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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION PERIPHERAL ROTAWIRE AND WIRECLIP TORQUER; CATHETER, PERIPHERAL, ATHERECTOMY
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BOSTON SCIENTIFIC CORPORATION PERIPHERAL ROTAWIRE AND WIRECLIP TORQUER; CATHETER, PERIPHERAL, ATHERECTOMY Back to Search Results
Model Number 29710
Device Problem Detachment of Device or Device Component (2907)
Patient Problem Device Embedded In Tissue or Plaque (3165)
Event Date 08/20/2019
Event Type  Injury  
Event Description
It was reported that the spring tip broke.The target lesion was located in a small collateral branch.A peripheral rotawire was selected for use.During procedure, it was noted that the spring tip was broken.The distal tip of the wire was left inside the patient's body and was not snared as it was located in a small branch.It was not attempted to be retrieved and no intervention was done.No complications manifested to the patient.
 
Manufacturer Narrative
Device evaluated by mfr: the device was returned for evaluation.Visual inspection revealed that the device has the distal tip broken/fractured approximately at 328.4 cm from the proximal end; the detached section was not returned.The guidewire body was kinked approximately at 236 cm from the proximal end.No more damages were found.Dimensional inspection revealed that the overall length and outer diameter (od) of the distal tip could not be performed due to device condition.The od of the middle and proximal section of the deice were within specifications.
 
Event Description
It was reported that the spring tip broke.The target lesion was located in a small collateral branch.A peripheral rotawire was selected for use.During procedure, it was noted that the spring tip was broken.The distal tip of the wire was left inside the patient's body and was not snared as it was located in a small branch.It was not attempted to be retrieved and no intervention was done.No complications manifested to the patient.
 
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Brand Name
PERIPHERAL ROTAWIRE AND WIRECLIP TORQUER
Type of Device
CATHETER, PERIPHERAL, ATHERECTOMY
Manufacturer (Section D)
BOSTON SCIENTIFIC CORPORATION
two scimed place
maple grove MN 55311
MDR Report Key9010602
MDR Text Key158202795
Report Number2134265-2019-11066
Device Sequence Number1
Product Code MCW
UDI-Device Identifier08714729863649
UDI-Public08714729863649
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,health
Type of Report Initial,Followup
Report Date 10/16/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model Number29710
Device Catalogue Number29710
Device Lot Number0023933983
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer09/16/2019
Initial Date Manufacturer Received 08/21/2019
Initial Date FDA Received09/12/2019
Supplement Dates Manufacturer Received09/23/2019
Supplement Dates FDA Received10/16/2019
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Outcome(s) Other;
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