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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION ROTALINK BURR; CATHETER, CORONARY, ATHERECTOMY

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BOSTON SCIENTIFIC CORPORATION ROTALINK BURR; CATHETER, CORONARY, ATHERECTOMY Back to Search Results
Model Number 3320
Device Problem Connection Problem (2900)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 09/25/2019
Event Type  malfunction  
Manufacturer Narrative
Age at time of event: 18 years or older.Device evaluated by manufacturer: the device was returned for analysis.The returned complaint device consisted of a rotablator rotalink burr catheter.The detached burr was not returned.The advancer, handshake connections, sheath and coil were microscopically and visually examined.The coil is stretched and broken 135.5cm from the strain relief.Inspection of the remainder of the device presented no other damage or irregularities.
 
Event Description
Reportable based on device analysis completed on 23dec2019.It was reported that the handshake connector broke away.The target lesion area was located in the left anterior descending artery.A 1.50mm rotalink burr was selected for use.During preparation, it was noted that the burr catheter broke away while connecting it to the advancer at the handshake connection.The procedure was completed with another of the same device.No patient complications were reported, and the patient was stable.However, the device analysis revealed that the coil was broken 135.5cm from the strain relief.
 
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Brand Name
ROTALINK BURR
Type of Device
CATHETER, CORONARY, ATHERECTOMY
Manufacturer (Section D)
BOSTON SCIENTIFIC CORPORATION
two scimed place
maple grove MN 55311
Manufacturer (Section G)
BOSTON SCIENTIFIC CORK LIMITED
model farm road
cork
EI  
Manufacturer Contact
jay johnson
two scimed place
maple grove, MN 55311
7634942574
MDR Report Key9581884
MDR Text Key177409561
Report Number2134265-2020-00066
Device Sequence Number1
Product Code MCX
UDI-Device Identifier08714729185857
UDI-Public08714729185857
Combination Product (y/n)N
Reporter Country CodeIN
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
Report Date 01/13/2020
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 Date11/10/2020
Device Model Number3320
Device Catalogue Number3320
Device Lot Number0023063198
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer11/22/2019
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 12/23/2019
Initial Date FDA Received01/13/2020
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured12/11/2018
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
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