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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION EMBOLD FIBERED DETACHABLE COIL SYSTEM; DEVICE, VASCULAR, FOR PROMOTING EMBOLIZATION
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BOSTON SCIENTIFIC CORPORATION EMBOLD FIBERED DETACHABLE COIL SYSTEM; DEVICE, VASCULAR, FOR PROMOTING EMBOLIZATION Back to Search Results
Model Number 83910
Device Problems Break (1069); Stretched (1601); Material Protrusion/Extrusion (2979); Physical Resistance/Sticking (4012)
Patient Problem Foreign Body In Patient (2687)
Event Date 02/28/2024
Event Type  Injury  
Event Description
It was reported that the coil stretched from the groin into the aorta.A 2x6 embold fibered detachable coil system was selected for use in a gastrointestinal (gi) bleed embolization procedure.The vessel was mildly tortuous.During the procedure, the coil was attempted to be implanted in an ileocolic branch.After breaking the proximal release perforation and pulling back the pull wire, resistance was experienced removing the delivery system of the coil.The coil stretched from the groin into the aorta.Several hours were spent attempting to snare the coil, but it was unsuccessful.The coil continued to stretch.The patient was sent to the operating room (or).The surgery was successful at retrieving 99% of the coil, but a small amount was left in the distal portion of the vessel.
 
Manufacturer Narrative
Correction: added h6 device code.Device eval by manufacturer: the device was returned for analysis.The delivery sheath, delivery wire, and a small, retrieved piece of coil were returned.Microscopic analysis showed that the perforations were broken.The delivery wire was returned with no damage.The proximal coupler was attached to the delivery wire.No damage on the delivery sheath or delivery wire was noticed.A small piece of coil was retrieved from the patient's vessel and was returned.Inspection of the remainder of the device, apart from the observed damage, revealed no other damage or irregularities.The complaint was confirmed for stretching and breaks.
 
Event Description
It was reported that the coil stretched from the groin into the aorta.A 2x6 embold fibered detachable coil system was selected for use in a gastrointestinal (gi) bleed embolization procedure.The vessel was mildly tortuous.During the procedure, the coil was attempted to be implanted in an ileocolic branch.After breaking the proximal release perforation and pulling back the pull wire, resistance was experienced removing the delivery system of the coil.The coil stretched from the groin into the aorta.Several hours were spent attempting to snare the coil, but it was unsuccessful.The coil continued to stretch.The patient was sent to the operating room (or).The surgery was successful at retrieving 99% of the coil, but a small amount was left in the distal portion of the vessel.
 
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Brand Name
EMBOLD FIBERED DETACHABLE COIL SYSTEM
Type of Device
DEVICE, VASCULAR, FOR PROMOTING EMBOLIZATION
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 Key18969259
MDR Text Key338497105
Report Number2124215-2024-17494
Device Sequence Number1
Product Code KRD
UDI-Device Identifier08714729983538
UDI-Public08714729983538
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Health Professional,Company Representative
Reporter Occupation Physician
Type of Report Initial,Followup
Report Date 04/19/2024
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received03/25/2024
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model Number83910
Device Catalogue Number83910
Device Lot Number0033211291
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer03/21/2024
Is the Reporter a Health Professional? Yes
Date Manufacturer Received03/25/2024
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured01/15/2024
Is the Device Single Use? Yes
Type of Device Usage Initial
Patient Sequence Number1
Patient Outcome(s) Required Intervention; Hospitalization;
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