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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION INTERLOCK-35; DEVICE, VASCULAR, FOR PROMOTING EMBOLIZATION
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BOSTON SCIENTIFIC CORPORATION INTERLOCK-35; DEVICE, VASCULAR, FOR PROMOTING EMBOLIZATION Back to Search Results
Model Number 83787
Device Problems Entrapment of Device (1212); Premature Activation (1484); Difficult to Remove (1528); Adverse Event Without Identified Device or Use Problem (2993)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 01/11/2024
Event Type  malfunction  
Event Description
It was reported the coil deployed prematurely and was stuck to the catheter tip when removed.This.035 interlock cube 10 mm x 40 cm coil system was selected for embolization of an aneurysm within the internal iliac.It was noted that there was moderate tortuosity.During insertion, the interventional radiologist attempted to pull the coil back a little bit; however, during this pulling back the coil detached inside the catheter.A 10 cm portion of the coil was stuck outside of the catheter and unable to push the coil out or pull it back.The catheter and the coil were removed from the patient together.The procedure was completed successfully using a new catheter and coil pack.No patient complications were reported.
 
Manufacturer Narrative
Device eval by manufacturer: this.035 interlock cube 10 mm x 40 cm was returned for analysis; however, only the mail coil was returned.Visual observations indicated that the main coil was bent and stretched at the coil arm and primary coil section.Also, the coil arm was detached.Functional testing could not be performed due the main coil and the pusher wire not interlocking, and with only the main coil being returned the reported observations of premature deployment and stuck to catheter tip could not be confirmed.The damage observed with the coil were likely related to difficulty withdrawing the catheter, which is indicative of the technique used by the physician and normal procedural difficulties encountered during the procedure.
 
Event Description
It was reported the coil deployed prematurely and was stuck to the catheter tip when removed.This.035 interlock cube 10 mm x 40 cm coil system was selected for embolization of an aneurysm within the internal iliac.It was noted that there was moderate tortuosity.During insertion, the interventional radiologist attempted to pull the coil back a little bit; however, during this pulling back the coil detached inside the catheter.A 10 cm portion of the coil was stuck outside of the catheter and unable to push the coil out or pull it back.The catheter and the coil were removed from the patient together.The procedure was completed successfully using a new catheter and coil pack.No patient complications were reported.
 
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Brand Name
INTERLOCK-35
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 Key18567365
MDR Text Key333539872
Report Number2124215-2024-03479
Device Sequence Number1
Product Code KRD
UDI-Device Identifier08714729795513
UDI-Public08714729795513
Combination Product (y/n)N
Reporter Country CodeNL
PMA/PMN Number
K133208
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Other,Foreign,Health Professional,Company Representative
Reporter Occupation Physician
Type of Report Initial,Followup
Report Date 03/26/2024
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received01/23/2024
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Expiration Date03/22/2024
Device Model Number83787
Device Catalogue Number83787
Device Lot Number0027017530
Was Device Available for Evaluation? Device Returned to Manufacturer
Is the Reporter a Health Professional? Yes
Date Manufacturer Received03/01/2024
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured03/23/2021
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
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