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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION ROTAPRO; CATHETER, CORONARY, ATHERECTOMY
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BOSTON SCIENTIFIC CORPORATION ROTAPRO; CATHETER, CORONARY, ATHERECTOMY Back to Search Results
Model Number 3243
Device Problems Mechanical Jam (2983); Adverse Event Without Identified Device or Use Problem (2993)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 03/01/2023
Event Type  malfunction  
Event Description
It was reported that the procedure failed.A 1.25mm rotapro and rotawire were selected for use.During the course of the procedure, it was noted that the rotawire blocked into the rotablator device.Consequently, the procedure failed.
 
Manufacturer Narrative
Device evaluated by manufacturer: returned product consisted of the rotapro atherectomy system.The burr catheter was connected to the advancer unit.The advancer, handshake connections, sheath, coil, burr and annulus were visually and microscopically examined.Inspection of the device revealed that the coil was kinked and stretched at the handshake connection.The rotawire used in the procedure was returned and used for analysis.The wire was inserted into the annulus and advanced up to the damaged coil; however, the wire wouldn't pass the damaged coil.When the coil is kinked and stretched, the damage will not allow the guidewire to be advanced.Product analysis confirmed the reported events, as the coil was kinked and stretched, restricting the guidewire from advancing through the device.
 
Event Description
It was reported that the procedure failed.A 1.25mm rotapro and rotawire were selected for use.During the course of the procedure, it was noted that the rotawire blocked into the rotablator device.Consequently, the procedure failed.
 
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Brand Name
ROTAPRO
Type of Device
CATHETER, CORONARY, ATHERECTOMY
Manufacturer (Section D)
BOSTON SCIENTIFIC CORPORATION
300 boston scientific way
marlborough MA 01752
Manufacturer (Section G)
BOSTON SCIENTIFIC CORPORATION
model farm road
cork
EI  
Manufacturer Contact
jeff wallner
4100 hamline ave n
arden hills, MN 55112
6515811560
MDR Report Key16869792
MDR Text Key314576016
Report Number2124215-2023-21782
Device Sequence Number1
Product Code MCX
UDI-Device Identifier08714729893356
UDI-Public08714729893356
Combination Product (y/n)N
Reporter Country CodeFR
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Foreign,Health Professional,Company Representative
Reporter Occupation Physician
Type of Report Initial,Followup
Report Date 06/27/2023
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 Number3243
Device Catalogue Number3243
Device Lot Number0030344506
Was Device Available for Evaluation? Device Returned to Manufacturer
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 04/12/2023
Initial Date FDA Received05/04/2023
Supplement Dates Manufacturer Received06/20/2023
Supplement Dates FDA Received06/27/2023
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured10/14/2022
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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