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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BOSTON SCIENTIFIC - CORK ROTALINK? BURR; CATHETER, CORONARY, ATHERECTOMY

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BOSTON SCIENTIFIC - CORK ROTALINK? BURR; CATHETER, CORONARY, ATHERECTOMY Back to Search Results
Model Number H802227680020
Device Problem Connection Problem (2900)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 12/08/2014
Event Type  malfunction  
Event Description
Same case as: 2134265-2015-00848.Reportable based on device analysis completed on 29jan2015.It was reported that a burr catheter connection was kinked.A 1.25mm rotalink¿ burr and a rotawire were selected to treat the target lesion.During the procedure, outside the patient, it was noted that the burr catheter connection was kinked which was connected to the advancer.The procedure was completed with another of the same device.No patient complications were reported and the patient's status was stable.However, device analysis revealed that a guide wire could not be removed from the burr.
 
Manufacturer Narrative
Age at time of event: 18 years or older.Device evaluated by mfr.: the device was returned for analysis.A visual examination of the complaint unit was carried out and no issues were noted.The handshake connection was inspected and no damage was noted.The coil proximal to the handshake connection was observed to be kinked.A guide wire was returned running through the device.An attempt was made to remove the guide wire but a resistance was felt, possibly due to the kink in the coil and the guide wire could not be removed.The manufacturing batch record review confirmed that the device met all material, assembly and performance specifications.The most probable root cause is considered handling damage as the event occurred without direct patient contact.(b)(4).
 
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Brand Name
ROTALINK? BURR
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
linda leimer
one scimed place
maple grove, MN 55311
7634941700
MDR Report Key4545739
MDR Text Key5518472
Report Number2134265-2015-00718
Device Sequence Number1
Product Code MCX
Combination Product (y/n)N
Reporter Country CodeCN
PMA/PMN Number
P900056
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Foreign,Health Professional,Company Representative,Distributor
Reporter Occupation Physician
Type of Report Initial
Report Date 01/29/2015
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 Date02/29/2016
Device Model NumberH802227680020
Device Catalogue Number22768-002
Device Lot Number0016839038
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer01/13/2015
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 01/29/2015
Initial Date FDA Received02/25/2015
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured03/26/2014
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
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