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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ROTAWIRE AND WIRECLIP TORQUER; CATHETER, CORONARY, ATHERECTOMY
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ROTAWIRE AND WIRECLIP TORQUER; CATHETER, CORONARY, ATHERECTOMY Back to Search Results
Model Number 3520
Device Problems Entrapment of Device (1212); Use of Device Problem (1670)
Patient Problems No Consequences Or Impact To Patient (2199); No Clinical Signs, Symptoms or Conditions (4582)
Event Date 05/04/2020
Event Type  malfunction  
Manufacturer Narrative
(b)(6).
 
Event Description
It was reported that the burr was stuck with the wire.The 70% stenosed target lesion area was located in a moderately tortuous and moderately calcified left anterior descending artery.A 1.25mm rotalink plus and 330 cm rotawire were selected for use.The burr was successfully tested outside the body.During the procedure, the burr was advanced on the distal part of the wire.However, the burr was stuck and could not advance nor be pulled.The rotalink and rotawire was retrieved as a system.The procedure was completed with another of the same device.No complications reported and the patient was stable post procedure.
 
Manufacturer Narrative
H6: device code correction: added code - use of device problem.E1: additional initial reporter: (b)(6).
 
Event Description
It was reported that the burr was stuck with the wire.The 70% stenosed target lesion area was located in the moderately tortuous and moderately calcified left anterior descending artery.A 330cm gw(1pk) flop rotawire and wireclip was selected for a rotablator.The burr has been successfully tested outside the body.However, during procedure, when the burr was advanced on the distal part of the wire it was noted that the burr was stuck and could not advance nor be pulled.The rotalink and rotawire was retrieved as a system.The procedure was completed with another of the same device.No patient complications reported and patient was stable post procedure.
 
Manufacturer Narrative
B3: date of event: updated to (b)(6) 2020.E1: additional initial reporter: dr.(b)(6).
 
Event Description
It was reported that the burr was stuck with the wire.The 70% stenosed target lesion area was located in the moderately tortuous and moderately calcified left anterior descending artery.A 330cm gw(1pk) flop rotawire and wireclip was selected for a rotablator.The burr has been successfully tested outside the body.However, during procedure, when the burr was advanced on the distal part of the wire it was noted that the burr was stuck and could not advance nor be pulled.The rotalink and rotawire was retrieved as a system.The procedure was completed with another of the same device.No patient complications reported and patient was stable post procedure.
 
Manufacturer Narrative
B3: date of event: updated to (b)(6) 2020.E1: additional initial reporter: dr (b)(6).Device evaluated by mfr: the device was returned for evaluation.Microscopic and visual inspection of the device found kinks 139cm and 141.5cm from the proximal end of the wire.The returned rotawire was not able to be removed from the returned rotablator device due to the severe kinks in the wire.Dimensional inspection revealed the components were within specification.
 
Event Description
It was reported that the burr was stuck with the wire.The 70% stenosed target lesion area was located in the moderately tortuous and moderately calcified left anterior descending artery.A 330cm gw(1pk) flop rotawire and wireclip was selected for a rotablator.The burr has been successfully tested outside the body.However, during procedure, when the burr was advanced on the distal part of the wire it was noted that the burr was stuck and could not advance nor be pulled.The rotalink and rotawire was retrieved as a system.The procedure was completed with another of the same device.No patient complications reported and patient was stable post procedure.
 
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Brand Name
ROTAWIRE AND WIRECLIP TORQUER
Type of Device
CATHETER, CORONARY, ATHERECTOMY
MDR Report Key10367883
MDR Text Key201734791
Report Number2134265-2020-10478
Device Sequence Number1
Product Code MCX
UDI-Device Identifier08714729185871
UDI-Public08714729185871
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,Followup
Report Date 11/04/2021
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 Date06/28/2020
Device Model Number3520
Device Catalogue Number3520
Device Lot Number0022320584
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer10/01/2021
Initial Date Manufacturer Received 07/21/2020
Initial Date FDA Received08/05/2020
Supplement Dates Manufacturer Received07/29/2020
08/21/2020
10/26/2021
Supplement Dates FDA Received08/19/2020
08/28/2020
11/04/2021
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured06/29/2018
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 Age80 YR
Patient Weight85
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