type of Report Initial,Followup,Followup
Report Date 08/25/2021
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 Date12/18/2022
Device Model Number3520
Device Catalogue Number3520
Device Lot Number0026542547
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer07/20/2021
Initial Date Manufacturer Received 06/11/2021
Initial Date FDA Received06/29/2021
Supplement Dates Manufacturer Received07/12/2021
08/10/2021
Supplement Dates FDA Received07/14/2021
08/25/2021
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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