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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION EXPRESS LD VASCULAR; CATHETER, BILIARY, DIAGNOSTIC
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BOSTON SCIENTIFIC CORPORATION EXPRESS LD VASCULAR; CATHETER, BILIARY, DIAGNOSTIC Back to Search Results
Model Number 20212
Device Problems Entrapment of Device (1212); Difficult to Advance (2920); Material Deformation (2976)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 07/08/2022
Event Type  malfunction  
Event Description
It was reported that stent damage and device entrapment occurred.The target lesion was located in the iliac artery.A 8.0x60x135 cm express ld vascular stent was advanced into the patient through the sheath.However, it was found that the stent got stuck in the sheath, and there was large resistance.The physician pushed and pulled the stent for several times, but the stent could not move.He then removed the stent and the sheath together.The physician cut the sheath and found that the stent was kinked.The procedure was completed using a long sheath and a different stent.There were no patient complications reported and the patient status was stable.
 
Event Description
It was reported that stent damage and device entrapment occurred.The target lesion was located in the iliac artery.A 8.0x60x135 cm express ld vascular stent was advanced into the patient through the sheath.However, it was found that the stent got stuck in the sheath, and there was large resistance.The physician pushed and pulled the stent for several times, but the stent could not move.He then removed the stent and the sheath together.The physician cut the sheath and found that the stent was kinked.The procedure was completed using a long sheath and a different stent.There were no patient complications reported and the patient status was stable.
 
Manufacturer Narrative
Device evaluated by mfr.: express-vascular ld pmtd 8.0x60x135 cm, batch# 24201332 was received for analysis.The indicated introducer sheath size for this express ld device is a 7fr.The sheath used by the customer was not returned for analysis.During analysis the investigator was unable to advance the device through a 7fr boston scientific sheath due to a severe kink in the shaft and stent a visual examination of the returned device confirmed that the balloon had not been subjected to positive pressure.No issues were noted with the balloon material.The device was received with stent fully mounted in the correct position on the delivery system.A visual examination identified a severe kink in the centre of the stent.This type of damage is consistent with excessive force being applied to the device.A visual and tactile examination identified a severe kink in the shaft of the device located at the same location as the stent kink.This type of damage is consistent with excessive force being applied to the device.A visual examination identified no issues with the tip that could potentially have contributed to the complaint incident.This concludes the product analysis.
 
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Brand Name
EXPRESS LD VASCULAR
Type of Device
CATHETER, BILIARY, DIAGNOSTIC
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
4100 hamline ave n
arden hills, MN 55112
6515810888
MDR Report Key15306868
MDR Text Key302261632
Report Number2124215-2022-30046
Device Sequence Number1
Product Code FGE
Combination Product (y/n)N
Reporter Country CodeCH
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,Followup
Report Date 09/30/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received08/26/2022
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Expiration Date07/31/2022
Device Model Number20212
Device Catalogue Number20212
Device Lot Number0024201332
Was Device Available for Evaluation? Device Returned to Manufacturer
Is the Reporter a Health Professional? Yes
Date Manufacturer Received09/12/2022
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured08/01/2019
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 Age69 YR
Patient Weight86 KG
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