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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 Problems Material Deformation (2976); Material Integrity Problem (2978); Mechanical Jam (2983); Physical Resistance/Sticking (4012)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 07/17/2023
Event Type  malfunction  
Event Description
It was reported that the procedure was cancelled.The over 90% stenosed target lesion was located in the moderately tortuous and severely calcified left anterior descending artery.A 1.25mm rotalink burr was selected for angiography and percutaneous coronary intervention.When manipulating the knob during the procedure, difficulty was encountered with the advancer movement both forward and backward and the guidewire could not exit from the tail end of the advancer.Upon checking, it was noted that the end of the burr was kinked and damaged and this might have led to the advancer movement difficulty.The physician decided to end the procedure and reschedule as the procedure had been ongoing for too long and became intolerable.No complications were reported, and the patient was stable post procedure.
 
Manufacturer Narrative
E1 - initial reporter address 1: (b)(6).
 
Manufacturer Narrative
Corrected d4 lot number from 0029973095 to 0029789520.E1 - initial reporter address 1: (b)(6).Device evaluated by mfr: the complaint device was received for product analysis.The handshake connection, sheath, burr, and coil were microscopically and visually examined.Inspection of the device revealed that the coil was severely kinked and stretched at the handshake connection.As the rotawire used in the procedure was not returned for analysis, testing was performed using a test rotawire.The test wire was able to insert through the annulus, but was unable to pass the damage to the coil.In order to determine the functionality of the returned burr catheter with the advancer knob, a test advancer was used.When the burr catheter was connected to the test advancer and the advancer knob was moved, resistance was felt due to the damaged coil.No other issues were identified during the product analysis.
 
Event Description
It was reported that the procedure was cancelled.The over 90% stenosed target lesion was located in the moderately tortuous and severely calcified left anterior descending artery.A 1.25mm rotalink burr was selected for angiography and percutaneous coronary intervention.When manipulating the knob during the procedure, difficulty was encountered with the advancer movement both forward and backward and the guidewire could not exit from the tail end of the advancer.Upon checking, it was noted that the end of the burr was kinked and damaged and this might have led to the advancer movement difficulty.The physician decided to end the procedure and reschedule as the procedure had been ongoing for too long and became intolerable.No complications were reported, and the patient was stable post procedure.
 
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Brand Name
ROTALINK BURR
Type of Device
CATHETER, CORONARY, ATHERECTOMY
Manufacturer (Section D)
BOSTON SCIENTIFIC CORPORATION
300 boston scientific way
marlborough MA 01752
Manufacturer (Section G)
BOSTON SCIENTIFIC CORK LIMITED
model farm road
cork T12 Y K88
EI   T12 YK88
Manufacturer Contact
rachel shields
4100 hamline ave n
arden hills, MN 55112
6512422111
MDR Report Key17482324
MDR Text Key321258572
Report Number2124215-2023-40643
Device Sequence Number1
Product Code MCX
UDI-Device Identifier08714729185864
UDI-Public08714729185864
Combination Product (y/n)N
Reporter Country CodeCH
PMA/PMN Number
P900056
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Other,Foreign,Health Professional,Company Representative,Distributor
Reporter Occupation Physician
Type of Report Initial,Followup
Report Date 09/07/2023
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 Model Number3320
Device Catalogue Number3320
Device Lot Number0029789520
Was Device Available for Evaluation? Device Returned to Manufacturer
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 07/18/2023
Initial Date FDA Received08/08/2023
Supplement Dates Manufacturer Received08/17/2023
Supplement Dates FDA Received09/07/2023
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured07/19/2022
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
Patient Age72 YR
Patient SexMale
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