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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BOSTON SCIENTIFIC - CORK ROTALINK¿ PLUS; CATHETER, CORONARY, ATHERECTOMY
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BOSTON SCIENTIFIC - CORK ROTALINK¿ PLUS; CATHETER, CORONARY, ATHERECTOMY Back to Search Results
Model Number H749236310040
Device Problem Torn Material (3024)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 02/15/2018
Event Type  malfunction  
Manufacturer Narrative
(b)(4).
 
Event Description
It was reported that the sheath was detached.The target lesion was located in the moderately tortuous and moderately calcified coronary artery.A 1.75mm rotalink¿ plus was selected for use.During the procedure, when the burr was used at the 7th ablation, it was noted that the rotation speed decreased by about 10,000rpm in an area which is not the target lesion and an unusual sound was heard.When the burr was removed from the body, it was further noted that the sheath part became detached.Since the target lesion was already ablated the procedure was completed with this device.No patient complications were reported.
 
Manufacturer Narrative
Device evaluated by mfr., eval summary attached, method codes, result codes, conclusion codes updated.Device evaluated by manufacturer: the device was returned for analysis.The handshake connection, sheath and coil were microscopically and visually examined.The rotawire was removed from the burr catheter.The sheath is torn 24.3cm from the strain relief.The fractured/separated ends of the sheath were stretched and jagged which indicates the shaft separation was due to tensile forces.Inspection of the remainder of the device presented no other damage or irregularities.The investigation conclusion is operational context as the product meets the design & manufacture specification but due to anatomical/procedural factors encountered during the procedure, performance was limited.(b)(4).
 
Event Description
It was reported that the sheath was detached.The target lesion was located in the moderately tortuous and moderately calcified coronary artery.A 1.75mm rotalink¿ plus was selected for use.During the procedure, when the burr was used at the 7th ablation, it was noted that the rotation speed decreased by about 10,000rpm in an area which is not the target lesion and an unusual sound was heard.When the burr was removed from the body, it was further noted that the sheath part became detached.Since the target lesion was already ablated the procedure was completed with this device.No patient complications were reported.
 
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Brand Name
ROTALINK¿ PLUS
Type of Device
CATHETER, CORONARY, ATHERECTOMY
Manufacturer (Section D)
BOSTON SCIENTIFIC - CORK
business and technology park
model farm road
cork
EI 
Manufacturer (Section G)
BOSTON SCIENTIFIC - CORK
business and technology park
model farm road
cork
EI  
Manufacturer Contact
sonali arangil
one scimed place
maple grove, MN 55311
7634941700
MDR Report Key7333673
MDR Text Key102212860
Report Number2134265-2018-01744
Device Sequence Number1
Product Code MCX
UDI-Device Identifier08714729228370
UDI-Public08714729228370
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
Reporter Occupation Physician
Type of Report Initial,Followup
Report Date 02/19/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received03/13/2018
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Expiration Date10/21/2019
Device Model NumberH749236310040
Device Catalogue Number23631-004
Device Lot Number21409176
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer02/22/2018
Is the Reporter a Health Professional? Yes
Date Manufacturer Received03/29/2018
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured11/20/2017
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
Treatment
BALLOON CATHETER: TAZUNA/ TERUMO; GUIDE CATHETER: LAUNCHER/ MDT; GUIDEWIRE: ROTAWIRE/BSJ; STENT: XIENCE/AVJ
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