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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION CAROTID WALLSTENT; STENT, CAROTID

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BOSTON SCIENTIFIC CORPORATION CAROTID WALLSTENT; STENT, CAROTID Back to Search Results
Model Number 26606
Device Problem Difficult to Remove (1528)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 01/24/2022
Event Type  malfunction  
Manufacturer Narrative
Device evaluated by mfr.: a carotid device was returned for analysis.A visual and tactile examination identified that the distal end of the t connector had come detached and moved down along the delivery system.The device was returned with the stent fully mounted in the correct location on the device.
 
Event Description
Reportable based on device analysis completed on 11mar2022.It was reported that removal difficulties were encountered.The target lesion was located in a coronary artery.After preparation of a 10.0-24 carotid monorail wallstent, it was reinserted into the hoop.When it was selected for use, severe resistance was noted upon removal from the hoop.The procedure was completed with another of the same device.There were no patient complications reported.However, returned device analysis revealed that distal end of t-connector was detached and moved along the delivery system.
 
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Brand Name
CAROTID WALLSTENT
Type of Device
STENT, CAROTID
Manufacturer (Section D)
BOSTON SCIENTIFIC CORPORATION
two scimed place
maple grove MN 55311
Manufacturer (Section G)
BOSTON SCIENTIFIC CORPORATION
ballybrit business park
galway
EI  
Manufacturer Contact
jay johnson
two scimed place
maple grove, MN 55311
7634942574
MDR Report Key14052954
MDR Text Key288873008
Report Number2134265-2022-04124
Device Sequence Number1
Product Code NIM
Combination Product (y/n)N
Reporter Country CodeJA
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Foreign,Health Professional,Company Representative,Distributor
Reporter Occupation Physician
Type of Report Initial
Report Date 04/08/2022
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 Number26606
Device Catalogue Number26606
Device Lot Number0027276181
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer02/23/2022
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 03/11/2022
Initial Date FDA Received04/08/2022
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured05/08/2021
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 Age79 YR
Patient SexMale
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