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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 Leak/Splash (1354); Material Split, Cut or Torn (4008)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 02/20/2024
Event Type  malfunction  
Event Description
It was reported that saline leaked from a shaft hole.A 1.50mm rotalink plus was selected for use.During procedure, it was noted that saline leaked from a shaft hole.The procedure was completed and no patient complications were reported.
 
Event Description
It was reported that saline leaked from a shaft hole.A 1.50mm rotalink plus was selected for use.During procedure, it was noted that saline leaked from a shaft hole.The procedure was completed and no patient complications were reported.
 
Manufacturer Narrative
Device evaluated by mfr.: the device was returned for analysis.Visual inspection of the device found that the sheath was torn at 23cm from the burr housing strain relief.As the advancer used in the procedure was not returned, a test advancer was used during functional testing analysis.When the test advancer was connected to the returned burr catheter and liquid infusion was performed, fluid was leaking from the torn portion of the sheath.Product analysis confirmed the reported events, as the sheath was torn and fluid was leaking from the torn portion of the sheath during testing.
 
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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 CORPORATION
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 Key18975490
MDR Text Key338614043
Report Number2124215-2024-15882
Device Sequence Number1
Product Code MCX
UDI-Device Identifier08714729228363
UDI-Public08714729228363
Combination Product (y/n)N
Reporter Country CodeAS
PMA/PMN Number
P900056
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Other,Foreign,Health Professional,Company Representative
Reporter Occupation Physician
Type of Report Initial,Followup
Report Date 04/29/2024
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 Number3241
Device Catalogue Number3241
Device Lot Number0032151692
Was Device Available for Evaluation? Device Returned to Manufacturer
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 02/28/2024
Initial Date FDA Received03/25/2024
Supplement Dates Manufacturer Received04/05/2024
Supplement Dates FDA Received04/29/2024
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured08/04/2023
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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