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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 Break (1069); Leak/Splash (1354); Material Rupture (1546); Device Dislodged or Dislocated (2923); Material Integrity Problem (2978); Activation Failure (3270)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 02/20/2023
Event Type  Injury  
Event Description
It was reported that after beginning to dislodge from the balloon, the stent failed to fully expand, and an additional device was required.An express ld vascular was selected for use in the pi stenting procedure.The target lesion was location in the left common iliac artery and was reported to be heavily calcified.A 0.035 in.Non-bsc guidewire was placed, followed by an 8f non-bsc introducer sheath.The target lesion was predilated using a percutaneous transluminal angioplasty (pta) balloon.The express ld vascular was introduced, and after pushing the device further out of the introducer sheath, it was noted that blood was coming out of the proximal portion of the express ld vascular into the inflation lumen.It was attempted to withdraw the entire system, but the stent was beginning to dislodge from the balloon, and was not able to be re-constrained.As the entire system was unable to be safely removed, the express ld vascular stent was attempted to be expanded using the attached balloon, but the attempt was unsuccessful.An attempt was made to expand the stent using a 50-cc syringe by hand, which resulted in the express ld vascular stent partially deploying within the vessel.The express ld vascular delivery system was attempted to be removed through the non-bsc introducer sheath, at which time the balloon detached from the shaft.The balloon remained firmly attached to the support wire and was partially retracted into the distal portion of non-bsc introducer sheath.The express ld vascular system and non-bsc introducer sheath were removed with the balloon, and the non-bsc guidewire remained in place.The introducer sheath was replaced.The deployed stent was not fully expanded, so an additional balloon catheter was used to post-dilate.
 
Event Description
It was reported that after beginning to dislodge from the balloon, the stent failed to fully expand, and an additional device was required.An express ld vascular was selected for use in the pi stenting procedure.The target lesion was location in the left common iliac artery and was reported to be heavily calcified.A 0.035 in.Non-bsc guidewire was placed, followed by an 8f non-bsc introducer sheath.The target lesion was predilated using a percutaneous transluminal angioplasty (pta) balloon.The express ld vascular was introduced, and after pushing the device further out of the introducer sheath, it was noted that blood was coming out of the proximal portion of the express ld vascular into the inflation lumen.It was attempted to withdraw the entire system, but the stent was beginning to dislodge from the balloon, and was not able to be re-constrained.As the entire system was unable to be safely removed, the express ld vascular stent was attempted to be expanded using the attached balloon, but the attempt was unsuccessful.An attempt was made to expand the stent using a 50-cc syringe by hand, which resulted in the express ld vascular stent partially deploying within the vessel.The express ld vascular delivery system was attempted to be removed through the non-bsc introducer sheath, at which time the balloon detached from the shaft.The balloon remained firmly attached to the support wire and was partially retracted into the distal portion of non-bsc introducer sheath.The express ld vascular system and non-bsc introducer sheath were removed with the balloon, and the non-bsc guidewire remained in place.The introducer sheath was replaced.The deployed stent was not fully expanded, so an additional balloon catheter was used to post-dilate.
 
Manufacturer Narrative
Device media analysis: a visual examination identified that the balloon of the device had been subjected to positive pressure.The stent had been fully deployed from the balloon and was not returned for analysis.Blood noted inside the balloon was evidence of a device leak.A leak test could not be carried out due to shaft damage.A visual examination found no damage or issues with the marker bands or tip of the device.A visual and tactile examination found the shaft of the device to be completely separated at the proximal balloon sleeve.This type of damage was consistent with excessive force being applied to the device.No other issues were identified during the product analysis.Updated fields: g1 - mfr contact first name, mfr contact last name, mfr contact phone number, mfr contact email.H6 - device codes, component codes, evaluation method codes, evaluation result codes, evaluation conclusion codes.
 
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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
jeff wallner
4100 hamline ave n
arden hills, MN 55112
6515811560
MDR Report Key16546521
MDR Text Key311325691
Report Number2124215-2023-10426
Device Sequence Number1
Product Code FGE
Combination Product (y/n)N
Reporter Country CodeLH
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 04/21/2023
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model Number20212
Device Catalogue Number20212
Device Lot Number0029115911
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer03/14/2023
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 02/24/2023
Initial Date FDA Received03/15/2023
Supplement Dates Manufacturer Received03/28/2023
Supplement Dates FDA Received04/21/2023
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured03/27/2022
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 Outcome(s) Required Intervention;
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