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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION ROTALINK PLUS; CATHETER, CORONARY, ATHERECTOMY
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BOSTON SCIENTIFIC CORPORATION ROTALINK PLUS; CATHETER, CORONARY, ATHERECTOMY Back to Search Results
Model Number 3241
Device Problems Failure to Advance (2524); Gas/Air Leak (2946)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 02/16/2023
Event Type  malfunction  
Event Description
It was reported that the procedure was not completed.Vascular access was obtained via right radial artery.The de novo, eccentric, sub-totally occluded target lesion was located in the moderately tortuous and severely calcified ostial left anterior descending artery.A 1.50mm rotalink plus and a 330cm rotawire guidewire were selected for use.During the procedure, ablation was conducted five times, but the device was unable to cross the target lesion.The system was then pulled out and upon inspection outside the patient, the physician observed the rotawire was kinked at the distal part, and the rotalink device was leaking.Consequently, the procedure was stopped, and the physician decided to refer the patient to the surgeon due to the complexity of the case (multivessel) and the cost for another pci attempt was higher compared to surgery.No complications were reported, and the patient was stable post procedure.
 
Manufacturer Narrative
Patient age at time of event: 18 years or older.Initial reporter address 1: (b)(6).
 
Manufacturer Narrative
(b)(6).Device evaluated by mfr: the device was returned for evaluation.The advancer, handshake connections, sheath, coil, burr and annulus were visually examined.Inspection of the device found that the coil was kinked and stretched at the handshake connection.Functional testing was performed by attempting to rotate the drive shaft and the drive shaft was able to be rotated.The rotablator was connected to the rotablator control console system.The device stalled and would not run due to the damaged coil.The sound of air escaping the device was heard during the device stall.The kinked and stretched coil caused the device to stall, leak air, and was considered to be a likely contributor to the reported difficulties in crossing the lesion.No other issues were identified during the product analysis.
 
Event Description
It was reported that the procedure was not completed.Vascular access was obtained via right radial artery.The de novo, eccentric, sub-totally occluded target lesion was located in the moderately tortuous and severely calcified ostial left anterior descending artery.A 1.50mm rotalink plus and a 330cm rotawire guidewire were selected for use.During the procedure, ablation was conducted five times, but the device was unable to cross the target lesion.The system was then pulled out and upon inspection outside the patient, the physician observed the rotawire was kinked at the distal part, and the rotalink device was leaking.Consequently, the procedure was stopped, and the physician decided to refer the patient to the surgeon due to the complexity of the case (multivessel) and the cost for another pci attempt was higher compared to surgery.No complications were reported, and the patient was stable post procedure.
 
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Brand Name
ROTALINK PLUS
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
EI  
Manufacturer Contact
jeff wallner
4100 hamline ave n
arden hills, MN 55112
6515811560
MDR Report Key16723944
MDR Text Key313127814
Report Number2124215-2023-17049
Device Sequence Number1
Product Code MCX
UDI-Device Identifier08714729228363
UDI-Public08714729228363
Combination Product (y/n)N
Reporter Country CodeID
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 06/06/2023
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 Expiration Date04/08/2024
Device Model Number3241
Device Catalogue Number3241
Device Lot Number0029362262
Was Device Available for Evaluation? Device Returned to Manufacturer
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 03/24/2023
Initial Date FDA Received04/12/2023
Supplement Dates Manufacturer Received05/19/2023
Supplement Dates FDA Received06/06/2023
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured05/09/2022
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
Treatment
GUIDE CATHETER - EBU3.5/7FR; GUIDE CATHETER - EBU3.5/7FR; MICROCATHETER - FINECROSS; MICROCATHETER - FINECROSS
Patient SexMale
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