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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION INTERLOCK; DEVICE, VASCULAR, FOR PROMOTING EMBOLIZATION
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BOSTON SCIENTIFIC CORPORATION INTERLOCK; DEVICE, VASCULAR, FOR PROMOTING EMBOLIZATION Back to Search Results
Model Number 83779
Device Problems Break (1069); Difficult to Remove (1528); Failure to Advance (2524); Material Deformation (2976)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 01/11/2024
Event Type  malfunction  
Manufacturer Narrative
E1 - initial reporter facility name: (b)(6).
 
Event Description
It was reported that the interlocking arm was detached.The target lesion was located in the internal iliac artery.A 10mm x 30cm interlock was selected for use.During the procedure, stc18 microcatheter together with a non boston scientific single curve catheter was used to deliver the coil, however it was felt abnormally unsmooth, and the coil could no longer be advanced after delivered half into the patient's body.It was noted that the delivery guidewire was severely bent, and during recapturing, it was noted that it could not be withdrawn into the protector.It had to be completed removed and the interlocking arm detached.The procedure was then completed with another of same device.No complications were reported, and the patient was stable post procedure.
 
Manufacturer Narrative
E1 - initial reporter facility name: (b)(6).Device evaluated by mfr: the introducer sheath and the pusher wire were returned with a non-boston scientific (bsci) catheter.It was observed that the pusher wire was bent at the coil, heat shrink tetrafluoroethylene (tfe) tubing and end pusher wire.The functional could not be performed due the main coil and the pusher wire are not interlocking.No other issues were identified during the product analysis.
 
Event Description
It was reported that the interlocking arm was detached.The target lesion was located in the internal iliac artery.A 10mm x 30cm interlock was selected for use.During the procedure, stc18 microcatheter together with a non boston scientific single curve catheter was used to deliver the coil, however it was felt abnormally unsmooth, and the coil could no longer be advanced after delivered half into the patient's body.It was noted that the delivery guidewire was severely bent, and during recapturing, it was noted that it could not be withdrawn into the protector.It had to be completed removed and the interlocking arm detached.The procedure was then completed with another of same device.No complications were reported, and the patient was stable post procedure.
 
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Brand Name
INTERLOCK
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 Key18707372
MDR Text Key336416427
Report Number2124215-2024-05162
Device Sequence Number1
Product Code KRD
UDI-Device Identifier08714729765035
UDI-Public08714729765035
Combination Product (y/n)N
Reporter Country CodeCH
PMA/PMN Number
K132578
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 03/29/2024
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 Number83779
Device Catalogue Number83779
Device Lot Number0031938697
Was Device Available for Evaluation? Device Returned to Manufacturer
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 01/25/2024
Initial Date FDA Received02/14/2024
Supplement Dates Manufacturer Received03/11/2024
Supplement Dates FDA Received03/29/2024
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured07/03/2023
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
Treatment
MICROCATHETER: CORDIS; MICROCATHETER: CORDIS
Patient Age55 YR
Patient SexFemale
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